Actively Recruiting
Anticoagulation After GI Bleeding Pilot Study and Registry
Led by Ottawa Hospital Research Institute · Updated on 2025-07-30
100
Participants Needed
2
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anticoagulation After GI Bleeding Pilot Study and Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older
- Hospitalized with acute major non-variceal GI bleeding while receiving oral anticoagulant therapy
- Oral anticoagulant therapy discontinued for current acute GI bleed and not yet resumed
- Ongoing indication for long-term anticoagulation of atrial fibrillation with CHA2DS2VASc score 3 or higher or venous thromboembolism
- Planned to resume direct oral anticoagulants after bleeding
- At moderate to high risk of re-bleeding as assessed by clinical team
- Clinical hemostasis achieved as assessed by clinical team
- Able and willing to comply with follow-up examinations in the consent form
You will not qualify if you...
- Mechanical heart valve
- Venous thromboembolism related to a major transient risk factor with completed 3 months treatment
- Gastrointestinal bleeding managed surgically (e.g., gastrectomy, colectomy)
- Active or previously treated gastrointestinal cancer
- Life expectancy less than 3 months from other causes
- Platelet count below 50,000/µL
- Renal dysfunction with creatinine clearance below 30 mL/min
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Alberta Health Services - Peter Lougheed Center Endoscopy Unit
Calgary, Alberta, Canada, T1Y 6J4
Actively Recruiting
2
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H8L6
Actively Recruiting
Research Team
D
Deborah M Siegal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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