REVACEPT, A NOVEL INHIBITOR OF PLATELET ADHESION IN PATIENTS WITHSTABLE CORONARY ARTERY DISEASE UNDERGOING ELECTIVEPERCUTANEOUS CORONARY INTERVENTIONS: A PHASE II, MULTICENTRE,RANDOMISED, DOSE-FINDING, DOUBLE-BLIND AND PLACEBO-CONTROLLEDSTUDY

15/10/2018 to 31/12/2021

Treatment Regime:
Patients with coronary artery disease scheduled for elective PCI receive periprocedural antithrombotic therapy composed of clopidogrel, ASA and heparin (or bivalirudin) based on local practice and current guidelines. Revacept or placebo infusion will be started as soon as possible after the decision to perform PCI but prior to the start of the PCI procedure (guidewire
passage).
OBJECTIVES
The main objective is to evaluate the efficacy and safety of treatment with 2 doses (80 and 160 mg) of Revacept versus placebo. Periprocedural antithrombotic therapy composed of clopidogrel, ASA and heparin (or bivalirudin) will be administered based on local practice and current guidelines. The treatment effect will be assessed using the following endpoints: • Primary endpoint of the study
A composite endpoint of death or myocardial injury (defined as increase in cardiac biomarker – high sensitivity cardiac troponin of at least 5 times the upper limit of norm (ULN) within 48 hours from randomisation).