NCT03785080

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
552

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

5.3 years

First QC Date

December 20, 2018

Last Update Submit

May 4, 2020

Conditions

Upper Gastrointestinal Bleeding

Keywords

gastrointestinal bleedingstrokethromboembolismatrial fibrillationNOAC

Outcome Measures

Primary Outcomes (1)

  • recurrent gastrointestinal bleeding

    melaena and/or haematemesis with drop in Hb \>2g/dL and confirmation of bleeding by endoscopy.

    30 days

Secondary Outcomes (4)

  • recurrent gastrointestinal bleeding

    90 days

  • Ischemic stroke or transient ischaemic attack

    30 days

  • Systemic thromboembolism

    30 days

  • Death

    6 months

Study Arms (2)

restart NOAC very early

EXPERIMENTAL

restart NOAC within 24 hours

Other: restart NOAC very early

restart NOAC early

ACTIVE COMPARATOR

restart NOAC at 72 - 84 hours

Other: restart NOAC early

Interventions

restart NOAC very earlyOTHER

withhold NOAC less than 24 hours Post OGD

restart NOAC very early
restart NOAC earlyOTHER

withhold NOAC for 72 to 84 hours Post OGD

restart NOAC early

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

MeSH Terms

Conditions

Gastrointestinal HemorrhageStrokeThromboembolismAtrial Fibrillation

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEmbolism and ThrombosisArrhythmias, CardiacHeart Diseases

Study Officials

  • Joseph SUNG, MD

    CUHK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Yee SUEN, BSN

CONTACT

+852 3505 2640suenbingyee@cuhk.edu.hk

Ming Yeung HO, BSc

CONTACT

+852 2637 1398andrewho@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 24, 2018

Study Start

March 11, 2019

Primary Completion

June 30, 2024

Study Completion

December 30, 2025

Last Updated

May 5, 2020

Record last verified: 2020-05

Locations

SG(1)HK(1)AU(1)