The Dual Antiplatelet Therapy Study (DAPT Study)

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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 patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baim Institute for Clinical Research; Harvard Clinical Research Institute
• Collaborators: Abbott; Boston Scientific Corporation; Bristol-Myers Squibb; Cordis Corporation; Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.; Eli Lilly and Company; Medtronic; Sanofi-Synthelabo
• Treatments: Aspirin; Clopidogrel; Prasugrel Hydrochloride

Criteria

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.