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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03785080




Registration number
NCT03785080
Ethics application status
Date submitted
20/12/2018
Date registered
24/12/2018
Date last updated
5/05/2020

Titles & IDs
Public title
Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients
Scientific title
Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients (NOAC-GAP) - a Randomised Controlled Study
Secondary ID [1] 0 0
NOAC-GAP
Universal Trial Number (UTN)
Trial acronym
NOAC-GAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Gastrointestinal Bleeding 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - restart NOAC very early
Other interventions - restart NOAC early

Experimental: restart NOAC very early - restart NOAC within 24 hours

Active comparator: restart NOAC early - restart NOAC at 72 - 84 hours


Other interventions: restart NOAC very early
withhold NOAC less than 24 hours Post OGD

Other interventions: restart NOAC early
withhold NOAC for 72 to 84 hours Post OGD
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
recurrent gastrointestinal bleeding
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
recurrent gastrointestinal bleeding
Timepoint [1] 0 0
90 days
Secondary outcome [2] 0 0
Ischemic stroke or transient ischaemic attack
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Systemic thromboembolism
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Death
Timepoint [4] 0 0
6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
552
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Chinese University of Hong Kong
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joseph SUNG, MD
Address 0 0
CUHK
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bing Yee SUEN, BSN
Address 0 0
Country 0 0
Phone 0 0
+852 3505 2640
Fax 0 0
Email 0 0
suenbingyee@cuhk.edu.hk
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03785080