Recruiting

Observational Study

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05290857

Conditions

GastroIntestinal Bleeding

Anticoagulant-induced Bleeding

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Restart DOAC within 7 days of clinical hemostasis after GI bleeding

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

Study Details

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

Study ID

NCT05290857

Start date

Mar 31, 2022

Status verified date

Oct, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

All of the following criteria must be met for the patient to be eligible:

1. Male or female subjects aged 18 years or older
2. Hospitalized with acute major GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (DOAC).
3. OAC therapy discontinued for current acute GI bleed
4. 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)

Exclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High thrombotic risk

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

experimental: Moderate thrombotic risk

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

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

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.

Primary outcome measure

  • Recruitment rate [ Time Frame: 18 months ]
  • Total recruitment [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Deborah M Siegal, MD

613-737-8899dsiegal@toh.ca

Locations

Alberta Health Services - Peter Lougheed Center Endoscopy Unit

Recruiting

Calgary, Alberta, Canada, T1Y 6J4

Contacts

Nauzer Forbes, MD

(403) 943-4219nauzer.forbes@ucalgary.ca

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Deborah Siegal, MD

6137378899dsiegal@toh.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Oct 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.