Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients

Upper Gastrointestinal Bleeding Clinical Trial

— NOAC-GAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03785080
• Other study ID #: NOAC-GAP
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2020
• Source: Chinese University of Hong Kong
• Contact: Bing Yee SUEN, BSN
• Phone: +852 3505 2640
• Email: suenbingyee[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 552
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Other:
• restart NOAC very early
withhold NOAC less than 24 hours Post OGD
• restart NOAC early
withhold NOAC for 72 to 84 hours Post OGD

Locations

Country	Name	City	State
Australia	Blacktown Hospital	Blacktown	New South Wales
Hong Kong	Endoscopy Center, Prince of Wales Hospital	Hong Kong
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Countries where clinical trial is conducted

Australia,  Hong Kong,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent gastrointestinal bleeding	melaena and/or haematemesis with drop in Hb >2g/dL and confirmation of bleeding by endoscopy.	30 days
Secondary	recurrent gastrointestinal bleeding	melaena and/or haematemesis with drop in Hb >2g/dL and confirmation of bleeding by endoscopy.	90 days
Secondary	Ischemic stroke or transient ischaemic attack	an acute episode of neurologic deficit of presumed vascular or cardioembolic origin; its presence will be confirmed by a member of the neurology service	30 days
Secondary	Systemic thromboembolism	any clinical and/or radiographic acute stroke and/or an acute peripheral arterial thromboembolic event including acute limb ischaemia, coronary embolism and arterial thromboembolism	30 days
Secondary	Death	All-cause mortality	6 months