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The Dual Antiplatelet Therapy Study (DAPT Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Abbott
Boston Scientific Corporation
Bristol-Myers Squibb
Sanofi-Synthelabo
Cordis Corporation
Eli Lilly and Company
Daiichi Sankyo Inc.
Medtronic
Information provided by:
Harvard Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT00977938
First received: September 14, 2009
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Drug: Placebo & Aspirin
Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harvard Clinical Research Institute:

Primary Outcome Measures:
  • Incidence of composite of all death, myocardial infarction (MI) and stroke (defined as MACCE) [ Time Frame: 21 months (12-33 months post-index procedure) ] [ Designated as safety issue: No ]
  • Incidence of stent thrombosis (ST) [ Time Frame: 21 months (12-33 months post-index procedure) ] [ Designated as safety issue: No ]
  • Incidence of major bleeding [ Time Frame: 21 months (12-33 months post-index procedure) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20645
Study Start Date: October 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Placebo & Aspirin
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.
 Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977938

  Show 256 Study Locations
Sponsors and Collaborators
Harvard Clinical Research Institute
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
  More Information

No publications provided by Harvard Clinical Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Laura Mauri, MD, Chief Scientific Officer, Harvard Clinical Research Institute
ClinicalTrials.gov Identifier: NCT00977938     History of Changes
Other Study ID Numbers: HCRIG080186
Study First Received: September 14, 2009
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Harvard Clinical Research Institute:
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
Prasugrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on May 23, 2013