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Anticoagulation After GI Bleeding Pilot Study and Registry

ConditionsGastroIntestinal BleedingAnticoagulant-induced Bleeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Bleeding from esophageal varices

Low risk peptic ulcers (Forest IIc or III)

Mechanical heart valve

GI bleeding managed surgically (e.g. gastrectomy, colectomy)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Restart DOAC within 7 days of clinical hemostasis after GI bleeding

    Other intervention

    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

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: High thrombotic riskExperimental treatment 1 intervention
Group B: Moderate thrombotic riskExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months
2

Total recruitment

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

Time frame
18 months

Secondary outcomes

1

eligibility

proportion of patients screened who are eligible to participate out of all patients screened

Time frame
18 months
2

consent

proportion of eligible patients who provide consent to participate out of all eligible patients

Time frame
18 months
3

completion of all required study procedures

proportion of patients who complete all required study procedures out of all enrolled patients

Time frame
18 months
4

adherence

proportion of patients who adhere to study treatment strategy (i.e. resumed DOAC within the specified timeframe) out of the total number of patients enrolled

Time frame
18 months

Other outcomes

Sponsors and contacts

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Ottawa Hospital Research Institute

Lead sponsor

Source ClinicalTrials.gov
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