A Phase 3 Study of Zalunfiban in Subjects With ST‑elevation MI (CELEBRATE)

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Information provided by:

CeleCor Therapeutics

Last updated:

05/18/2022

Trial identifier:

NCT04825743

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Simplified Study Description Detailed Study Description

Study Description

Brief summary:

This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. These subjects will be evaluated by (para)medics who transport the subjects to the participating hospitals in Europe and North America. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either zalunfiban Dose 1 (0.110 mg/kg) or zalunfiban Dose 2 (0.130 mg/kg) or placebo

Detailed Description:

Subjects will be screened in the ambulance based on the information available; those fulfilling the eligibility criteria who have provided verbal witnessed/short written/Exception from Informed Consent Requirements (EFIC) process informed consent will be randomized and enrolled in the study. Following a single weight-based dose of subcutaneous study drug administered by the ambulance staff, the patient will be transferred to the clinical site PCI center for angiography and intervention.

Regular standard of care is performed from the provision of informed consent through the last study mandated subject visit. Concomitant medications will be recorded. Treatment with IV P2Y12 antagonists or other αIIbβ3 receptor before PCI/angiography is prohibited. Demographics, concomitant medications, vital signs, and medical history will be collected in the CRF. Adverse events, bleeding events and injection site reactions will be collected. Angiography and PCI details will be recorded. Full written informed consent will be obtained. Additional blood samples for safety will be collected at 1, 6, 24 and 72 hours (or hospital discharge) post-PCI/angiography. Blood samples for high-sensitive cardiac troponin T (upon arrival and 24 hours post PCI/angiography) and NT-ProBNP (24 hours post PCI/angiography) will be assessed by central laboratory. Follow up phone contacts will occur at 30 days to report AEs, bleeding events, and injection site reactions, and 12-months to record mortality, and hospitalizations for heart failure or atrial fibrillation, and [in the event of stroke], 90 days (±2 weeks) to record the stroke disability.

Angiography/PCI data and ECGs will be evaluated at independent Core Laboratories. An independent, blinded Clinical Events Committee will provide central adjudication of all clinical endpoint events. A DSMB will examine the safety data in an ongoing manner and to alert the Steering Committee in case of clinically concerning safety issues that should lead to consideration of altering the trial, and can recommend modification of the study protocol based on pre-specified rules.

The duration of participation for each subject will be 12 months (± 1 month), including enrollment, study drug administration, hospitalization, and phone contact follow-up at 30 days (+ 7 days) and 12 months (± 1 month).

Official Title

Glossary term:

Title

The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

A Phase 3 Prospective, Blinded, Randomized, Placebo Controlled, International Multicenter Study to Assess the Safety and Efficacy of a Single Subcutaneous Injection of Zalunfiban in Subjects With ST-elevation Myocardial Infarction in the Pre-hospital Setting

Type of Study

Glossary term:

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access. Interventional studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study. Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.

Interventional

Enrollment (Anticipated)

Glossary term:

Enrollment

The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

2499

Phase

Glossary term:

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). Phase 1: Clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2: Clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Phase 3: Clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. Phase 4: Clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use. Not Applicable: Trials without FDA-defined phases, including trials of devices or behavioral interventions.

Phase 3

Other Study ID Numbers

Glossary term:

Other study IDs

Identifiers or ID numbers other than the NCT number that are assigned to a clinicalstudy by the study's sponsor, funders, or others. These numbers may include unique identifiers from othertrial registries and National Institutes of Health grant numbers.

CEL-03

Intervention / Treatment

Glossary term:

Intervention/treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Drug: zalunfiban
Drug: Placebo

Study Start (Actual)

Glossary term:

Study start date

The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Apr 24, 2021

Primary Completion (Anticipated)

Glossary term:

Primary completion date

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

Dec 31, 2023

Study Completion (Anticipated)

Glossary term:

Study completion date

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.

Dec 31, 2024

First Submitted Date

Glossary term:

First submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).

Mar 29, 2021

First Submitted that Met QC Criteria

Glossary term:

First submitted that met QC criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Mar 29, 2021

First Posted (Actual)

Glossary term:

First posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.

Apr 01, 2021

Last Update Submitted that Met MQ Criteria

Glossary term:

Last update submitted that met QC criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

May 16, 2022

Last Update Posted (Actual)

Glossary term:

Last update posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date)and the last update posted date.

May 18, 2022

Other important Dates

Contacts and Locations

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Contacts

Study Contact

Glossary term:

Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Name: Robert S Hillman, PhD

Phone Number: 8587779750

Email: rhillman@celecor.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. For general information about clinical research, read Guides to Clinical Trials.

