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

May 7, 2025 updated by: Rungroj Krittayaphong, Mahidol University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Not yet recruiting
        • Rajavithi Hospital
        • Contact:
      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Meddcine Siriraj Hospital, Mahidol University
        • Contact:
      • Bangkok, Thailand
        • Recruiting
        • Bhumibol Adulyadej Hospital
        • Contact:
      • Bangkok, Thailand
        • Recruiting
        • Charoen Krung Pracha Rak Hospital
        • Contact:
      • Bangkok, Thailand
        • Recruiting
        • Faculty of Medicine, Chulalongkorn University,
        • Contact:
      • Bangkok, Thailand
        • Recruiting
        • Faculty of Medicine, Ramathibodi Hospital, Mahidol University
        • Contact:
      • Bangkok, Thailand
        • Recruiting
        • Faculty of Medicine, Vajira Hospital, Navamindradhiraj University
        • Contact:
      • Bangkok, Thailand
        • Not yet recruiting
        • Phramongkutklao College of Medicine
        • Contact:
      • Bangkok, Thailand
        • Not yet recruiting
        • Police General Hospital
        • Contact:
      • Chanthaburi, Thailand
        • Not yet recruiting
        • Prapokklao Hospital (Chanthaburi),
        • Contact:
      • Chiang Mai, Thailand
        • Recruiting
        • Faculty of Medicine, Chiang Mai University,
        • Contact:
      • Chiang Mai, Thailand
        • Not yet recruiting
        • Nakornping Hospital
        • Contact:
      • Chiang rai, Thailand
        • Not yet recruiting
        • Chiangrai Prachanukroh Hospital
        • Contact:
      • Chon buri, Thailand
        • Recruiting
        • Chonburi hospital
        • Contact:
      • Chon buri, Thailand
        • Recruiting
        • Queen Savang Vadhana Memorial Hospital
        • Contact:
      • Khon Kaen, Thailand
        • Recruiting
        • Faculty of Medicine, Khon Kaen University
        • Contact:
      • Lampang, Thailand
        • Not yet recruiting
        • Lampang Hospital
        • Contact:
      • Nakhon Nayok, Thailand
        • Not yet recruiting
        • Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University
        • Contact:
      • Nakhon Pathom, Thailand
        • Not yet recruiting
        • Golden Jubilee Medical Center
        • Contact:
      • Nakhon Ratchasima, Thailand
        • Recruiting
        • Maharat Nakorn Ratchasima Hospital
        • Contact:
      • Nakhon Sawan, Thailand
        • Recruiting
        • Sawanpracharak Hospital
        • Contact:
      • Nonthaburi, Thailand
        • Recruiting
        • Central Chest Institute of Thailand
        • Contact:
      • Pathumthani, Thailand
        • Recruiting
        • Faculty of Medicine, Thammasat University, Rangsit Campus
        • Contact:
      • Phitsanulok, Thailand
        • Not yet recruiting
        • Buddhachinaraj Hospital
        • Contact:
      • Phitsanulok, Thailand
        • Not yet recruiting
        • Faculty of Medicine, Naresuan University
        • Contact:
      • Phuket, Thailand
        • Recruiting
        • Vachira Phuket Hospital
        • Contact:
      • Ratchaburi, Thailand
        • Recruiting
        • Ratchaburi Hospital
        • Contact:
      • Sakon nakhon, Thailand
        • Not yet recruiting
        • Sakonnakhon Hospital
        • Contact:
      • Songkla, Thailand
        • Recruiting
        • Faculty of Medicine, Prince of Songkla University
        • Contact:
      • Surat thani, Thailand
        • Recruiting
        • Suratthani Hospital
        • Contact:
      • Surin, Thailand
        • Recruiting
        • Surin hospital
        • Contact:
      • Ubon Ratchathani, Thailand
        • Recruiting
        • Sunpasitthiprasong Hospital
        • Contact:
      • Udon thani, Thailand
        • Recruiting
        • Udonthani Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed with atrial fibrillation

Description

Inclusion Criteria:

  • Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring.

Exclusion Criteria:

  1. Patients who have experienced an ischemic stroke within the past 3 months before enrollment.
  2. Patients with a platelet count less than 100,000/mm3 or who have myeloproliferative disorders (essential thrombocythemia, chronic myeloid leukemia, polycythemia vera, agnogenic myeloid metaplasia), hyperviscosity syndrome, chronic disseminated intravascular coagulation (DIC), or antiphospholipid syndrome.
  3. Patients with a mechanical prosthetic heart valve.
  4. Patients with rheumatic mitral stenosis.
  5. Patients participating in research projects with concealed treatments.
  6. Patients expected to have a life expectancy of less than 3 years due to other diseases, such as cancer or AIDS, as determined from medical records.
  7. Pregnancy.
  8. Patients unable to follow the treatment plan.
  9. Patients who do not consent to participate in the study.
  10. Patients who are hospitalized or discharged from the hospital within the past 1 month.Contact/Locations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with atrial fibrillation
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of warfarin and NOACs use
Time Frame: 3 years
3 years
Rate of ischemic stroke/TIA
Time Frame: 3 years
3 years
Rate of systemic embolism
Time Frame: 3 years
3 years
Rate of intracranial hemorrhage
Time Frame: 3 years
3 years
Rate of major bleeding
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Health Systems Research Institute
The Heart Association of Thailand

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA-CREC103-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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