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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03785080
Ethics application status
Date submitted
20/12/2018
Date registered
24/12/2018
Date last updated
16/04/2019

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
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

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 - melaena and/or haematemesis with drop in Hb >2g/dL and confirmation of bleeding by endoscopy.
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
recurrent gastrointestinal bleeding - melaena and/or haematemesis with drop in Hb >2g/dL and confirmation of bleeding by endoscopy.
Timepoint [1] 0 0
90 days
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Death - All-cause mortality
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
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 website
https://clinicaltrials.gov/show/NCT03785080
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03785080