Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396299
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-19
Brief Title:
COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation COOL-AF Phase 2
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation COOL-AF Phase 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 strokesystemic embolism major bleeding myocardial infarction heart failure and quality of life
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 strokesystemic embolism major bleeding myocardial infarction heart failure and quality of life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None