Assessing anticoagulation safety after gastrointestinal bleeding

Post-Bleed Management of Antithrombotic Therapy After Gastrointestinal Bleeding: Pilot Study and Registry (PANTHER-GI)

This study is testing a new way to safely restart blood thinners for patients who have had serious stomach bleeding to see how soon it can be done without causing more problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Locations: 2 sites (Calgary, Alberta and 1 other locations)
• Trial ID: NCT05290857 on ClinicalTrials.gov

What this trial studies

The PANTHER-GI Pilot Study aims to evaluate the feasibility of a standardized approach for resuming direct oral anticoagulants (DOACs) in patients who have experienced major gastrointestinal bleeding. This pilot study will focus on patients at moderate to high risk of re-bleeding and thrombosis, determining the optimal timeframe for resuming DOAC therapy based on individual thrombotic risk. Additionally, a parallel registry will be established to compare enrolled patients with those who are eligible but not participating, identifying barriers to enrollment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have been hospitalized for acute major non-variceal gastrointestinal bleeding and require long-term anticoagulation.

Not a fit: Patients with mechanical heart valves, recent major transient risk factors for VTE, or those who have undergone surgical management of GI bleeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer protocol for resuming anticoagulation therapy, reducing the risk of re-bleeding and thrombotic events in patients.

How similar studies have performed: Other studies have explored anticoagulation management after GI bleeding, but this specific approach is novel in its standardized protocol for DOAC resumption.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects aged 18 years or older
2. Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC).
3. OAC therapy discontinued for current acute GI bleed and not yet resumed
4. 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)
5. Planned to resume DOAC post-bleed
6. At moderate to high risk of re-bleeding as per clinical care team
7. Clinical hemostasis achieved as per clinical care team
8. Able and willing to comply with follow-up examinations contained within the consent form

Exclusion Criteria:

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

Where this trial is running

Calgary, Alberta and 1 other locations

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

Study contacts

• Principal investigator: Deborah M Siegal, MD MSc — Ottawa Hospital Research Institute
• Study coordinator: Deborah M Siegal, MD

Conditions GastroIntestinal Bleeding; Anticoagulant-induced Bleeding