Actively Recruiting
Post-Bleed Management of Antithrombotic Therapy After Gastrointestinal Bleeding: Pilot Study and Registry (PANTHER-GI)
Led by Ottawa Hospital Research Institute · Updated on 2025-07-30
100
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety of restarting direct oral anticoagulants (DOACs) after a major gastrointestinal (GI) bleeding event in patients who have a moderate to high risk of bleeding again or developing blood clots. This pilot study aims to evaluate a standardized plan for resuming DOACs based on the patient's risk of clotting, helping to guide treatment decisions. A parallel registry will also compare patients who participate in the study with those who do not to understand any differences and explore challenges in enrolling patients. The study divides patients into two groups based on their thrombotic risk. Patients at high thrombotic risk will restart DOACs within 7 days after clinical hemostasis following GI bleeding. Those at moderate thrombotic risk will restart DOACs between 7 and 14 days after clinical hemostasis. The exact timing is determined by the clinical care team, and the type and dose of DOACs are chosen by the patient and their physician. No placebo or randomization is involved in this study. Participants will be monitored for 18 months to assess recruitment and adherence rates. During the study, researchers will evaluate outcomes such as repeat endoscopy, hospital readmissions, bleeding events, stroke, embolism, venous thromboembolism, mortality, functional status, and quality of life within 90 days after resuming DOACs. The study involves regular follow-up exams and data collection to assess these safety and clinical outcomes over time.
CONDITIONS
Brief 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 gastrointestinal 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 for atrial fibrillation with CHA2DS2VASc score of 3 or higher or venous thromboembolism
- Planned to resume direct oral anticoagulants after the bleed
- At moderate to high risk of re-bleeding as assessed by clinical team
- Clinical hemostasis achieved as determined by clinical team
- Able and willing to comply with follow-up examinations as per consent
You will not qualify if you...
- Presence of mechanical heart valve
- Venous thromboembolism related to major transient risk factor with completed 3 months of 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 less than 30 mL/min calculated by Cockcroft-Gault formula
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days after clinical hemostasis
Participants will resume direct oral anticoagulants (DOACs) after gastrointestinal bleeding based on their thrombotic risk. Those at high thrombotic risk will restart DOACs within 7 days of clinical hemostasis, while those at moderate thrombotic risk will restart DOACs between 7 and 14 days after clinical hemostasis.
1 to 2 visits depending on thrombotic risk and timing of DOAC resumption
Duration - 90 days
Participants are monitored for safety outcomes, including bleeding events, thrombotic events, and quality of life assessments for up to 90 days after restarting DOACs.
Approximately 3 visits over 90 days
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
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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