Eligibility Criteria

Ages Eligible for Study:

Glossary term:

Age

A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

18 Years +

Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers

A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Sexes Eligible for Study:

Glossary term:

Sex

A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

All

Description:

Inclusion Criteria:

Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years or ≥55 years (for Czech Republic study sites only).
Weight (by history) between 52 and 130 kg.
Subjects with STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in two adjacent ECG leads, in whom the total duration of symptoms is 4 hours maximum. If time of symptom onset is uncertain, the cardiologist may be contacted to confirm inclusion criteria.
Exception from Informed Consent Requirements (EFIC) process, verbal witnessed/ short written informed consent, or written informed consent signed by subject or legally authorized representative/independent witness will be obtained in the acute phase by (para)medics, according to local applicable legal regulations. Subject is willing and able to give informed consent. Written informed consent will be obtained as soon as the subject's clinical condition allows it.

Exclusion Criteria:

Cardio Pulmonary Resuscitation (CPR) for current Out of Hospital Cardiac Arrest (OHCA).
Presenting with systolic blood pressure <90 mmHg (confirmed on repeat assessment) and heart rate >100 beats per minute (bpm).
Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines).
Currently treated with renal dialysis.
Current treatment with oral anticoagulation (Vitamin K antagonists [VKA] or direct oral anticoagulants [DOACs]).
Major surgery, or trauma or bleeding leading to hospitalization, within the past month.
Known history of ischemic or hemorrhagic stroke.
Known severe anemia (regular blood transfusion needed).
Previously enrolled in this study.
Participation in another clinical study with an investigational product or device within the past month.
Life expectancy less than one year.

Study Plan

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

How is the study designed?

Design Details:

Primary Purpose:

Treatment

Allocation:

Randomized

Interventional Model:

Parallel Assignment

Number of Arms:

Arms and Interventions:

Participant Group / Arm

Glossary term:

Arm

A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.

Intervention / Treatment

Glossary term:

Intervention/treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Placebo Comparator: Placebo

Subjects will receive a single subcutaneous injection containing Placebo in the ambulance after diagnosis of STEMI and before hospital arrival

Placebo Comparator: Placebo

Subjects will receive a single subcutaneous injection containing Placebo in the ambulance after diagnosis of STEMI and before hospital arrival

Drug: Placebo

Single-use vials and syringes in randomization kits containing zalunfiban Dose 1 (0.110 mg/kg), zalunfiban Dose 2 (0.130 mg/kg), or placebo will be dispensed in the ambulance

Drug: Placebo

Single-use vials and syringes in randomization kits containing zalunfiban Dose 1 (0.110 mg/kg), zalunfiban Dose 2 (0.130 mg/kg), or placebo will be dispensed in the ambulance

Experimental: zalunfiban Dose 1 (0.110 mg/kg)

Subjects will receive a single subcutaneous injection containing zalunfiban Dose 1 (0.110 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival

Experimental: zalunfiban Dose 1 (0.110 mg/kg)

Subjects will receive a single subcutaneous injection containing zalunfiban Dose 1 (0.110 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival

Drug: zalunfiban

zalunfiban is a novel small molecule inhibitor of the platelet αIIbβ3 receptor specifically designed for first medical contact therapy of ST-elevation myocardial infarction (STEMI).

Drug: zalunfiban

zalunfiban is a novel small molecule inhibitor of the platelet αIIbβ3 receptor specifically designed for first medical contact therapy of ST-elevation myocardial infarction (STEMI).

Experimental: zalunfiban Dose 2 (0.130 mg/kg)

Subjects will receive a single subcutaneous injection containing zalunfiban Dose 2 (0.130 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival

Experimental: zalunfiban Dose 2 (0.130 mg/kg)

Subjects will receive a single subcutaneous injection containing zalunfiban Dose 2 (0.130 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival

Drug: zalunfiban

zalunfiban is a novel small molecule inhibitor of the platelet αIIbβ3 receptor specifically designed for first medical contact therapy of ST-elevation myocardial infarction (STEMI).

Drug: zalunfiban

zalunfiban is a novel small molecule inhibitor of the platelet αIIbβ3 receptor specifically designed for first medical contact therapy of ST-elevation myocardial infarction (STEMI).

What is the study measuring?

Primary Outcome Measures

Glossary term:

Primary outcome measure

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.

Outcome Measure

primary efficacy -clinical outcome

Measure Description

As assessed by a 7-point scale. The 7 outcomes, ranking from worst to best are: Death (all cause) at 30 days follow-up Stroke at 30 days follow-up Recurrent MI (type 1 to 4 MI) at 30 days follow-up Acute stent thrombosis at 24 hours post-PCI/angiography New onset heart failure or rehospitalization for heart failure at 30 days follow-up MI with hs-cTnT levels ≥10x ULN at 24 hours post-PCI/angiography None of the above

Timeframe

at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo

Outcome Measure

primary safety- bleeding events [BARC criteria]

Measure Description

• To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] severe or life threatening criterion for safety assessment and according to the Bleeding Academic Research Consortium [BARC] 3C and 5 criteria for information only)

