Anticoagulation After GI Bleeding Pilot Study and Registry
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Restart DOAC within 7 days of clinical hemostasis after GI bleeding
- Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov