Restarting blood thinners after gastrointestinal bleeding in atrial fibrillation patients
Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients (NOAC-GAP) - a Randomised Controlled Study
This study is testing whether starting blood thinners again right after treatment for gastrointestinal bleeding is safe and effective for people with atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 552 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 3 sites (Blacktown, New South Wales and 2 other locations) |
| Trial ID | NCT03785080 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the safety and efficacy of resuming non-warfarin oral anticoagulants (NOACs) very early after endoscopic treatment of upper gastrointestinal bleeding in patients with atrial fibrillation. It addresses a critical knowledge gap regarding the optimal timing for restarting anticoagulation therapy to prevent thromboembolic events while minimizing the risk of recurrent bleeding. Participants will be randomized to receive either very early or early resumption of NOACs following their gastrointestinal bleeding event. The study will evaluate outcomes related to recurrent bleeding and thromboembolic events.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a history of atrial fibrillation who experienced an acute upper gastrointestinal bleed and were on NOACs at the time.
Not a fit: Patients with conditions such as concomitant stroke, portal hypertension, or those requiring bridging IV heparin therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for safely resuming anticoagulation therapy, potentially reducing the risk of stroke and other complications in atrial fibrillation patients.
How similar studies have performed: While the specific timing for resuming NOACs after gastrointestinal bleeding has not been extensively studied, similar approaches in anticoagulation management have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Concomitant stroke (including TIA) at the time of index GIB * Requiring bridging IV heparin therapy * Portal hypertension * Known bleeding diathesis * Other conditions precluding use of NOAC at the time of randomisation * Pregnancy * Tumour bleeding * Antidote administration to reverse anticoagulation effect of NOACs
Where this trial is running
Blacktown, New South Wales and 2 other locations
- Blacktown Hospital — Blacktown, New South Wales, Australia (Recruiting)
- Endoscopy Center, Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
- National University Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Joseph SUNG, MD — Cuhk
- Study coordinator: Bing Yee SUEN, BSN
- Email: suenbingyee@cuhk.edu.hk
- Phone: +852 3505 2640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.