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

NAUNKNOWN

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.

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.

Eligibility criteria

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

Inclusion criteria

  1. Age ≥18 years
  2. History of AF
  3. Taking any kind of NOAC at the time of index acute GIB
  4. Acute upper GIB (non-variceal bleeding lesions accounting for the GIB) with or without endoscopic treatment confirmed endoscopic haemostasis verified by GI specialist
  5. Patient or next-of-kin able to provide informed consent

Exclusion criteria

  1. Concomitant stroke (including TIA) at the time of index GIB
  2. Requiring bridging IV heparin therapy
  3. Portal hypertension
  4. Known bleeding diathesis
  5. Other conditions precluding use of NOAC at the time of randomisation
  6. Pregnancy
  7. Tumour bleeding
  8. Antidote administration to reverse anticoagulation effect of NOACs

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

PREVENTION

phase

Phase

    NA

trial

Study ID

NCT03785080

Intervention or treatment

OTHER: restart NOAC very early

OTHER: restart NOAC early

Conditions

  • 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

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Blacktown Hospital

Select from list below to view details:

  • Blacktown Hospital

    Blacktown, New South Wales, Australia

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Who is running the clinical trial?

CUoHK

Chinese University of Hong Kong

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
    ACTIVE_COMPARATOR: restart NOAC early
    • restart NOAC at 72 - 84 hours
    Other: restart NOAC early

      What is the study measuring?

      Primary Outcome

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

      Secondary Outcome

      MeasureDescriptionTime 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
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.

      References

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

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