The Dual Antiplatelet Therapy Study (DAPT Study) - Full Text View

Sponsor:	Harvard Clinical Research Institute
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

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Coronary Artery Disease Heart Attack

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate Prasugrel

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
12m DAPT Study Arm: Placebo 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 18 months of placebo treatment in addition to aspirin.	Drug: Placebo & Aspirin
30m DAPT Study Arm: 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.	Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin

Arms

Assigned Interventions

12m DAPT Study Arm: Placebo 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 18 months of placebo treatment in addition to aspirin.

Drug: Placebo & Aspirin

30m DAPT Study Arm: 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.

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):

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977938

Contacts

Contact: Ann Marie Mercando, RN, MHA	617.632.1598	ann.marie.mercando@hcri.harvard.edu
Contact: Suzanne Morin	617.632.1370	suzanne.morin@hcri.harvard.edu

Show 23 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

Responsible Party:	Harvard Clinical Research Institute ( Laura Mauri, MD, Chief Scientific Officer )
Study ID Numbers:	HCRIG080186
Study First Received:	September 14, 2009
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00977938 History of Changes
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:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Arteriosclerosis
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics
Arterial Occlusive Diseases

Heart Diseases
Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Coronary Disease
Analgesics, Non-Narcotic
Clopidogrel
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 20, 2009