Upper Gastrointestinal BleedingNOAC-GAPNCT03785080
Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients
A study testing restart NOAC very early and restart NOAC early in people with Upper Gastrointestinal Bleeding, run by Chinese University of Hong Kong at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- restart NOAC very early and restart NOAC early
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 11 Mar 2019to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Australia1 site, 1 recruiting
- Recruiting
Blacktown Hospital
Blacktown, New South Wales
Raymond KWOK, MD
Hong Kong1 site, 1 recruiting
- Recruiting
Endoscopy Center, Prince of Wales Hospital
Hong Kong
Joseph SUNG, MD, +852 3505 3132, jjysung@cuhk.edu.hk
Bing Yee SUEN, BSN, +852 3505 2640, suenbingyee@cuhk.edu.hk
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Jimmy SO
About this study
Official title: Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients (NOAC-GAP) - a Randomised Controlled Study
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.
Read the 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
- Being tested
- restart NOAC very early, restart NOAC early
- Keywords
- gastrointestinal bleeding, stroke, thromboembolism, atrial fibrillation, NOAC
- Medical subject headings
- Gastrointestinal Hemorrhage, Stroke, Thromboembolism, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restart NOAC very earlyOther
withhold NOAC less than 24 hours Post OGD
restart NOAC earlyOther
withhold NOAC for 72 to 84 hours Post OGD
| Study group | Role | What they receive |
|---|---|---|
| restart NOAC very early | Experimental | restart NOAC within 24 hours Receives: Other: restart NOAC very early |
| restart NOAC early | Active comparator | restart NOAC at 72 - 84 hours Receives: Other: restart NOAC early |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent gastrointestinal bleeding
melaena and/or haematemesis with drop in Hb >2g/dL and confirmation of bleeding by endoscopy.
Measured: 30 days
Secondary outcomes (4)
recurrent gastrointestinal bleeding
melaena and/or haematemesis with drop in Hb >2g/dL and confirmation of bleeding by endoscopy.
Measured: 90 days
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
Measured: 30 days
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
Measured: 30 days
Death
All-cause mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start11 Mar 2019
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph JY SUNG, Chinese University of Hong Kong
- Investigators
- Joseph SUNG, MD, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785080
- Sponsor's protocol ID
- NOAC-GAP
- Acronym
- NOAC-GAP
- Status last verified
- May 2020
- First submitted
- 20 Dec 2018
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients (NOAC-GAP) - a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03785080
- Acronym / sponsor ID
- NOAC-GAP / NOAC-GAP
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- gastrointestinal bleeding, stroke, thromboembolism, atrial fibrillation, NOAC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| restart NOAC very early | Experimental | Other: restart NOAC very earlyrestart NOAC within 24 hours |
| restart NOAC early | Active comparator | Other: restart NOAC earlyrestart NOAC at 72 - 84 hours |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| restart NOAC very earlywithhold NOAC less than 24 hours Post OGD | Other | restart NOAC very early |
| restart NOAC earlywithhold NOAC for 72 to 84 hours Post OGD | Other | restart NOAC early |
Primary outcome
recurrent gastrointestinal bleeding
Time frame: 30 days
melaena and/or haematemesis with drop in Hb >2g/dL and confirmation of bleeding by endoscopy.
4 secondary outcomes
recurrent gastrointestinal bleeding
Time frame: 90 days
Ischemic stroke or transient ischaemic attack
Time frame: 30 days
Systemic thromboembolism
Time frame: 30 days
Death
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph SUNG, MD principal investigator
CUHK
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restart NOAC very early and restart NOAC early in people with Upper Gastrointestinal Bleeding, run by Chinese University of Hong Kong at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Hong Kong, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bing Yee SUEN, BSN (+852 3505 2640, suenbingyee@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent gastrointestinal bleeding (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.