A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions

Date de début de l'étude : 1 octobre 2009

Inclusion Criteria (Enrollment): 1. Subject is \> 18 years of age. 2. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours). 3. Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation. 4. The subject has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form". The informed consent will be valid for the duration of the trial or until the subject withdraws. Inclusion Criterion (Randomization at 12 months): 1\. Subject, at 12 months, is free from death, MI, stroke, repeat coronary revascularization, major bleeding, and stent thrombosis and has been compliant with dual antiplatelet therapy following stent implantation. Exclusion Criteria (Enrollment): 1. Index procedure stent placement with stent diameter \<2.25 mm or \>4.0 mm. 2. Pregnant women. 3. Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment. 4. Current medical condition with a life expectancy of less than 3 years. 5. 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. The subject may only be enrolled in the DAPT Study once. 6. Subjects on warfarin or similar anticoagulant therapy. 7. Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted. 8. Subjects unable to give informed consent. 9. Subject treated with both DES and BMS during the index procedure. Exclusion Criteria (Randomization at 12 months): 1. Pregnant women. 2. Subject switched thienopyridine type or dose within 6 months prior to randomization. 3. Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization. 4. Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization. 5. Current medical condition with a life expectancy of less than 3 years. 6. Subjects on warfarin or similar anticoagulant therapy.