Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept

Phase 2 Completed 334 enrolled German Heart Center Munich AdvanceCor GmbH · collab Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) · collab German Federal Ministry of Education and Research · collab Technical University of Munich · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2017-11-20
Primary completion: 2020-02-29
Completion: 2020-03-26

Outcome

Missed primary endpoint

paper The primary end point showed no significant differences between the revacept and placebo groups: 24.4%, 25.0%, and 23.3% PMID 33787834 ↗

paper Revacept did not reduce myocardial injury in patients with stable ischemic heart disease undergoing percutaneous coronary intervention. PMID 33787834 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Revacept	Protein / enzyme biologic	80 mg	Intravenous
Subject	Revacept	Protein / enzyme biologic	160 mg	Intravenous