Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients (NOAC-GAP) - a Randomised Controlled Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Current clinical society guidelines and statements are non-specific and relatively open-ended regarding the optimal timing to restart non-warfarin oral anticoagulant (NOAC) after gastrointestinal bleeding (GIB) in patients with atrial fibrillation (AF) who require the prophylactic medication for stroke prevention. These patients are at increased risk for devastating future thromboembolic events including stroke if NOAC is not resumed promptly, whilst premature resumption of anticoagulants can result in recurrent GIB, haemorrhage, anaemia, myocardial ischaemia and infarction in those with ischaemic heart disease, and even death. However, the question as to how early a NOAC can be safely restarted after acute GIB has not been previously answered, and there remains an important knowledge gap.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Age ≥18 years

• History of AF

• Taking any kind of NOAC at the time of index acute GIB

• Acute upper GIB (non-variceal bleeding lesions accounting for the GIB) with or without endoscopic treatment confirmed endoscopic haemostasis verified by GI specialist

• Patient or next-of-kin able to provide informed consent

Locations
Other Locations
Australia
Blacktown Hospital
RECRUITING
Blacktown
Hong Kong Special Administrative Region
Endoscopy Center, Prince of Wales Hospital
RECRUITING
Hong Kong
Singapore
National University Hospital
RECRUITING
Singapore
Contact Information
Primary
Bing Yee SUEN, BSN
suenbingyee@cuhk.edu.hk
+852 3505 2640
Backup
Ming Yeung HO, BSc
andrewho@cuhk.edu.hk
+852 2637 1398
Time Frame
Start Date: 2019-03-11
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 552
Treatments
Experimental: restart NOAC very early
restart NOAC within 24 hours
Active_comparator: restart NOAC early
restart NOAC at 72 - 84 hours
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov