Anticoagulation After GI Bleeding Pilot Study and Registry

Recruiting now · Not applicable

Conditions studied: GastroIntestinal Bleeding, Anticoagulant-induced Bleeding

In brief

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.

Key facts

Study ID: NCT05290857
Run by: Ottawa Hospital Research Institute
People needed: 100
Starts: 2022-03-31
Expected to finish: 2025-12-01
Last updated by the study team: 2025-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female subjects aged 18 years or older
Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC).
OAC therapy discontinued for current acute GI bleed and not yet resumed
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)
Planned to resume DOAC post-bleed
At moderate to high risk of re-bleeding as per clinical care team
Clinical hemostasis achieved as per clinical care team
Able and willing to comply with follow-up examinations contained within the consent form

You may not qualify if…

Mechanical heart valve
VTE in the context of major transient risk factor and completed 3 months of treatment
GI bleeding managed surgically (e.g. gastrectomy, colectomy)
Active or previously treated gastrointestinal cancer
Life expectancy from other causes of less than 3 months
Platelet count < 50,000/µL (or < 50x109/L)
Renal dysfunction (Creatine Clearance <30 mL/min as calculated by the Cockcroft-Gault formula)

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.