A prospective, multi-center, randomized, double-blind trial to assess theeffectiveness and safety of 12 versus 30 months of dual antiplatelet therapy(DAPT) in subjects undergoing percutaneous coronary intervention (PCI) witheither drug-eluting stent (DES) or bare metal stent (BMS) placement for thetreatment of coronary artery lesions. - DAPT Study

• 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: 12.1Level: LLTClassification code 10051592Term: Acute coronary syndrome

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-04
• Last Update Posted: 7 October 2014

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 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.

Randomisation inclusion criteria:

Subject is 12 Month Clear”. Defined as subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding –severe” or moderate” by GUSTO classification, and ST 12 months after stent implantation and who are compliant with 12 months of DAPT following stent implantation.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Enrollment exclusion criteria:

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.

Randomisation exclusion criteria:

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 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