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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00977938
Registration number
NCT00977938
Ethics application status
Date submitted
14/09/2009
Date registered
16/09/2009
Date last updated
9/06/2017
Titles & IDs
Public title
The Dual Antiplatelet Therapy Study (DAPT Study)
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Scientific 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
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Secondary ID [1]
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HCRIG080186
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo & Aspirin
Treatment: Drugs - Clopidogrel & Aspirin, Prasugrel & Aspirin
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.
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.
Treatment: Drugs: Placebo & Aspirin
Treatment: Drugs: Clopidogrel & Aspirin, Prasugrel & Aspirin
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
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Assessment method [1]
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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.
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Timepoint [1]
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18 months (12-30 months post-index procedure)
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Primary outcome [2]
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Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
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Assessment method [2]
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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.
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Timepoint [2]
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18 months (12-30 months post-index procedure)
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Primary outcome [3]
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GUSTO Severe or Moderate Bleeding - Randomized DES ITT
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Assessment method [3]
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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.
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Timepoint [3]
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18 months (12-30 months post-index procedure)
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Secondary outcome [1]
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MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS
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Assessment method [1]
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Secondary powered endpoint
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Timepoint [1]
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33 months (0-33 months post-index procedure)
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Secondary outcome [2]
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Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS
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Assessment method [2]
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Secondary powered endpoint
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Timepoint [2]
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33 months (0-33 months post-index procedure)
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Secondary outcome [3]
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MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
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Assessment method [3]
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Timepoint [3]
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21 months (12-33 months post-index procedure)
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Secondary outcome [4]
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Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
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Assessment method [4]
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ST was assessed according to the Academic Research Consortium (ARC) definitions.
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Timepoint [4]
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21 months (12-33 months post-index procedure)
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Secondary outcome [5]
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GUSTO Severe or Moderate Bleeding - Randomized DES ITT
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Assessment method [5]
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Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
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Timepoint [5]
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21 months (12-33 months post-index procedure)
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Secondary outcome [6]
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MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
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Assessment method [6]
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0
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Timepoint [6]
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18 months (12-30 months post-index procedure)
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Secondary outcome [7]
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Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
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Assessment method [7]
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ST was assessed according to the Academic Research Consortium (ARC) definitions.
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Timepoint [7]
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18 months (12-30 months post-index procedure)
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Secondary outcome [8]
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GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
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Assessment method [8]
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Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
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Timepoint [8]
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18 months (12-30 months post-index procedure)
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Secondary outcome [9]
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MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
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Assessment method [9]
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0
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Timepoint [9]
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21 months (12-33 months post-index procedure)
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Secondary outcome [10]
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Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
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Assessment method [10]
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ST was assessed according to the Academic Research Consortium (ARC) definitions.
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Timepoint [10]
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21 months (12-33 months post-index procedure)
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Secondary outcome [11]
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GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
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Assessment method [11]
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Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
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Timepoint [11]
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21 months (12-33 months post-index procedure)
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2014
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Sample size
Target
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Accrual to date
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Final
25682
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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St. Vincents Hospital Sydney - Darlinghurst
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Recruitment hospital [2]
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Prince of Wales Eastern Heart - Randwick
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Royal Adelaide Hospital - Adelaide
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The Alfred Hospital - Prahran
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Fremantle Hospital - Fremantle
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The Mount Hospital - Nedlands
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Royal Perth Hospital - Perth
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Monash Heart - Clayton
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Recruitment hospital [9]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3004 - Prahran
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6160 - Fremantle
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment postcode(s) [7]
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6000 - Perth
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Recruitment postcode(s) [8]
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3168 - Clayton
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Recruitment postcode(s) [9]
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3065 - Fitzroy
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Recruitment outside Australia
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Alabama
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District of Columbia
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Florida
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Georgia
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Illinois
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United Kingdom
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Newcastle
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United Kingdom
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Plymouth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Baim Institute for Clinical Research
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Abbott
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Boston Scientific Corporation
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Bristol-Myers Squibb
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Sanofi-Synthelabo
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Cordis Corporation
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Eli Lilly and Company
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Daiichi Sankyo
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Medtronic
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00977938
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Public notes
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Contacts
Principal investigator
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Laura Mauri, MD, MSc
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Brigham and Women's Hospital
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00977938
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