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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    552
  • sponsor
    Chinese University of Hong Kong
Updated on 3 February 2022

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.

Description

The effectiveness and relative safety of NOACs have been demonstrated in large international studies where reductions in the incidence of stroke in patients with AF have been reported. However, the benefits of an anticoagulant are offset by increased incident rates of bleeding including gastrointestinal bleeding (GIB) and, less commonly, intracranial bleeding, warranting careful anticoagulation management during periods when patients are susceptible to the risks for bleeding, stroke and thromboembolism.

The exact duration for withholding NOAC after acute GIB is unknown and in general, 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, 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.

The purpose of this study is to determine if restarting NOAC very early after endoscopic haemostasis of bleeding peptic ulcer lesions is equivalent to early resumption in AF patients in terms of safety and efficacy for prevention of recurrent bleeding freedom from GIB recurrence, while maintaining undiminished benefits in reducing incident rates of systemic thromboembolism.

Details
Condition Upper Gastrointestinal Bleeding
Treatment restart NOAC very early, restart NOAC early
Clinical Study IdentifierNCT03785080
SponsorChinese University of Hong Kong
Last Modified on3 February 2022

Eligibility

Yes No Not Sure

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
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