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The Dual Antiplatelet Therapy Study (DAPT Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00977938
Recruitment Status : Completed
First Posted : September 16, 2009
Results First Posted : October 22, 2015
Last Update Posted : June 9, 2017
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE September 14, 2009
First Posted Date  ICMJE September 16, 2009
Results First Submitted Date  ICMJE September 18, 2015
Results First Posted Date  ICMJE October 22, 2015
Last Update Posted Date June 9, 2017
Study Start Date  ICMJE October 2009
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2009)
  • Incidence of composite of all death, myocardial infarction (MI) and stroke (defined as MACCE) [ Time Frame: 21 months (12-33 months post-index procedure) ]
  • Incidence of stent thrombosis (ST) [ Time Frame: 21 months (12-33 months post-index procedure) ]
  • Incidence of major bleeding [ Time Frame: 21 months (12-33 months post-index procedure) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Dual Antiplatelet Therapy Study (DAPT Study)
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: Placebo & Aspirin
  • Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2015)
25682
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2009)
20645
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Czechia,   France,   Germany,   Hungary,   New Zealand,   Poland,   Romania,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00977938
Other Study ID Numbers  ICMJE HCRIG080186
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baim Institute for Clinical Research
Study Sponsor  ICMJE Baim Institute for Clinical Research
Collaborators  ICMJE
  • Abbott
  • Boston Scientific Corporation
  • Bristol-Myers Squibb
  • Sanofi-Synthelabo
  • Cordis Corporation
  • Eli Lilly and Company
  • Daiichi Sankyo, Inc.
  • Medtronic
Investigators  ICMJE
Principal Investigator: Laura Mauri, MD, MSc Brigham and Women's Hospital
Principal Investigator: Dean Kereiakes, MD, FACC Christ Hospital Heart and Vascular Center
PRS Account Baim Institute for Clinical Research
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP