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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)
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
Secondary ID [1] 0 0
HCRIG080186
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
Timepoint [1] 0 0
18 months (12-30 months post-index procedure)
Primary outcome [2] 0 0
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
Timepoint [2] 0 0
18 months (12-30 months post-index procedure)
Primary outcome [3] 0 0
GUSTO Severe or Moderate Bleeding - Randomized DES ITT
Timepoint [3] 0 0
18 months (12-30 months post-index procedure)
Secondary outcome [1] 0 0
MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS
Timepoint [1] 0 0
33 months (0-33 months post-index procedure)
Secondary outcome [2] 0 0
Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS
Timepoint [2] 0 0
33 months (0-33 months post-index procedure)
Secondary outcome [3] 0 0
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
Timepoint [3] 0 0
21 months (12-33 months post-index procedure)
Secondary outcome [4] 0 0
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
Timepoint [4] 0 0
21 months (12-33 months post-index procedure)
Secondary outcome [5] 0 0
GUSTO Severe or Moderate Bleeding - Randomized DES ITT
Timepoint [5] 0 0
21 months (12-33 months post-index procedure)
Secondary outcome [6] 0 0
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
Timepoint [6] 0 0
18 months (12-30 months post-index procedure)
Secondary outcome [7] 0 0
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
Timepoint [7] 0 0
18 months (12-30 months post-index procedure)
Secondary outcome [8] 0 0
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
Timepoint [8] 0 0
18 months (12-30 months post-index procedure)
Secondary outcome [9] 0 0
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
Timepoint [9] 0 0
21 months (12-33 months post-index procedure)
Secondary outcome [10] 0 0
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
Timepoint [10] 0 0
21 months (12-33 months post-index procedure)
Secondary outcome [11] 0 0
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
Timepoint [11] 0 0
21 months (12-33 months post-index procedure)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
25682
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
St. Vincents Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Prince of Wales Eastern Heart - Randwick
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [5] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [6] 0 0
The Mount Hospital - Nedlands
Recruitment hospital [7] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [8] 0 0
Monash Heart - Clayton
Recruitment hospital [9] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Prahran
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment outside Australia
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Alabama
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District of Columbia
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Georgia
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Newcastle
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Plymouth

Funding & Sponsors
Primary sponsor type
Other
Name
Baim Institute for Clinical Research
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Abbott
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Boston Scientific Corporation
Address [2] 0 0
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Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Bristol-Myers Squibb
Address [3] 0 0
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Name [4] 0 0
Sanofi-Synthelabo
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Cordis Corporation
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Commercial sector/Industry
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Eli Lilly and Company
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Commercial sector/Industry
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Daiichi Sankyo
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Other collaborator category [8] 0 0
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Medtronic
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00977938
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Laura Mauri, MD, MSc
Address 0 0
Brigham and Women's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries