Anticoagulation After GI Bleeding Pilot Study and Registry (NCT05290857) | Clinical Trial Compass
RecruitingNot Applicable
Anticoagulation After GI Bleeding Pilot Study and Registry
Canada100 participantsStarted 2022-03-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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