Completed

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

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What is being tested

Placebo & Aspirin

+ Clopidogrel & Aspirin, Prasugrel & Aspirin

Drug
Who is being recruted

Arterial Occlusive Diseases+12

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: October 2009
See protocol details

Summary

Principal SponsorBaim Institute for Clinical Research
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2009

Actual date on which the first participant was enrolled.

Subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention (PCI) with stent placement and no contraindications to prolonged dual antiplatelet therapy are eligible to be enrolled in the study. All enrolled subjects will undergo PCI with stent placement. All enrolled subjects will be treated with either an FDA-approved drug eluting stent(s) (DES) or an FDA-approved bare metal stent(s) (BMS) (per their respective Instructions for Use) and assigned to 12 months of open label FDA-approved thienopyridine treatment in addition to aspirin. Operators will select the thienopyridine according to the package insert. Thienopyridine treatment dose will be according to the standard of practice and prescribing information for the selected medication. Aspirin treatment will be 75-325 mg for the first 6 months after the procedure and 75-162 mg subsequently, to be continued indefinitely. All DES or BMS subjects who are treated with 12 months of dual antiplatelet therapy post index procedure and who are event free per protocol will be eligible for randomization to either placebo (12 m DAPT Study arm) or an additional 18 months of thienopyridine treatment (30 m DAPT Study arm). Both arms will continue aspirin therapy. Up to four (4) separate post-market approval studies will be allowed to incorporate the randomized design of the DAPT Study for a subset of subjects who may then be contributed for the DAPT Study analyses.

Official TitleA 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
NCT00977938
Principal SponsorBaim Institute for Clinical Research
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25682 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesInfarctionIschemiaMyocardial InfarctionNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaAcute Coronary Syndrome

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

Group II

Active Comparator
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine treatment in addition to aspirin.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 256 locations

Suspended

Thomas Hospital

Fairhope, United StatesOpen Thomas Hospital in Google Maps
Suspended

Mercy Gilbert Medical Center

Gilbert, United States
Suspended

Heart & Vascular Center of Arizona

Phoenix, United States
Suspended

Scottsdale Health Care

Scottsdale, United States
Completed256 Study Centers