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Anticoagulation After GI Bleeding Pilot Study and Registry

Sponsor: Ottawa Hospital Research Institute • ClinicalTrials.gov ID: NCT05290857

Registry updated: 2026-10-02

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Description

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.

Interventions

Restart DOAC within 7 days of clinical hemostasis after GI bleeding (Other)
In patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis (as judged by the clinical team). High thrombotic risk includes the following: (i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 5 or higher (ii) Atrial fibrillation or atrial flutter with CHA2DS2VASc score or 3 to 4 with recent ischemic stroke, TIA or systemic embolism (within 6 months) (iii) VTE (proximal DVT or PE) within 3 months (iv) Recurrent VTE (proximal DVT or PE) (v) VTE (proximal DVT or PE) associated with antiphospholipid syndrome (if eligible for DOAC) (vi) VTE (proximal DVT or PE) associated with active non-GI cancer (vii) None of the above but considered high thrombotic risk as per investigator
Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding (Other)
In patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis (as judged by the clinical team). Moderate thrombotic risk includes the following: (i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 3 to 4 (ii) VTE (proximal DVT or PE) beyond 3 months The type and dose of DOAC will be according to patient and physician choice and will be prescribed by the clinical care team.

Eligibility criteria

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

Conditions

GastroIntestinal Bleeding Anticoagulant-induced Bleeding

Locations

Alberta Health Services - Peter Lougheed Center Endoscopy Unit — Calgary, Alberta, Canada
Ottawa Hospital Research Institute — Ottawa, Ontario, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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