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

Обзор

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.

Вмешательства

• Другое No intervention
  No intervention

Первичные конечные точки

• Rate of warfarin and NOACs use [Срок оценки: 3 years]
• Rate of ischemic stroke/TIA [Срок оценки: 3 years]
• Rate of systemic embolism [Срок оценки: 3 years]
• Rate of intracranial hemorrhage [Срок оценки: 3 years]
• Rate of major bleeding [Срок оценки: 3 years]

Критерии участия

Критерии включения

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

Критерии исключения

• Patients who have experienced an ischemic stroke within the past 3 months before enrollment.
• 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.
• Patients with a mechanical prosthetic heart valve.
• Patients with rheumatic mitral stenosis.
• Patients participating in research projects with concealed treatments.
• 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.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Таиланд · 33 центра

• Faculty of Meddcine Siriraj Hospital, Mahidol University — Bangkok
• Faculty of Medicine, Chulalongkorn University, — Bangkok
• Faculty of Medicine, Ramathibodi Hospital, Mahidol University — Bangkok
• Faculty of Medicine, Vajira Hospital, Navamindradhiraj University — Bangkok
• Phramongkutklao College of Medicine — Bangkok
• Police General Hospital — Bangkok
• Central Chest Institute of Thailand — Nonthaburi
• Faculty of Medicine, Prince of Songkla University — Songkhla
• … и ещё 25 центров

Публикации

• Krittayaphong R, Winijkul A, Rungpradubvong V, Apiyasawat S, Phrommintikul A, Chantrarat T, Methavigul K, Chichareon P, Makarawate P, Wongtheptien W, Kaolawanich Y, Lip GYH. The COOL-AF Phase 2 Registry: COhort of Antithrombotic Use and Clinical Outcomes in Atrial Fibrillation Patients. JACC Asia. 2025 Jan 21;5(1):191-202. doi: 10.1016/j.jacasi.2024.10.027. eCollection 2025 Jan. PMID 39896253

Идентификаторы

NCT: NCT06396299 · COA-CREC103-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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