Revacept/CS/02
Research type
Research Study
Full title
REVACEPT, AN INHIBITOR OF PLATELET ADHESION IN SYMPTOMATIC CAROTID STENOSIS: A PHASE II, MULTICENTRE; RANDOMISED, DOSE-FINDING, DOUBLE-BLIND AND PLACEBO-CONTROLLED SUPERIORITY STUDY WITH PARALLEL GROUPS
IRAS ID
137999
Contact name
Ian Loftus
Contact email
Sponsor organisation
advanceCOR GmbH
Eudract number
2011-001006-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
This is a double-blind, placebo-controlled, randomised phase II study of a novel inhibitor of platelet 'stickiness' or aggregation, called Revacept. Revacept is being investigated for the prevention of stroke in patients with symptomatic carotid artery narrowing. In some patients with carotid narrowing, platelets in the blood adhere to the site of narrowing causing clot formation (thrombus) and further risk of transient ischaemic attacks and stroke. In the first few weeks after the neurological event, there is a high risk for a second, potentially more serious, event including stroke.
Results obtained in animal models indicate that Revacept is effective at preventing thrombus formation at the sites of carotid artery narrowing, thereby reducing the risk for recurrence of a neurological event. A Phase I clinical trial in healthy volunteers demonstrated that Revacept was well tolerated, with no drug-related adverse events observed. This Phase II study aims to assess the efficacy and safety of various doses of Revacept in patients with symptomatic carotid narrowing.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
13/EE/0326
Date of REC Opinion
29 Oct 2013
REC opinion
Further Information Favourable Opinion