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AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

NCT03192215 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1015

Last updated 2025-04-09

Study results available
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Summary

Objectives

* Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.
* Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.

Conditions

Interventions

DRUG

Apixaban

5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).

DRUG

Aspirin

Aspirin 81 mg by mouth once daily.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Cincinnati

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Columbia University

    lead OTHER

Principal Investigators

  • Randolph S Marshall, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2023-03-31
Completion
2023-04-17
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03192215 on ClinicalTrials.gov