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

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.

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

DRUG

aspirin

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

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Medidata Solutions

  collaborator INDUSTRY

• Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)

  collaborator OTHER

• Greater Plains Collaborative Clinical Data Research Network

  collaborator OTHER

• Mid-South Clinical Data Research Network

  collaborator OTHER

• Research Action for Health Network (REACHnet)

  collaborator OTHER

• The Patient-Oriented Scalable National Network for Effectiveness Research

  collaborator OTHER

• PaTH Clinical Data Research Network

  collaborator OTHER

• New York City Clinical Data Research Network

  collaborator OTHER

• The Health eHeart Alliance

  collaborator OTHER

• OneFlorida Clinical Data Research Network

  collaborator NETWORK

• HealthCore-Anthem Research Network

  collaborator OTHER

• Humana Inc.

  collaborator INDUSTRY

• The Patient-Centered Network of Learning Health Systems

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• William S. Jones, MD · Duke Clinical Research Institute

• Adrian F. Hernandez, MD MHS FAHA · Duke Clinical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2020-06-30

Completion

2020-06-30

Countries

• United States

Study Locations