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| Name | Class |
|---|---|
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
| AdvanceCor GmbH | INDUSTRY |
| Technical University of Munich | OTHER |
| German Federal Ministry of Education and Research |
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The main objective is to evaluate the efficacy and safety of treatment with 2 doses (80 and 160 mg) of Revacept versus placebo in patients with stable coronary artery disease undergoing PCI.
Revacept is a protein that is made up of an Fc fragment ("fragment crystallisable") fused to the GPVI receptor (the endogenous platelet collagen receptor). Consequently, Revacept binds to its ligand (collagen) on atherosclerotic plaques preventing circulating thrombocytes from binding to collagen exposed by the injured plaque. All this is achieved without affecting systemic hemostasis.
Thus, blocking of GPVI-dependent pathways by interfering with vascular collagen sites is commonly seen as an attractive target for an anti-platelet therapy of atherosclerotic diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revacept 80 mg | Experimental | single dose, intravenous |
|
| Revacept 160 mg | Experimental | single dose, intravenous |
|
| Placebo | Placebo Comparator | single dose, intravenous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revacept 80 mg | Drug | single dose, intravenous application of 80 mg Revacept |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint-composite endpoint of death and myocardial injury | A composite endpoint of death or myocardial injury (defined as increase in cardiac biomarker - high sensitivity cardiac troponin T of at least 5 times the upper limit of norm (ULN) within 48 hours from randomisation). | within 48 hours from randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | All cause mortality | within 30 days after randomisation |
| Myocardial infarction | Myocardial infarction | within 30 days after randomisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adnan Kastrati, MD | Deutsches Herzzentrum München | Study Chair |
| Steffen Massberg, MD | Klinikum der Universität München | Study Chair |
| Stefanie Schuepke, MD | Deutsches Herzzentrum Muenchen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum München | Munich | Bavaria | 80636 | Germany | ||
| Universitätsmedizin Berlin, Campus Benjamin Franklin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33787834 | Derived | Mayer K, Hein-Rothweiler R, Schupke S, Janisch M, Bernlochner I, Ndrepepa G, Sibbing D, Gori T, Borst O, Holdenrieder S, Kupka D, Petzold T, Bradaric C, Okrojek R, Leistner DM, Trippel TD, Munzel T, Landmesser U, Pieske B, Zeiher AM, Gawaz MP, Hapfelmeier A, Laugwitz KL, Schunkert H, Kastrati A, Massberg S. Efficacy and Safety of Revacept, a Novel Lesion-Directed Competitive Antagonist to Platelet Glycoprotein VI, in Patients Undergoing Elective Percutaneous Coronary Intervention for Stable Ischemic Heart Disease: The Randomized, Double-blind, Placebo-Controlled ISAR-PLASTER Phase 2 Trial. JAMA Cardiol. 2021 Jul 1;6(7):753-761. doi: 10.1001/jamacardio.2021.0475. |
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| OTHER_GOV |
with 2 doses (80 and 160 mg) of Revacept versus placebo
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| Revacept 160 mg |
| Drug |
single dose, intravenous application of 180 mg Revacept |
|
| Placebo | Drug | single dose, intravenous application of Placebo solution |
|
| PCI-related (type 4) myocardial infarction | PCI-related (type 4) myocardial infarction | within 30 days after randomisation |
| Definite stent thrombosis | Definite stent thrombosis | within 30 days after randomisation |
| Urgent coronary revascularization | Urgent coronary revascularization | within 30 days after randomisation |
| Stroke | Stroke | within 30 days after randomisation |
| Peak potprocedural high-sensitivity troponin T level | Peak potprocedural high-sensitivity troponin T level | within 48 hours after randomisation |
| Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint) | Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint) | within 30 days after randomisation |
| Berlin |
| 12203 |
| Germany |
| Charité - Universitätsmedizin Berlin, Campus Virchow | Berlin | 13353 | Germany |
| Universitätsklinikum Frankfurt, Medizinische Klinik III, Kardiologie | Frankfurt am Main | 60590 | Germany |
| Universtätsmedizin Mainz, Zentrum für Kardiologie/Kardiologie I | Mainz | 55131 | Germany |
| Klinikum der Universität München, Medizinische Klinik und Poliklinik I | Munich | 81377 | Germany |
| Klinikum rechts der Isar, I. Medizinische Klinik und Poliklinik | Munich | 81675 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C559357 | Revacept |
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