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The ADAPTABLE Trial and Aspirin Dosing in Secondary Prevention for Patients with Coronary Artery Disease
Abigail Johnston1,2, W Schuyler Jones1,2, Adrian F Hernandez3,4
1Duke Clinical Research Institute, Duke University School of Medicine, PO Box 17969, Durham, NC, 27715, USA.
Insights
The Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) trial will compare low-dose (81 mg) versus high-dose (325 mg) aspirin in 20,000 patients with coronary artery disease to determine optimal aspirin therapy.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Coronary artery disease (CAD) is a leading cause of death in the USA.
- Aspirin therapy is recommended for secondary prevention in CAD patients.
- Optimal aspirin dosage for CAD patients remains debated due to limited evidence.
Purpose of the Study:
- To determine the optimal aspirin dosage for patients with established coronary artery disease.
- To compare the effectiveness and safety of low-dose (81 mg) versus high-dose (325 mg) aspirin.
- To provide evidence-based recommendations for aspirin therapy in CAD.
Main Methods:
- The Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) is a large, pragmatic randomized controlled trial.
- 20,000 patients with established coronary heart disease will be randomized.
- Participants will receive either 81 mg or 325 mg of aspirin daily.
Main Results:
- This section is not applicable as the study is ongoing.
- Results will be available upon completion of the trial.
- The study aims to provide definitive evidence on aspirin dosing in CAD.
Conclusions:
- The ADAPTABLE trial is expected to resolve the debate on optimal aspirin dosage for CAD.
- Findings will guide clinical practice and improve patient outcomes.
- This trial utilizes the PCORnet infrastructure for efficient, large-scale research.
Abstract:
Coronary artery disease (CAD) is the underlying cause of death in one out of seven deaths in the USA. Aspirin therapy has been proven to decrease mortality and major adverse cardiovascular events in patients with CAD. Despite a plethora of studies showing the benefit of aspirin in secondary prevention of cardiovascular events, debate remains regarding the optimal dose due to relatively small studies that had disparate results when comparing patients taking different aspirin dosages. More recently, aspirin dosing has been thoroughly studied in the CAD population with concomitant therapy (such as P2Y12 inhibitors); however, patients in these studies were not randomized to aspirin dose. No randomized controlled trial has directly measured aspirin dosages in a population of patients with established coronary artery disease. In 2015, the Patient-Centered Outcomes Research Institute (PCORI) developed a network, called PCORnet, that includes patient-powered research networks (PPRN) and clinical data research networks (CDRN). The main objective of PCORnet is to conduct widely generalizable observational studies and clinical trials (including large, pragmatic clinical trials) at a low cost. The first clinical trial, called Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE), will randomly assign 20,000 subjects with established coronary heart disease to either low dose (81 mg) or high dose (325 mg) and should be able to finally answer which dosage of aspirin is best for patients with established cardiovascular disease.
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