Anticoagulation After GI Bleeding Pilot Study and Registry

NCT ID: NCT05290857

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

This pilot cohort management study will evaluate a protocolized strategy for resuming DOACs after major GI bleeding based on thrombotic risk among patients at moderate to high risk of rebleeding. The timeframe for resuming DOACs will be determined based on the patient's underlying thrombotic risk.

Conditions

GastroIntestinal Bleeding; Anticoagulant-induced Bleeding

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High thrombotic risk

For patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis after GI bleeding.

Group Type: EXPERIMENTAL

Restart DOAC within 7 days of clinical hemostasis after GI bleeding

Intervention Type: OTHER

In patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis (as judged by the clinical team).

High thrombotic risk includes the following:

(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 5 or higher (ii) Atrial fibrillation or atrial flutter with CHA2DS2VASc score or 3 to 4 with recent ischemic stroke, TIA or systemic embolism (within 6 months) (iii) VTE (proximal DVT or PE) within 3 months (iv) Recurrent VTE (proximal DVT or PE) (v) VTE (proximal DVT or PE) associated with antiphospholipid syndrome (if eligible for DOAC) (vi) VTE (proximal DVT or PE) associated with active non-GI cancer (vii) None of the above but considered high thrombotic risk as per investigator

Moderate thrombotic risk

For patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis after GI bleeding.

Group Type: EXPERIMENTAL

Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding

Intervention Type: OTHER

In patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis (as judged by the clinical team).

Moderate thrombotic risk includes the following:

(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 3 to 4 (ii) VTE (proximal DVT or PE) beyond 3 months

The type and dose of DOAC will be according to patient and physician choice and will be prescribed by the clinical care team.

Interventions

Restart DOAC within 7 days of clinical hemostasis after GI bleeding

In patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis (as judged by the clinical team).

High thrombotic risk includes the following:

(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 5 or higher (ii) Atrial fibrillation or atrial flutter with CHA2DS2VASc score or 3 to 4 with recent ischemic stroke, TIA or systemic embolism (within 6 months) (iii) VTE (proximal DVT or PE) within 3 months (iv) Recurrent VTE (proximal DVT or PE) (v) VTE (proximal DVT or PE) associated with antiphospholipid syndrome (if eligible for DOAC) (vi) VTE (proximal DVT or PE) associated with active non-GI cancer (vii) None of the above but considered high thrombotic risk as per investigator

Intervention Type: OTHER

Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding

In patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis (as judged by the clinical team).

Moderate thrombotic risk includes the following:

(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 3 to 4 (ii) VTE (proximal DVT or PE) beyond 3 months

The type and dose of DOAC will be according to patient and physician choice and will be prescribed by the clinical care team.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah M Siegal, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Alberta Health Services - Peter Lougheed Center Endoscopy Unit

Calgary, Alberta, Canada

Site Status: RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Deborah M Siegal, MD

Role: CONTACT

dsiegal@toh.ca

613-737-8899 ext. 78804

Facility Contacts

Nauzer Forbes, MD

Role: primary

nauzer.forbes@ucalgary.ca

(403) 943-4219

Deborah Siegal, MD

Role: primary

dsiegal@toh.ca

6137378899 ext. 78804

Other Identifiers

3349 20210798-01H

Identifier Type: -

Identifier Source: org_study_id