RecruitingNCT06396299

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


Sponsor

Mahidol University

Enrollment

4,000 participants

Start Date

Jun 2, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This observational study (COULTER) tracks real-world outcomes in patients who have both atrial fibrillation (an irregular heartbeat) and chronic kidney disease — examining which blood thinners are used and how well they prevent stroke and bleeding complications. **You may be eligible if...** - You have been diagnosed with atrial fibrillation - You also have chronic kidney disease (including those on dialysis or after kidney transplant) - You are being prescribed blood thinners (anticoagulants) for stroke prevention - You are at least 18 years old **You may NOT be eligible if...** - You have atrial fibrillation from a reversible cause (like recent surgery) - You are already enrolled in a conflicting interventional trial - You are unable to provide consent or complete follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention

No intervention


Locations(33)

Faculty of Meddcine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Faculty of Medicine, Chulalongkorn University,

Bangkok, Bangkok, Thailand

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Faculty of Medicine, Vajira Hospital, Navamindradhiraj University

Bangkok, Bangkok, Thailand

Phramongkutklao College of Medicine

Bangkok, Bangkok, Thailand

Police General Hospital

Bangkok, Bangkok, Thailand

Central Chest Institute of Thailand

Nonthaburi, Changwat Nonthaburi, Thailand

Faculty of Medicine, Prince of Songkla University

Songkhla, Changwat Songkhla, Thailand

Faculty of Medicine, Chiang Mai University,

Chiang Mai, Chiang Mai, Thailand

Bhumibol Adulyadej Hospital

Bangkok, Thailand

Charoen Krung Pracha Rak Hospital

Bangkok, Thailand

Rajavithi Hospital

Bangkok, Thailand

Prapokklao Hospital (Chanthaburi),

Chanthaburi, Thailand

Nakornping Hospital

Chiang Mai, Thailand

Chiangrai Prachanukroh Hospital

Chiang Rai, Thailand

Chonburi Hospital

Chon Buri, Thailand

Queen Savang Vadhana Memorial Hospital

Chon Buri, Thailand

Faculty of Medicine, Khon Kaen University

Khon Kaen, Thailand

Lampang Hospital

Lampang, Thailand

Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University

Nakhon Nayok, Thailand

Golden Jubilee Medical Center

Nakhon Pathom, Thailand

Maharat Nakorn Ratchasima Hospital

Nakhon Ratchasima, Thailand

Sawanpracharak Hospital

Nakhon Sawan, Thailand

Faculty of Medicine, Thammasat University, Rangsit Campus

Pathum Thani, Thailand

Buddhachinaraj Hospital

Phitsanulok, Thailand

Faculty of Medicine, Naresuan University

Phitsanulok, Thailand

Vachira Phuket Hospital

Phuket, Thailand

Ratchaburi Hospital

Ratchaburi, Thailand

Sakonnakhon Hospital

Sakon Nakhon, Thailand

Suratthani Hospital

Surat Thani, Thailand

Surin Hospital

Surin, Thailand

Sunpasitthiprasong Hospital

Ubon Ratchathani, Thailand

Udonthani Hospital

Udon Thani, Thailand

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