Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term



Status:Enrolling by invitation
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:April 2016
End Date:June 2020

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Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness

ADAPTABLE is a pragmatic clinical trial in which 15,000 patients who are at high risk for
ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of 81
mg/day vs. 325 mg/day. Study participants will be enrolled over 36 months. Maximum follow-up
will be 40 months. The purpose of the study is to identify the optimal dose of aspirin for
secondary prevention in patients with Atherosclerotic cardiovascular disease (ASCVD). The
primary endpoint is a composite of all-cause death, hospitalization for MI, or
hospitalization for stroke. The primary safety endpoint is hospitalization for major bleeding
with an associated blood product transfusion.

In this pragmatic, patient-centered clinical trial, the investigators will compare the
effectiveness of two doses of aspirin (81 mg and 325 mg) currently in widespread use in the
United States in the secondary-prevention population of patients with established ASCVD. The
trial will use a novel format that uses existing electronic health records (EHRs), as well as
a web-based patient portal to collect patient-reported outcomes (PROs), and available patient
encounter data to supplement/support the EHR. Patients who are identified as candidates for
the trial will be directed to the electronic patient portal for the eConsent as well as an
abbreviated eligibility confirmation and randomization. One of the important aims of
ADAPTABLE is to engage patients, their healthcare providers, and trial investigators in using
the infrastructure PCORnet has developed and continues to refine. A total of 15,000 high-risk
patients with ASCVD will be randomly assigned (in an open-label fashion) in a 1:1 ratio to
instructions to use a daily aspirin dose of either 81 mg or 325 mg daily. The investigators
expect the entire sample of patients will be enrolled over 36 months, with a maximum
follow-up of 40 months.

Inclusion Criteria:

- Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior
myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least
one epicardial coronary vessel, or prior coronary revascularization procedures (either
PCI or CABG), or history of chronic heart disease, CAD, ASCVD

- Age ≥ 18 years

- No known safety concerns or side effects considered to be related to aspirin,
including

- No history of significant allergy to aspirin such as anaphylaxis, urticaria, or
significant gastrointestinal intolerances

- No history of significant GI bleed within the past 12 months

- Significant bleeding disorders that preclude the use of aspirin

- Access to the Internet. In the event that the CDRNs are notified that a cohort of
patients without internet access can be included, then patient agreement will be
obtained during the consent process to provide follow-up information by telephone
contact with the DCRI Call Center.

- Not currently treated with an oral anticoagulant - either warfarin or a novel
anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be
treated in the future with an oral anticoagulant for existing indications such as
atrial fibrillation, deep venous thrombosis, or pulmonary embolism.

- Not currently treated with ticagrelor and not planned to be treated in the future with
ticagrelor.

- Female patients who are not pregnant or nursing an infant

- Estimated risk of a major cardiovascular event (MACE) > 8% over next 3 years as
defined by the presence of at least one or more of the following enrichment factors:

- Age > 65 years

- Serum creatinine > 1.5 mg/dL

- Diabetes mellitus (Type 1 or Type 2)

- 3-vessel coronary artery disease

- Cerebrovascular disease and/or peripheral arterial disease

- Left ventricular ejection fraction (LVEF) < 50%

- Current cigarette smoker

- Chronic systolic or diastolic heart failure

- SBP > 140 (within past 12 mos)

- LDL > 130 (within past 12 mos)

Exclusion Criteria:

- There will be no exclusions for any upper age limit, comorbid conditions, or
concomitant medications other than oral anticoagulants and ticagrelor that are used at
the time of randomization, or are planned to be used during the study follow-up.

- Patients and sites interested in participating must be part of the listed health
systems collaborators.
We found this trial at
40
sites
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Baltimore, Maryland 21231
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Baltimore, MD
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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24 Sturtevant St
Orlando, Florida 32806
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Orlando, FL
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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CHapel Hill, North Carolina 27599
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CHapel Hill, NC
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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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, IL
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Columbia, Missouri 65211
(573) 882-2121
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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Columbus, Ohio 43210
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621 N Hall Street
Dallas, Texas 75226
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Dallas, Texas 75390
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Duluth, MN
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Gainesville, FL
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Marshfield, Wisconsin 54449
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Minneapolis, Minnesota 55407
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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New Orleans, Louisiana 70121
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1415 Tulane Avenue
New Orleans, Louisiana 70112
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New York, NY
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New York, New York 10467
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Orlando, FL
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Philadelphia, PA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Rochester, Minnesota 55905
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Rochester, MN
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Salt Lake City, Utah 84157
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Salt Lake City, UT
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Salt Lake City, Utah 84132
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San Antonio, TX
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Tallahassee, Florida 32301
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Tallahassee, FL
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Wilmington, Delaware 19801
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Wilmington, DE
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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