NCT06396299 COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
| NCT ID | NCT06396299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2024-06-02 |
| Primary Completion | 2029-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,000 participants in total. It began in 2024-06-02 with a primary completion date of 2029-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Rungroj Krittayaphong, MD,FESC,FACC
PRINCIPAL INVESTIGATOR
Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol university
Frequently Asked Questions
Who can join the NCT06396299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06396299 currently recruiting?
Yes, NCT06396299 is actively recruiting participants. Contact the research team at pontawee.k@gmail.com for enrollment information.
Where is the NCT06396299 trial being conducted?
This trial is being conducted at Bangkok, Thailand, Bangkok, Thailand, Bangkok, Thailand, Bangkok, Thailand and 11 additional locations.
Who is sponsoring the NCT06396299 clinical trial?
NCT06396299 is sponsored by Mahidol University. The principal investigator is Rungroj Krittayaphong, MD,FESC,FACC at Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol university. The trial plans to enroll 4,000 participants.
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