Status
Enrollment closed
Condition
Coronary Artery Disease
Description
A prospective, multi-center, randomized double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet (DAPT) in persons undergoing percutaneous coronary interventions (PCI) with either drug-eluting stent (DES) or bare metal stent (BMS) placement for the treatment of coronary artery lesions.
Purpose
The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect persons from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents
Phase
IV
Key Inclusion Criteria
- Person is > 18 years of age.
- Persons undergoing percutaneous intervention with stent deployment Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation
Key Exclusion Criteria
- Index procedure stent placement with stent diameter <2.25 mm or >4.0 mm.
- Pregnant women
- Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment
- Current medical condition with a life expectancy of less than 3 years
- Concurrent enrollment in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a DES or BMS other than those included as DAPT Study devices
- Persons may only be enrolled in the DAPT Study once
- Persons on warfarin or similar anticoagulant therapy
- Persons with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted
- Persons unable to give informed consent
- Persons treated with both DES and BMS during the index procedure
ClinicalTrials.gov Identifier
NCT00977938
