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COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2

NCT06396299 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2025-05-09

No results posted yet for this study

Summary

Atrial fibrillation (AF) is a leading cause of cardiovascular mortality and morbidity. Asian patients with AF have a higher rate of major bleeding including intracranial hemorrhage (ICH) compared to non-Asians. Non-vitamin K antagonist oral anticoagulants (NOACs) are the safer drugs compared to warfarin due to a lower rate of ICH, but the rate of NOACs use in many Asian AF is much lower than non-Asian countries due to economic concerns. The purpose of the COhort of antithrOmbotic use and cLinical outcomes in patients with Atrial Fibrillation (COOL-AF) Phase 2 registry is to determine the changes in antithrombotic patterns and the impact on clinical outcomes.

The COOL-AF Phase 2 study is a prospective observational multicenter study of patients with known or newly diagnosed non-valvular AF in Thailand. The aim is a sample size is 3680 patients from 33 centers within a 2-years enrollment timeline. Patients will be follow-up every 6 months until 3 years. The study outcomes were death, ischemic stroke/systemic embolism, major bleeding, myocardial infarction, heart failure, and quality of life.

Conditions

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • Health Systems Research Institute,Thailand

    collaborator OTHER_GOV

  • The Heart Association of Thailand

    collaborator UNKNOWN

  • Mahidol University

    lead OTHER

Principal Investigators

  • Rungroj Krittayaphong, MD,FESC,FACC · Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol university

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-02
Primary Completion
2029-06-01
Completion
2030-06-01

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

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 NCT06396299 on ClinicalTrials.gov