The Dual Antiplatelet Therapy Study (DAPT Study)



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2009
End Date:June 2014

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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

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.

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.

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.
We found this trial at
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Doylestown, Pennsylvania 18901
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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75 Francis street
Boston, Massachusetts 02115
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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860 South Columbia Road
Grand Forks, North Dakota 58201
701-780-1750
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777 Hemlock Street
Macon, Georgia 31201
(478) 633-1000
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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Ocala, Florida 34471
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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Seattle, Washington 98104
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1000 W Carson St
Torrance, California 90502
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Albuquerque, New Mexico 87106
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Ames, Iowa 50010
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Anderson, South Carolina 29621
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Asheville, North Carolina 28802
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Ashland, Kentucky 41101
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
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Atlanta, Georgia 30309
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlantis, Florida 33462
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
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Austin, Texas 78758
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Austin, Texas 78756
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Baltimore, Maryland
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
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Bangor, Maine 04401
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Barrington, Illinois 60010
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Bay City, Michigan 48708
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Boston, Massachusetts 02118
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Bridgeport, Connecticut 06610
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Bridgeport, Connecticut 06606
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Burlington, Massachusetts 01805
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
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Cedar Rapids, Iowa 52403
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Chambersburg, Pennsylvania 17201
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Charlottesville, Virginia 22903
(434) 924-0311
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Chattanooga, Tennessee 37404
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Chattanooga, Tennessee 37404
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, Illinois 60612
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2035 W Taylor St
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45220
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Columbus, Ohio 43214
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Dallas, Texas 75230
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
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Danville, Pennsylvania 17882
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Darlinghurst, New South Wales 2010
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Detroit, Michigan 48201
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3815 Highland Avenue
Downers Grove, Illinois 60515
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155 E. Brush Hill Road
Elmhurst, Illinois 60126
(331) 221-1000
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Elyria, Ohio 44035
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Fairhope, Alabama 36532
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Fargo, North Dakota 58122
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Gastonia, North Carolina 28054
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Gilbert, Arizona 85297
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Haddon Heights, New Jersey 08035
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Hamilton, New Jersey 08690
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Harrisburg, Pennsylvania 17101
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Harrisonburg, Virginia 22801
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Hattiesburg, Mississippi 39401
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Hawthorne, New Jersey 07506
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High Point, North Carolina 27262
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Hyannis, Massachusetts 02601
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32207
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Johnstown, Pennsylvania 15905
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Jonesboro, Arkansas 72401
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1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
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Kansas City, Missouri 64132
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La Jolla, California 92037
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Lakeland, Florida 33805
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Lauderdale Lakes, Florida 33313
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Lincoln, Nebraska 68526
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Little Rock, Arkansas 72211
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Liverpool, New York 13088
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Lynchburg, Virginia 24501
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Manchester, New Hampshire 03102
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
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McKinney, Texas 75069
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McKinney, Texas 75069
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Melbourne, Florida 32901
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8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
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Midwest City, Oklahoma 73110
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
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259 1st St
Mineola, New York 11501
(516) 663-0333
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Mokena, Illinois 60448
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
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