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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
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

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Faculty of Meddcine Siriraj Hospital, Mahidol University
Coordinator of this site? Confirm its status
BangkokThailandRecruiting
Rajavithi Hospital
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BangkokThailandNot yet recruiting
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Coordinator of this site? Confirm its status
BangkokThailandRecruiting
Bhumibol Adulyadej Hospital
Coordinator of this site? Confirm its status
BangkokThailandRecruiting
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Coordinator of this site? Confirm its status
BangkokThailandRecruiting
Phramongkutklao College of Medicine
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BangkokThailandNot yet recruiting
Faculty of Medicine Chulalongkorn University
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BangkokThailandRecruiting
Police General Hospital
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BangkokThailandNot yet recruiting
Charoen Krung Pracha Rak Hospital
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BangkokThailandRecruiting
Prapokklao Hospital (Chanthaburi),
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ChanthaburiThailandNot yet recruiting
Faculty of Medicine, Chiang Mai University
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Chiang MaiThailandRecruiting
Nakornping Hospital
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Chiang MaiThailandNot yet recruiting
Chiangrai Prachanukroh Hospital
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Chiang RaiThailandNot yet recruiting
Chonburi Hospital
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Chon BuriThailandRecruiting
Queen Savang Vadhana Memorial Hospital
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Chon BuriThailandRecruiting
Faculty of Medicine Khon Kaen University
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Khon KaenThailandRecruiting
Lampang Hospital
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LampangThailandNot yet recruiting
Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University
Coordinator of this site? Confirm its status
Nakhon NayokThailandNot yet recruiting
Golden Jubilee Medical Center
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Nakhon PathomThailandNot yet recruiting
Maharat Nakorn Ratchasima Hospital
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Nakhon RatchasimaThailandRecruiting
Sawanpracharak Hospital
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Nakhon SawanThailandRecruiting
Central Chest Institute of Thailand
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NonthaburiThailandRecruiting
Faculty of Medicine, Thammasat University, Rangsit Campus
Coordinator of this site? Confirm its status
Pathum ThaniThailandRecruiting
Buddhachinaraj Hospital
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PhitsanulokThailandNot yet recruiting
Faculty of Medicine, Naresuan University
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PhitsanulokThailandNot yet recruiting
Vachira Phuket Hospital
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PhuketThailandRecruiting
Ratchaburi Hospital
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RatchaburiThailandRecruiting
Sakonnakhon Hospital
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Sakon NakhonThailandNot yet recruiting
Faculty of Medicine, Prince of Songkla University
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SongkhlaThailandRecruiting
Suratthani Hospital
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Surat ThaniThailandRecruiting
Surin Hospital
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SurinThailandRecruiting
Sunpasitthiprasong Hospital
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Ubon RatchathaniThailandRecruiting
Udonthani Hospital
Coordinator of this site? Confirm its status
Udon ThaniThailandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.