Clinical trial NCT03785080: Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients
Official title: Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients (NOAC-GAP) - a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Keywords: gastrointestinal bleeding
stroke
thromboembolism
atrial fibrillation
NOAC
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: recurrent gastrointestinal bleeding
timeFrame: 30 days
Secondary outcomes:
measure: recurrent gastrointestinal bleeding
timeFrame: 90 days
measure: Ischemic stroke or transient ischaemic attack
timeFrame: 30 days
measure: Systemic thromboembolism
timeFrame: 30 days
measure: Death
timeFrame: 6 months
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Hong Kong
country: Hong Kong
facility: Endoscopy Center, Prince of Wales Hospital
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: CUHK
name: Joseph SUNG, MD
role: PRINCIPAL_INVESTIGATOR
References: