The Dual Antiplatelet Therapy Study (DAPT Study)
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| ClinicalTrials.gov Identifier: NCT00977938 |
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Recruitment Status :
Completed
First Posted : September 16, 2009
Results First Posted : October 22, 2015
Last Update Posted : June 9, 2017
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Sponsor:
Baim Institute for Clinical Research
Collaborators:
Abbott
Boston Scientific Corporation
Bristol-Myers Squibb
Sanofi-Synthelabo
Cordis Corporation
Eli Lilly and Company
Daiichi Sankyo, Inc.
Medtronic
Information provided by (Responsible Party):
Baim Institute for Clinical Research
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease | Drug: Placebo & Aspirin Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 25682 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | October 2009 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | June 2014 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 12m DAPT Study Arm
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.
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Drug: Placebo & Aspirin |
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Active Comparator: 30m DAPT Study Arm
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.
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Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin |
Primary Outcome Measures :
- MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT [ Time Frame: 18 months (12-30 months post-index procedure) ]The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure.
- Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT [ Time Frame: 18 months (12-30 months post-index procedure) ]The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions.
- GUSTO Severe or Moderate Bleeding - Randomized DES ITT [ Time Frame: 18 months (12-30 months post-index procedure) ]The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
Secondary Outcome Measures :
- MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS [ Time Frame: 33 months (0-33 months post-index procedure) ]Secondary powered endpoint
- Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS [ Time Frame: 33 months (0-33 months post-index procedure) ]Secondary powered endpoint
- MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT [ Time Frame: 21 months (12-33 months post-index procedure) ]
- Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT [ Time Frame: 21 months (12-33 months post-index procedure) ]ST was assessed according to the Academic Research Consortium (ARC) definitions.
- GUSTO Severe or Moderate Bleeding - Randomized DES ITT [ Time Frame: 21 months (12-33 months post-index procedure) ]Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
- MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT [ Time Frame: 18 months (12-30 months post-index procedure) ]
- Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT [ Time Frame: 18 months (12-30 months post-index procedure) ]ST was assessed according to the Academic Research Consortium (ARC) definitions.
- GUSTO Severe or Moderate Bleeding - Randomized BMS ITT [ Time Frame: 18 months (12-30 months post-index procedure) ]Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
- MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT [ Time Frame: 21 months (12-33 months post-index procedure) ]
- Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT [ Time Frame: 21 months (12-33 months post-index procedure) ]ST was assessed according to the Academic Research Consortium (ARC) definitions.
- GUSTO Severe or Moderate Bleeding - Randomized BMS ITT [ Time Frame: 21 months (12-33 months post-index procedure) ]Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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):
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):
- Index procedure stent placement with stent diameter <2.25 mm or >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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977938
Locations
Show 256 study locations
Sponsors and Collaborators
Baim Institute for Clinical Research
Abbott
Boston Scientific Corporation
Bristol-Myers Squibb
Sanofi-Synthelabo
Cordis Corporation
Eli Lilly and Company
Daiichi Sankyo, Inc.
Medtronic
Investigators
| Principal Investigator: | Laura Mauri, MD, MSc | Brigham and Women's Hospital | |
| Principal Investigator: | Dean Kereiakes, MD, FACC | Christ Hospital Heart and Vascular Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Baim Institute for Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00977938 |
| Other Study ID Numbers: |
HCRIG080186 |
| First Posted: | September 16, 2009 Key Record Dates |
| Results First Posted: | October 22, 2015 |
| Last Update Posted: | June 9, 2017 |
| Last Verified: | May 2017 |
Keywords provided by Baim Institute for Clinical Research:
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Acute Coronary Syndrome Adverse event Antiplatelet therapy Sirolimus Everolimus Paclitaxel Zotarolimus Bare Metal Stent Drug Eluting Stent Clinical Events Committee Dual antiplatelet therapy |
Harvard Clinical Research Institute Major Adverse Cardiac and Cerebral Event Major Bleeding Myocardial infarction Myocardial ischemia Percutaneous coronary intervention Stent placement Stent Thrombosis Thienopyridine Clopidogrel Prasugrel |
Additional relevant MeSH terms:
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Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Clopidogrel Prasugrel Hydrochloride Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents |