Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2019-03-11

    Primary completion: 2024-06-30

    Study completion finish: 2025-12-30

    study type

    Study type

    PREVENTION

    phase

    Phase

      NA

    trial

    Trial ID

    NCT03785080

    Intervention or treatment

    OTHER: restart NOAC very early

    OTHER: restart NOAC early

    Conditions

    • Upper Gastrointestinal Bleeding
    Image related to Upper Gastrointestinal Bleeding
    • Condition: Upper Gastrointestinal Bleeding

    • OTHER: restart NOAC very early and other drugs

    • Blacktown, New South Wales, Australia

    • Sponsor: Chinese University of Hong Kong

    Find a site

    Closest Location:

    Blacktown Hospital

    Research sites nearby

    Select from list below to view details:

    • Blacktown Hospital

      Blacktown, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: restart NOAC very early
    • restart NOAC within 24 hours
    OTHER: restart NOAC very early
    • withhold NOAC less than 24 hours Post OGD
    ACTIVE_COMPARATOR: restart NOAC early
    • restart NOAC at 72 - 84 hours
    OTHER: restart NOAC early
    • withhold NOAC for 72 to 84 hours Post OGD

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    recurrent gastrointestinal bleedingmelaena and/or haematemesis with drop in Hb \>2g/dL and confirmation of bleeding by endoscopy.30 days

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    recurrent gastrointestinal bleedingmelaena and/or haematemesis with drop in Hb \>2g/dL and confirmation of bleeding by endoscopy.90 days
    Ischemic stroke or transient ischaemic attackan acute episode of neurologic deficit of presumed vascular or cardioembolic origin; its presence will be confirmed by a member of the neurology service30 days
    Systemic thromboembolismany clinical and/or radiographic acute stroke and/or an acute peripheral arterial thromboembolic event including acute limb ischaemia, coronary embolism and arterial thromboembolism30 days
    DeathAll-cause mortality6 months

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    References

    Clinical Trials Gov: Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients

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