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Recruiting NCT05290857

Anticoagulation After GI Bleeding Pilot Study and Registry

No phase Interventional GastroIntestinal Bleeding Anticoagulant-induced Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Restart DOAC within 7 days of clinical hemostasis after GI bleeding, Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding.
Who it may be relevant to
Registry conditions: GastroIntestinal Bleeding, Anticoagulant-induced Bleeding. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other 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
  • 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.

Primary outcome measures

  • Recruitment rate [Time frame: 18 months]
  • Total recruitment [Time frame: 18 months]
Secondary outcome measures (12)
  • eligibility [Time frame: 18 months]
  • consent [Time frame: 18 months]
  • completion of all required study procedures [Time frame: 18 months]
  • adherence [Time frame: 18 months]
  • repeat endoscopy [Time frame: 90 days]
  • re-hospitalization [Time frame: 90 days]
  • major bleeding [Time frame: 90 days]
  • clinically relevant non-major bleeding [Time frame: 90 days]
  • acute ischemic stroke, transient ischemic attack or systemic embolism [Time frame: 90 days]
  • acute symptomatic VTE [Time frame: 90 days]
  • net clinical benefit outcome rate [Time frame: 90 days]
  • all-cause mortality [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • Alberta Health Services - Peter Lougheed Center Endoscopy Unit — Calgary
  • Ottawa Hospital Research Institute — Ottawa

Identifiers

NCT: NCT05290857 · 3349 20210798-01H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