Anticoagulation After GI Bleeding Pilot Study and Registry

NCT05290857 | Recruiting DMC

• 1 other identifier: 3349 20210798-01H
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

GastroIntestinal Bleeding; Anticoagulant-induced Bleeding

Outcome Measures

Primary Outcomes (2)

• Recruitment rate

  The pilot study will be considered a success and to have demonstrated feasibility if average recruitment of 2 patients per month at each site is achieved.

  18 months

• Total recruitment

  Feasibility criterion of achieving recruitment of 85% of the target sample size of 100 patients

  18 months

Secondary Outcomes (14)

• eligibility

  18 months

• consent

  18 months

• completion of all required study procedures

  18 months

• adherence

  18 months

• repeat endoscopy

  90 days

Study Arms (2)

High thrombotic risk

EXPERIMENTAL

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

Other: Restart DOAC within 7 days of clinical hemostasis after GI bleeding

Moderate thrombotic risk

EXPERIMENTAL

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

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

Interventions

Restart DOAC within 7 days of clinical hemostasis after GI bleeding 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

High thrombotic risk

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

Moderate thrombotic risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the following criteria must be met for the patient to be eligible:
• Male or female subjects aged 18 years or older
• Hospitalized with acute major GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (DOAC).
• OAC therapy discontinued for current acute GI bleed
• Ongoing indication for long-term anticoagulation of atrial fibrillation (moderate to high risk of stroke/systemic embolism with CHADS65 ≥ 1 OR CHA2DS2VASc score of 3 or higher) or VTE (as per clinical care team)

You may not qualify if:

• Bleeding from esophageal varices
• Low risk peptic ulcers (Forest IIc or III)
• Mechanical heart valve
• GI bleeding managed surgically (e.g. gastrectomy, colectomy)
• Active gastrointestinal cancer (defined as per ISTH criteria)
• Life expectancy from other causes of less than 3 months
• Platelet count \< 50,000/µL (or \< 50x109/L)
• Renal dysfunction (Creatine Clearance \<15 mL/min as calculated by the Cockcroft-Gault formula)
• Unable or unwilling to provide informed consent and/or comply with follow-up requirements outlined within the consent form

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

Alberta Health Services - Peter Lougheed Center Endoscopy Unit

Calgary, Alberta, T1Y 6J4, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6, Canada

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Deborah M Siegal, MD MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah M Siegal, MD

CONTACT

613-737-8899; dsiegal@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, multicenter, cohort management study and parallel registry

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: March 22, 2022
• Study Start: March 31, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)