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Anticoagulation After GI Bleeding Pilot Study and Registry

RecruitingNAAges 18 Years - anyAllOttawa Hospital Research Institute
NCT05290857 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

PANTHER-GI Pilot Study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding among patients at moderate to high risk of re-bleeding and thrombosis. A parallel registry will assess whether eligible patients who are not enrolled in the PANTHER-GI Pilot Study are systematically different than enrolled patients and to explore barriers to enrolment.

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📋 Eligibility rules (as published)
Inclusion Criteria: All of the following criteria must be met for the patient to be eligible: 1. Male or female subjects aged 18 years or older 2. Hospitalized with acute major GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (DOAC). 3. OAC therapy discontinued for current acute GI bleed 4. Ongoing indication for long-term anticoagulation of atrial fibrillation (moderate to high risk of stroke/systemic embolism with CHADS65 ≥ 1 OR CHA2DS2VASc score of 3 or higher) or VTE (as per clinical care team) Exclusion Criteria: 1. Bleeding from esophageal varices 2. Low risk peptic ulcers (Forest IIc or III) 3. Mechanical heart valve 4. GI bleeding managed surgically (e.g. gastrectomy, colectomy) 5. Active gastrointestinal cancer (defined as per ISTH criteria) 6. Life expectancy from other causes of less than 3 months 7. Platelet count \< 50,000/µL (or \< 50x109/L) 8. Renal dysfunction (Creatine Clearance \<15 mL/min as calculated by the Cockcroft-Gault formula) 9. Unable or unwilling to provide informed consent and/or comply with follow-up requirements outlined within the consent form
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What it tests

  • Restart DOAC within 7 days of clinical hemostasis after GI bleeding
  • Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding
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Where

2 sites
Alberta Health Services - Peter Lougheed Center Endoscopy Unit
Calgary, Canada
Ottawa Hospital Research Institute
Ottawa, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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