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

Jul, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

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

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

Jul 30, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-07-30.