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.

• Conditions: Dual antiplatelet therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with either drug eluting stent (DES) or bara metal stent (BMS) placement for the treatment of coronary artery lesions.; MedDRA version: 16.1Level: LLTClassification code 10055218Term: Ischemic heart diseaseSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-015712-17-DE
• Lead Sponsor: HCRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-04
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20645

Inclusion Criteria

Enrollment inclusion criteria:
Subject must meet all of the following criteria to be eligible for treatment in the study:
1. Subject is > 18 years of age.
2. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 3 calendar days).
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.

Randomisation inclusion criteria:
Subject is 12 Month Clear”, defined as subjects who are treated with 12 months of DAPT post index procedure and who are event free (from all death, myocardial infarction, stroke, repeat coronary revascularization, stent thrombosis, and major bleeding – severe” or moderate” by GUSTO classification) during that time. During the open label portion of this study (time 0-12m post-index procedure), a subject is considered compliant with the thienopyridine therapy for the purposes of eligibility if they take between 80% and 120% of the prescribed drug in the 0-6 month and 6-12 month periods without an interruption of therapy longer than 14 days
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20645
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Enrollment exclusion criteria:
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 (>14 days) 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 where the primary endpoint has not yet been reached or the device/drug might affect major endpoint outcomes in either open label or randomized phases of the DAPT study. The subject may only be enrolled in the DAPT Study once.
6. Subjects on long-term warfarin (or similar anticoagulant) therapy who are anticipated to still be on warfarin at the time of randomization.
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.

Randomisation exclusion criteria:
1. Pregnant women.
2. Subject switched thienopyridine type or dose within 6 months prior to randomization.
NOTE: thienopyridine switching during the open label portion of this study is
discouraged.
3. Percutaneous coronary intervention or cardiac surgery between 6 weeks post
index procedure and randomization.
4. Planned surgery necessitating discontinuation of antiplatelet therapy (>14 days) 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified