COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 33
- 主要终点
- Rate of ischemic stroke/TIA
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring.
排除标准
- •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.
- •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
结局指标
主要结局
Rate of ischemic stroke/TIA
时间窗: 3 years
Rate of warfarin and NOACs use
时间窗: 3 years
Rate of major bleeding
时间窗: 3 years
Rate of intracranial hemorrhage
时间窗: 3 years
Rate of systemic embolism
时间窗: 3 years
次要结局
未报告次要终点
研究者
Rungroj Krittayaphong
Professor
Mahidol University