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

NCT ID: NCT02697916

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15076 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-06-30

Brief Summary

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 38 months. Maximum follow-up will be 50 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.

Detailed Description

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 38 months, with a maximum follow-up of 50 months.

Conditions

Atherosclerotic Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ASA 81mg

aspirin 81mg

Group Type: ACTIVE_COMPARATOR

aspirin

Intervention Type: DRUG

81mg of aspirin daily vs. 325mg of aspirin daily

ASA 325mg

aspirin 325mg

Group Type: ACTIVE_COMPARATOR

aspirin

Intervention Type: DRUG

81mg of aspirin daily vs. 325mg of aspirin daily

Interventions

aspirin

81mg of aspirin daily vs. 325mg of aspirin daily

Intervention Type: DRUG

Other Intervention Names

ASA

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Medidata Solutions

INDUSTRY

Sponsor Role: collaborator

Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)

OTHER

Sponsor Role: collaborator

Greater Plains Collaborative Clinical Data Research Network

OTHER

Sponsor Role: collaborator

Mid-South Clinical Data Research Network

OTHER

Sponsor Role: collaborator

Research Action for Health Network (REACHnet)

OTHER

Sponsor Role: collaborator

The Patient-Oriented Scalable National Network for Effectiveness Research

OTHER

Sponsor Role: collaborator

PaTH Clinical Data Research Network

OTHER

Sponsor Role: collaborator

New York City Clinical Data Research Network

OTHER

Sponsor Role: collaborator

The Health eHeart Alliance

OTHER

Sponsor Role: collaborator

OneFlorida Clinical Data Research Network

NETWORK

Sponsor Role: collaborator

HealthCore-Anthem Research Network

OTHER

Sponsor Role: collaborator

Humana Inc.

INDUSTRY

Sponsor Role: collaborator

The Patient-Centered Network of Learning Health Systems

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William S. Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Adrian F. Hernandez, MD MHS FAHA

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Locations

UCLA Medical Center

Los Angeles, California, United States

HealthCore

Wilmington, Delaware, United States

University of Florida Cardiology - Springhill

Gainesville, Florida, United States

Florida Hospital

Orlando, Florida, United States

Orlando Health

Orlando, Florida, United States

Bond Community Health Center

Tallahassee, Florida, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Ochsner Health System

New Orleans, Louisiana, United States

Tulane University Heart & Vascular Institute

New Orleans, Louisiana, United States

Johns Hopkins Medical Center

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Essentia Health St. Mary's Medical Center

Duluth, Minnesota, United States

Allina Health

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Missouri

Columbia, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

New York University School of Medicine

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Weill Cornell Medicine of Cornell University

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Ohio State Univerity

Columbus, Ohio, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

Baylor Scott and White Heart and Vascular Hospital

Dallas, Texas, United States

University of Texas-Southwestern

Dallas, Texas, United States

University of Texas Health Sciences Center at San Antonio

San Antonio, Texas, United States

Intermountain Medical Center

Salt Lake City, Utah, United States

University of Utah Hospitals and Clinics

Salt Lake City, Utah, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://theaspirinstudy.org/

ADAPTABLE public website

Other Identifiers

Pro00068525

Identifier Type: -

Identifier Source: org_study_id