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Trial aims to find optimal aspirin dose for secondary prevention of CVD
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The Patient-Centered Outcomes Research Institute announced that it has awarded $14 million to fund a clinical trial of up to 20,000 patients with heart disease to determine optimal aspirin dose for secondary prevention of CVD.
The ADAPTABLE trial will be the first conducted through the National Patient-Centered Clinical Research Network (PCORnet).
Up to 20,000 patients with MI or obstructive CAD will be randomly assigned aspirin 81 mg/day or 325 mg/day. Outcomes will include death, hospitalization for MI or stroke, and gastrointestinal bleeding. Maximum follow-up will be 30 months.
Analysis will include stratification of patients by sex, age, race/ethnicity, diabetes status, chronic kidney disease status and Internet user status.
According to the announcement, the study is a pragmatic randomized clinical trial, which means that it will:
- use existing data sources to gather baseline characteristics;
- use a combination of existing data and patient-reported outcomes at follow-up;
- have an Internet portal to allow patients and physicians to collect and monitor data;
- collect patient-reported outcomes; and
- have streamlined administration, including centralization of institutional review board functions and contracts, electronic consent forms, and use of electronic health record and claims data.
Mechanistic studies, including genetic testing and platelet physiology studies, also may be performed.
Matthew T. Roe, MD, MHS, from Duke University Medical Center and Duke Clinical Research Institute, will serve as principal investigator.