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Revacept, a Novel Inhibitor of Platelet Adhesion, in Patients Undergoing Elective PCI-Design and Rationale of the
Stefanie Schüpke1,2, Ralph Hein-Rothweiler3, Katharina Mayer1
1Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität, Munich, Germany.
Insights
Revacept, a novel antiplatelet therapy, aims to reduce ischemic events after percutaneous coronary intervention (PCI) without increasing bleeding risk. This study evaluates its efficacy and safety in patients undergoing PCI.
Area of Science:
- Cardiology
- Pharmacology
- Thrombosis
Background:
- Patients undergoing percutaneous coronary intervention (PCI) on dual antiplatelet therapy still face periprocedural ischemic events.
- Current antithrombotic drugs increase bleeding risk, highlighting an unmet need for safer, more effective treatments.
Purpose of the Study:
- To assess the efficacy and safety of Revacept, a novel lesion-directed antithrombotic agent, in patients undergoing elective PCI.
- To evaluate Revacept's ability to inhibit collagen-mediated platelet aggregation at the site of vascular injury.
Main Methods:
- A randomized, double-blind, placebo-controlled Phase II trial (ISAR-PLASTER) involving 332 patients with stable coronary artery disease undergoing elective PCI.
- Patients received either Revacept (160 mg or 80 mg) or placebo intravenously before PCI, alongside standard dual antiplatelet therapy and anticoagulation.
- Primary endpoint: composite of death or myocardial injury within 48 hours. Safety endpoint: Bleeding Academic Research Consortium class 2 or higher bleeding at 30 days.
Main Results:
- The study is designed to assess the primary composite endpoint of death or myocardial injury.
- The safety endpoint will evaluate the incidence of significant bleeding events (BARC class ≥2) within 30 days post-intervention.
- This trial represents the first assessment of Revacept's efficacy and safety in patients undergoing elective PCI.
Conclusions:
- Revacept is a novel, lesion-directed antithrombotic targeting collagen-mediated platelet adhesion.
- The ISAR-PLASTER trial will provide crucial data on the efficacy and safety profile of Revacept in the context of PCI.
- Findings may lead to improved antithrombotic strategies for patients undergoing PCI, addressing the dual challenge of ischemic events and bleeding risk.
Abstract:
Despite dual antiplatelet therapy patients undergoing percutaneous coronary intervention (PCI) continue to experience periprocedural ischemic events. In addition, all currently used antithrombotic drugs increase the bleeding risk. Thus, there is an unmet clinical need for antithrombotic strategies with improved efficacy and no increase in bleeding. Revacept is a novel, lesion-directed antithrombotic drug that does not interfere with the function of circulating platelets. This dimeric fusion protein of the extracellular domain of glycoprotein VI (the major platelet collagen receptor) and the human Fc-fragment inhibits collagen-mediated platelet adhesion and subsequent aggregation at the site of vascular injury. The randomized, double-blinded, phase II ISAR-PLASTER trial is based on extensive preclinical evaluation of Revacept and a favorable first-in-man trial. A total of 332 patients with stable coronary artery disease undergoing elective PCI will be randomized to either Revacept 160 mg, Revacept 80 mg, or placebo administered as single intravenous infusion directly before the intervention, on top of standard dual antiplatelet therapy and either heparin or bivalirudin, based on local practice and current guidelines. The primary endpoint is the composite of death or myocardial injury (defined as increase in high sensitivity troponin T ≥ 5 times the upper limit of normal) at 48 hours. The safety endpoint is bleeding of class 2 or higher according to the Bleeding Academic Research Consortium at 30 days. This phase II randomized, double blind trial will assess for the first time the efficacy and safety of Revacept-a lesion-directed inhibitor of platelet adhesion-in patients undergoing elective PCI.
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