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Information provided by:
CeleCor Therapeutics
Last updated:
05/18/2022
Trial identifier:
NCT04825743
DisclaimerBrief 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:
Glossary term:
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
Glossary term:
Interventional
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2499
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Phase 3
Glossary term:
CEL-03
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Drug: zalunfiban
Drug: Placebo
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Apr 24, 2021
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Dec 31, 2023
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Dec 31, 2024
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Mar 29, 2021
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Mar 29, 2021
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Apr 01, 2021
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May 16, 2022
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May 18, 2022
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Name: Robert S Hillman, PhD
Phone Number: 8587779750
Email: rhillman@celecor.com
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.
Glossary term:
18 Years +
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No
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All
Inclusion Criteria:
Exclusion Criteria:
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.
Treatment
Randomized
Parallel Assignment
3
Glossary term:
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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).
Glossary term:
primary efficacy -clinical outcome
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
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
primary efficacy -clinical outcome
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
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
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secondary efficacy-restoration of the coronary artery blood flow
To assess restoration of the culprit coronary artery blood flow (corrected Thrombolysis in Myocardial Infarction [TIMI] Frame Count) before intended PCI (or post coronary angiography in case no PCI is performed) after a single subcutaneous injection of zalunfiban versus placebo
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)
To assess bleeding events (according to International Society on Thrombosis and Haemostasis [ISTH] Major and TIMI Major for information only) after a single subcutaneous injection of zalunfiban versus placebo
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
secondary efficacy-restoration of the coronary artery blood flow
To assess restoration of the culprit coronary artery blood flow (corrected Thrombolysis in Myocardial Infarction [TIMI] Frame Count) before intended PCI (or post coronary angiography in case no PCI is performed) after a single subcutaneous injection of zalunfiban versus placebo
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)
To assess bleeding events (according to International Society on Thrombosis and Haemostasis [ISTH] Major and TIMI Major for information only) after a single subcutaneous injection of zalunfiban versus placebo
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
The Sponsor of a study is the organization or person that is conducting the study. They may provide resources needed to do the investigation.
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