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

NCT ID: NCT03785080

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 552 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2025-12-30

Brief 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.

Detailed 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.

Conditions

Upper Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

restart NOAC very early

restart NOAC within 24 hours

Group Type: EXPERIMENTAL

restart NOAC very early

Intervention Type: OTHER

withhold NOAC less than 24 hours Post OGD

restart NOAC early

restart NOAC at 72 - 84 hours

Group Type: ACTIVE_COMPARATOR

restart NOAC early

Intervention Type: OTHER

withhold NOAC for 72 to 84 hours Post OGD

Interventions

restart NOAC very early

withhold NOAC less than 24 hours Post OGD

Intervention Type: OTHER

restart NOAC early

withhold NOAC for 72 to 84 hours Post OGD

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Joseph JY SUNG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph SUNG, MD

Role: PRINCIPAL_INVESTIGATOR

CUHK

Locations

Blacktown Hospital

Blacktown, New South Wales, Australia

Site Status: RECRUITING

Endoscopy Center, Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

National University Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Australia; Hong Kong; Singapore

Central Contacts

Bing Yee SUEN, BSN

Role: CONTACT

suenbingyee@cuhk.edu.hk

+852 3505 2640

Ming Yeung HO, BSc

Role: CONTACT

andrewho@cuhk.edu.hk

+852 2637 1398

Facility Contacts

Raymond KWOK, MD

Role: primary

Joseph SUNG, MD

Role: primary

jjysung@cuhk.edu.hk

+852 3505 3132

Bing Yee SUEN, BSN

Role: backup

suenbingyee@cuhk.edu.hk

+852 3505 2640

Jimmy SO

Role: primary

Other Identifiers

NOAC-GAP

Identifier Type: -

Identifier Source: org_study_id