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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06396299
• Other study ID #: COA-CREC103-2023
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 1, 2030

Study information

• Verified date: April 2024
• Source: Mahidol University
• Contact: Pontawee Kaewcomdee, B.N.S
• Phone: 0815594286
• Email: pontawee.k[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: June 1, 2030
• Est. primary completion date: June 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who have experienced an ischemic stroke within the past 3 months before enrollment.

2. 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.

3. Patients with a mechanical prosthetic heart valve.

4. Patients with rheumatic mitral stenosis.

5. Patients participating in research projects with concealed treatments.

6. 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.

7. Pregnancy.

8. Patients unable to follow the treatment plan.

9. Patients who do not consent to participate in the study.

10. Patients who are hospitalized or discharged from the hospital within the past 1 month.Contact/Locations

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Thailand	Bhumibol Adulyadej Hospital	Bangkok
Thailand	Charoen Krung Pracha Rak Hospital	Bangkok
Thailand	Faculty of Meddcine Siriraj Hospital, Mahidol University	Bangkok
Thailand	Faculty of Medicine, Chulalongkorn University,	Bangkok
Thailand	Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Bangkok
Thailand	Faculty of Medicine, Vajira Hospital, Navamindradhiraj University	Bangkok
Thailand	Phramongkutklao College of Medicine	Bangkok
Thailand	Police General Hospital	Bangkok
Thailand	Rajavithi Hospital	Bangkok
Thailand	Prapokklao Hospital (Chanthaburi),	Chanthaburi
Thailand	Faculty of Medicine, Chiang Mai University,	Chiang Mai
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	Central Chest Institute of Thailand	Nonthaburi
Thailand	Faculty of Medicine, Thammasat University, Rangsit Campus	Pathumthani
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	Faculty of Medicine, Prince of Songkla University	Songkla
Thailand	Suratthani Hospital	Surat thani
Thailand	Surin Hospital	Surin
Thailand	Sunpasitthiprasong Hospital	Ubon Ratchathani
Thailand	Udonthani Hospital	Udon thani

Sponsors (3)

Lead Sponsor	Collaborator
Mahidol University	Health Systems Research Institute, The Heart Association of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of warfarin and NOACs use		3 years
Primary	Rate of ischemic stroke/TIA		3 years
Primary	Rate of systemic embolism		3 years
Primary	Rate of intracranial hemorrhage		3 years
Primary	Rate of major bleeding		3 years