Anticoagulation After GI Bleeding Pilot Study and Registry

NCT05290857 · tracked via the Priya Life Science Canada tracker

Sponsor

Ottawa Hospital Research Institute

Phase

Not applicable

Started

2022-03-31

Last updated

2025-07-30

Condition(s) studied

GastroIntestinal BleedingAnticoagulant-induced Bleeding

Investigational drug(s) / intervention(s)

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

Restart DOAC within 7 days of clinical hemostasis after GI bleeding: 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: 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Male or female subjects aged 18 years or older 2. Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC). 3. OAC therapy discontinued for current acute GI bleed and not yet resumed 4. Ongoing indication for long-term anticoagulation of atrial fibrillation (moderate to high risk of stroke/systemic embolism with CHA2DS2VASc score of 3 or higher) or VTE (as per clinical care team) 5. Planned to resume DOAC post-bleed 6. At moderate to high risk of re-bleeding as per clinical care team 7. Clinical hemostasis achieved as per clinical care team 8. Able and willing to comply with follow-up examinations contained within the consent form Exclusion Criteria: 1. Mechanical heart valve 2. VTE in the context of major transient risk factor and completed 3 months of treatment 3. GI bleeding managed surgically (e.g. gastrectomy, colectomy) 4. Active or previously treated gastrointestinal cancer 5. Life expectancy from other causes of less than 3 months 6. Platelet count \< 50,000/µL (or \< 50x109/L) 7. Renal dysfunction (Creatine Clearance \<30 mL/min as calculated by the Cockcroft-Gault formula)

Primary outcome measure(s)

Recruitment rate — 18 months
The pilot study will be considered a success and to have demonstrated feasibility if average recruitment of 2 patients per month at each site is achieved.
Total recruitment — 18 months
Feasibility criterion of achieving recruitment of 85% of the target sample size of 100 patients

Trial sites (2)

Facility	City	Region	Status
Alberta Health Services - Peter Lougheed Center Endoscopy Unit	Calgary	Alberta	Recruiting
Ottawa Hospital Research Institute	Ottawa	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05290857 on ClinicalTrials.gov ↗ ← All trials in Canada