Phase 4
N=11,648
The Dual Antiplatelet Therapy Study (DAPT Study)
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00977938 ↗Enrolled (actual)
11,648
Serious AEs
21.3%
Results posted
Oct 2015
Primary outcome: Primary: MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT — 4.34; 5.92 percentage of patients (KM estimate) — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo & Aspirin (Drug); Clopidogrel & Aspirin, Prasugrel & Aspirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baim Institute for Clinical Research
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT |
5.62; 6.49 | — |
| PRIMARY Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT |
0.69; 1.45 | — |
| PRIMARY GUSTO Severe or Moderate Bleeding - Randomized DES ITT |
2.74; 1.88 | — |
| SECONDARY MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS |
11.37; 13.24 | <0.001 sig |
| SECONDARY Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS |
1.70; 2.61 | <0.001 sig |
| SECONDARY MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT |
5.62; 6.49 | — |
| SECONDARY Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT |
0.69; 1.45 | — |
| SECONDARY GUSTO Severe or Moderate Bleeding - Randomized DES ITT |
2.74; 1.88 | — |
| SECONDARY MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT |
4.68; 5.48 | — |
| SECONDARY Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT |
0.50; 1.11 | — |
| SECONDARY GUSTO Severe or Moderate Bleeding - Randomized BMS ITT |
2.09; 1.05 | — |
| SECONDARY MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT |
4.68; 5.48 | — |
| SECONDARY Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT |
0.50; 1.11 | — |
| SECONDARY GUSTO Severe or Moderate Bleeding - Randomized BMS ITT |
2.09; 1.05 | — |
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.
Eligibility Criteria
Inclusion Criteria (Enrollment):
- Subject is > 18 years of age.
- Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).
- Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.
- 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):
- 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):
- Index procedure stent placement with stent diameter 4.0 mm.
- Pregnant women.
- Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment.
- Current medical condition with a life expectancy of less than 3 years.
- 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.
- Subjects on warfarin or similar anticoagulant therapy.
- Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted.
- Subjects unable to give informed consent.
- Subject treated with both DES and BMS during the index procedure.
Exclusion Criteria (Randomization at 12 months):
- Pregnant women.
- Subject switched thienopyridine type or dose within 6 months prior to randomization.
- Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.
- Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
- Current medical condition with a life expectancy of less than 3 years.
- Subjects on warfarin or similar anticoagulant therapy.
Data sourced from ClinicalTrials.gov (NCT00977938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.