Timeframe

after a single subcutaneous injection of zalunfiban versus placebo at 30 days post-PCI/angiography

Outcome Measure

Measure Description

Timeframe

primary efficacy -clinical outcome

at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo

primary safety- bleeding events [BARC criteria]

To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] severe or life threatening criterion for safety assessment and according to the Bleeding Academic Research Consortium [BARC] 3C and 5 criteria for information only)

after a single subcutaneous injection of zalunfiban versus placebo at 30 days post-PCI/angiography

Measure Description

Timeframe

secondary efficacy-restoration of the coronary artery blood flow

before PCI (or coronary angiography if no PCI is performed)

efficacy-resolution of ST segment deviation

To assess resolution of ST segment deviation post-PCI/angiography after a single subcutaneous injection of zalunfiban versus placebo

1 hour post-PCI/angiography

Efficacy-composite of all cause death, recurrent MI, acute stent thrombosis or blinded bail-out use of IV αIIbβ3 antagonists or IV P2Y12 antagonist

To assess a composite of all cause death, recurrent MI, acute stent thrombosis or blinded bail-out use of IV αIIbβ3 antagonists or IV P2Y12 antagonist

at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo

Efficacy-acute stent thrombosis

To assess incidence of definite, probable or possible acute stent thrombosis after a single subcutaneous injection of zalunfiban versus placebo

up to 24 hours post-PCI

Safety throughout the study by AE reporting

Recording of AEs and SAEs fibrillation up to 12-months follow-up

AEs up to 30 days follow-up; SAEs up to resolution/stabilization, the SAEs mortality, hospitalization for heart failure and atrial fibrillation up to 12-months follow-up

Safety-platelet count

To assess platelet count after a single subcutaneous injection of zalunfiban versus placebo

before PCI/angiography, at the end of the PCI/angiography, 6 and 24 hours post-PCI/angiography and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first)

Safety-bleeding events (ISTH and TIMI)

at 30 days follow-up

Safety-bleeding events (GUSTO mild and moderate, BARC type 2, 3 and 5, ISTH minor and/or major and TIMI minor and major)

To assess incidence of bleeding events according to GUSTO mild and moderate criteria, BARC type 2, 3 and 5 criteria, ISTH minor and or major bleeding, TIMI minor and major criteria

30 days follow-up

Safety-injection site reactions

To assess the injection site reactions of a single subcutaneous injection of zalunfiban versus placebo

baseline, 1-hour post-PCI/angiography, hospital discharge/72-hours post-PCI/angiography, and at 30 days follow-up

Sponsor and Collaborators

The Sponsor of a study is the organization or person that is conducting the study. They may provide resources needed to do the investigation.

Sponsor:

Glossary term:

Sponsor

The organization or person who initiates the study and who has authority and control over the study.

CeleCor Therapeutics

Investigators and Collaborators

Investigators:

Glossary term:

Investigator

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.

Central Contacts:

Robert S Hillman, PhD

Overall Officials:

Prof. Arnoud WJ Van 't Hof, MD PhD

Collaborators:

Glossary term:

Collaborator

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.

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Official Title Glossary term: Title The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

Enrollment (Anticipated) Glossary term: Enrollment The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

Study Start (Actual) Glossary term: Study start date The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Study Contact Glossary term: Contact The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Ages Eligible for Study: Glossary term: Age A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

Accepts Healthy Volunteers: Glossary term: Accepts Healthy Volunteers A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Description:

Design Details:

Primary Purpose:

Allocation:

Interventional Model:

Number of Arms:

Arms and Interventions:

Participant Group / Arm Glossary term: Arm A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.

Outcome Measure

Measure Description

Timeframe

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Outcome Measure

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Outcome Measure

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Outcome Measure

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Outcome Measure

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Outcome Measure

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Outcome Measure

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Outcome Measure

Measure Description

Timeframe

Sponsor: Glossary term: Sponsor The organization or person who initiates the study and who has authority and control over the study.

Investigators and Collaborators

Investigators and Collaborators

Investigators: Glossary term: Investigator A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.

Central Contacts:

Overall Officials:

Collaborators: Glossary term: Collaborator An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.

Publications

Publications of Study Results

General Publications

Publications Automatically Indexed to this Study by ClinicalTrials.Gov Identifier (NCT Number

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Official Title

Glossary term:

Title

The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

Enrollment (Anticipated)

Glossary term:

Enrollment

The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

Study Start (Actual)

Glossary term:

Study start date

The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Study Contact

Glossary term:

Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Ages Eligible for Study:

Glossary term:

Age

A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers

A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Participant Group / Arm

Glossary term:

Arm

A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.

Sponsor:

Glossary term:

Sponsor

The organization or person who initiates the study and who has authority and control over the study.

Investigators:

Glossary term:

Investigator

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.

Collaborators:

Glossary term:

Collaborator

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.