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

Atherosclerotic Cardiovascular Disease Clinical Trial

— ADAPTABLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697916
• Other study ID #: Pro00068525
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15076
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• aspirin
81mg of aspirin daily vs. 325mg of aspirin daily

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins Medical Center	Baltimore	Maryland
United States	UNC Chapel Hill	Chapel Hill	North Carolina
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	University of Missouri	Columbia	Missouri
United States	Ohio State Univerity	Columbus	Ohio
United States	Baylor Scott and White Heart and Vascular Hospital	Dallas	Texas
United States	University of Texas-Southwestern	Dallas	Texas
United States	Essentia Health St. Mary's Medical Center	Duluth	Minnesota
United States	Duke University	Durham	North Carolina
United States	University of Florida Cardiology - Springhill	Gainesville	Florida
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania
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	UCLA Medical Center	Los Angeles	California
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Allina Health	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Ochsner Health System	New Orleans	Louisiana
United States	Tulane University Heart & Vascular Institute	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Montefiore Medical Center	New York	New York
United States	New York University School of Medicine	New York	New York
United States	Weill Cornell Medicine of Cornell University	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Florida Hospital	Orlando	Florida
United States	Orlando Health	Orlando	Florida
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	University of Utah Hospitals and Clinics	Salt Lake City	Utah
United States	University of Texas Health Sciences Center at San Antonio	San Antonio	Texas
United States	Bond Community Health Center	Tallahassee	Florida
United States	HealthCore	Wilmington	Delaware
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (15)

Lead Sponsor

Collaborator

Duke University

Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN), Greater Plains Collaborative Clinical Data Research Network, Health eHeart Patient Powered Network, HealthCore-Anthem Research Network, Humana-HUMnet, Mid-South Clinical Data Research Network, Mytrus, New York City Clinical Data Research Network, OneFlorida Clinical Data Research Network, PaTH Clinical Data Research Network, Patient-Centered Outcomes Research Institute, Patient-Centered Scalable National Network for Effectiveness Research, Research Action for Health Network (REACHnet), The Patient-Centered Network of Learning Health Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Experiencing Hospitalization for Major Bleeding Complications With an Associated Blood Product Transfusion		Time of randomization through study completion, approximately 4 years
Primary	Number of Participants Experiencing All-cause Death, Hospitalization for Nonfatal MI, or Hospitalization for Nonfatal Stroke in High-risk Patients With a History of MI or Documented Atherosclerotic Cardiovascular Disease (ASCVD)		Time of randomization through study completion, approximately 4 years
Secondary	Number of Participants Experiencing All-cause Death		Time of randomization through study completion, approximately 4 years
Secondary	Number of Participants Experiencing Hospitalization for Nonfatal MI		Time of randomization through study completion, approximately 4 years
Secondary	Number of Participants Experiencing Hospitalization for Nonfatal Stroke		Time of randomization through study completion, approximately 4 years
Secondary	Number of Participants Requiring Coronary Revascularization Procedures (Percutaneous Coronary Intervention [PCI] or Coronary Artery Bypass Grafting [CABG])		Time of randomization through study completion, approximately 4 years
Secondary	Quality of Life and Functional Status, as Measured on a 5-point Scale	Quality of life measures are based on an ordinal scale from 1-5, where 1 corresponds to the best outcome and 5 to the worst. Model-based mean score estimates are obtained from mixed models of each quality of life measure.	2 years

External Links

•   ADAPTABLE public website