HCRI DAPT Study
Research type
Research Study
Full title
A prospective, multi-center, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with either drug-eluting stent (DES) or bare metal stent (BMS) placement for the treatment of coronary artery lesions.
IRAS ID
33904
Contact name
Anthony Gershlick
Sponsor organisation
HCRI
Eudract number
2009-015712-17
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to collect information about how dual anti-platelet therapy (blood thinning medicines) following a percutaneous coronary intervention (PCI) keeps patients free from death, heart attack, stroke, bleeding, blood clots and another PCI. Male or female patients = 18 years of age with ischemic heart disease who are due to undergo a PCI are eligible for this study. Following the PCI, patients in this study will be followed up for up to 33 months. Those who have not had a heart attack, stroke, bleeding, blood clots or another PCI, 12 months after their PCI will be randomly placed by chance (like a flip of the coin) into one of two groups to receive either placebo (inactive substance) or the antiplatelet medicine (clopidogrel or prasugrel for an additional 18 months and will also continue to take aspirin during those 18 months. 20, 645 people will be enrolled in this study at approximately 219 sites in the United States and outside the US.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
10/H0405/23
Date of REC Opinion
16 Mar 2010
REC opinion
Favourable Opinion