REGULATE - REG1 Anticoagulation vs. Bivalirudin in PCI
Research type
Research Study
Full title
A RANDOMISED, OPEN-LABEL, MULTI-CENTRE, ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY AND SAFETY OF THE REG1 ANTICOAGULATION SYSTEM COMPARED TO BIVALIRUDIN IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION
IRAS ID
133148
Contact name
Rodney Stables
Contact email
Sponsor organisation
Regado Biosciences, Inc.
Eudract number
2013-001384-23
Clinicaltrials.gov Identifier
Research summary
Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the narrowed coronary arteries of the heart found in coronary heart disease.
Currently, the development aim for both systemic anticoagulant agents (substance that stops blood clotting during the procedure) and continued anti-platelet therapy (drugs that reduce the risk of subsequent clotting) is to establish a balance between effectiveness - by reducing the risk of ischaemic complications (caused by clot formation) - and safety by minimising the risk of bleeding.
Cardiovascular clinicians have generally been willing to trade-off an increased risk of bleeding when a drug can reduce ischaemic complications (lack of blood flow; usually clot related). However, recent data suggests that bleeding events have a significant impact on the outcome and cost of treatment in these patients. Despite the continued development of novel antithrombotics, there is a need for safer anticoagulants.
The study drug (REG1), is an anticoagulation system which includes a drug called pegnivacogin and an active control agent called anivamersen, which is specific to pegnivacogin. Pegnivacogin is an anticoagulation agent with long-term duration of action (~30 hours) that can reliably achieve high levels of anticoagulation at relatively low doses of drug, used in combination with the second agent anivamersen, which is capable of specifically binding to and neutralising the pegnivacogin.
Such a “drug and active-control” combination can ensure a durable and easy to use anticoagulant agent with predictable and safe neutralisation of the anticoagulant activity of the agent.
This phase III study is being sponsored by Regado Biosciences, Inc. to see how effective the REG1 Anticoagulation System is when compared to bivalrudin in preventing thrombotic and bleeding complications in patients who are undergoing percutaneous coronary intervention.
It is expected that approximately 13,200 patients will take part in the study at about 500-600 centres around the world including the United States, Canada and countries in Europe.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0762
Date of REC Opinion
28 Nov 2013
REC opinion
Further Information Favourable Opinion