NCT06396299Recruiting
COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
Source: ClinicalTrials.gov · Last updated 9 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 4000 (estimated)
- First submitted
- 19 Apr 2024
- Start date
- 2 Jun 2024
- Primary completion date
- 1 Jun 2029
- Lead sponsor
- Mahidol University
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT06396299
What you commit to
- Study type: Observational
- Planned participants: 4000
- From 2 Jun 2024 to the primary completion date, 1 Jun 2029
- 33 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have experienced an ischemic stroke within the past 3 months before enrollment.
Other illness
- Patients with a mechanical prosthetic heart valve.
- 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.
Lab values
- 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.
Other
- Patients with rheumatic mitral stenosis.
- Patients participating in research projects with concealed treatments.
- Pregnancy.
- Patients unable to follow the treatment plan.
- Patients who do not consent to participate in the study.
- Patients who are hospitalized or discharged from the hospital within the past 1 month.Contact/Locations
Who the study is looking for
- Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Meddcine Siriraj Hospital, Mahidol University Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Rajavithi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Not yet recruiting |
| Faculty of Medicine Vajira Hospital, Navamindradhiraj University Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Bhumibol Adulyadej Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Faculty of Medicine, Ramathibodi Hospital, Mahidol University Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Phramongkutklao College of Medicine Coordinator of this site? Confirm its status | Bangkok | Thailand | Not yet recruiting |
| Faculty of Medicine Chulalongkorn University Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Police General Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Not yet recruiting |
| Charoen Krung Pracha Rak Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Prapokklao Hospital (Chanthaburi), Coordinator of this site? Confirm its status | Chanthaburi | Thailand | Not yet recruiting |
| Faculty of Medicine, Chiang Mai University Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Recruiting |
| Nakornping Hospital Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Not yet recruiting |
| Chiangrai Prachanukroh Hospital Coordinator of this site? Confirm its status | Chiang Rai | Thailand | Not yet recruiting |
| Chonburi Hospital Coordinator of this site? Confirm its status | Chon Buri | Thailand | Recruiting |
| Queen Savang Vadhana Memorial Hospital Coordinator of this site? Confirm its status | Chon Buri | Thailand | Recruiting |
| Faculty of Medicine Khon Kaen University Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Recruiting |
| Lampang Hospital Coordinator of this site? Confirm its status | Lampang | Thailand | Not yet recruiting |
| Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University Coordinator of this site? Confirm its status | Nakhon Nayok | Thailand | Not yet recruiting |
| Golden Jubilee Medical Center Coordinator of this site? Confirm its status | Nakhon Pathom | Thailand | Not yet recruiting |
| Maharat Nakorn Ratchasima Hospital Coordinator of this site? Confirm its status | Nakhon Ratchasima | Thailand | Recruiting |
| Sawanpracharak Hospital Coordinator of this site? Confirm its status | Nakhon Sawan | Thailand | Recruiting |
| Central Chest Institute of Thailand Coordinator of this site? Confirm its status | Nonthaburi | Thailand | Recruiting |
| Faculty of Medicine, Thammasat University, Rangsit Campus Coordinator of this site? Confirm its status | Pathum Thani | Thailand | Recruiting |
| Buddhachinaraj Hospital Coordinator of this site? Confirm its status | Phitsanulok | Thailand | Not yet recruiting |
| Faculty of Medicine, Naresuan University Coordinator of this site? Confirm its status | Phitsanulok | Thailand | Not yet recruiting |
| Vachira Phuket Hospital Coordinator of this site? Confirm its status | Phuket | Thailand | Recruiting |
| Ratchaburi Hospital Coordinator of this site? Confirm its status | Ratchaburi | Thailand | Recruiting |
| Sakonnakhon Hospital Coordinator of this site? Confirm its status | Sakon Nakhon | Thailand | Not yet recruiting |
| Faculty of Medicine, Prince of Songkla University Coordinator of this site? Confirm its status | Songkhla | Thailand | Recruiting |
| Suratthani Hospital Coordinator of this site? Confirm its status | Surat Thani | Thailand | Recruiting |
| Surin Hospital Coordinator of this site? Confirm its status | Surin | Thailand | Recruiting |
| Sunpasitthiprasong Hospital Coordinator of this site? Confirm its status | Ubon Ratchathani | Thailand | Recruiting |
| Udonthani Hospital Coordinator of this site? Confirm its status | Udon Thani | Thailand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.