What side effects are associated with this type of intervention?

Common treatments for gastrointestinal bleeding include direct oral anticoagulants (DOACs) such as dabigatran, rivaroxaban, apixaban, and edoxaban. Known side effects of these medications include an increased risk of bleeding, gastrointestinal upset, and, in rare cases, liver enzyme abnormalities. Other treatments like proton pump inhibitors (PPIs) used to manage GI bleeding can cause side effects such as headache, diarrhea, constipation, and, with long-term use, an increased risk of bone fractures and kidney disease. It is essential to balance the benefits and risks of these treatments in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several direct oral anticoagulants (DOACs) for the prevention of thrombosis, which are relevant to the management of gastrointestinal bleeding. These include dabigatran, rivaroxaban, apixaban, and edoxaban. These drugs work by inhibiting clotting factors such as thrombin or factor Xa, thereby reducing the risk of thromboembolic events. The PANTHER-GI Pilot Study is investigating the safety of resuming these DOACs after a major GI bleeding event, highlighting their importance in balancing the prevention of thrombosis with the risk of re-bleeding.

What other types of research exist?

Promising novel alternatives to the standardized strategy for resuming DOACs in gastrointestinal bleeding patients include: 1) PAR-1 antagonists like vorapaxar, which have shown potential in reducing thrombotic events without significantly increasing bleeding risk. 2) Dual antiplatelet therapy (DAPT) with agents such as ticagrelor and aspirin, which has demonstrated efficacy in reducing major adverse limb events and could be considered for patients with concurrent cardiovascular conditions. 3) Adjusted dosing regimens based on pharmacokinetic data, which can optimize anticoagulation while minimizing bleeding risks. These alternatives should be discussed with a healthcare provider to tailor the best approach for individual patient needs.

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Anticoagulant

Timing for Restarting DOACs After Gastrointestinal Bleeding (PANTHER-GI Trial)

Q: What is the mechanism of action of this treatment?

Direct oral anticoagulants (DOACs) such as dabigatran, rivaroxaban, apixaban, and edoxaban work by inhibiting specific clotting factors (thrombin or factor Xa) to prevent thrombosis. This is particularly important for patients with gastrointestinal (GI) bleeding because while these medications reduce the risk of clot formation, they also increase bleeding risk. Managing this balance is crucial, and the PANTHER-GI Pilot Study aims to assess the safety of resuming DOACs after major GI bleeding, highlighting the need to carefully monitor and adjust treatment to optimize patient outcomes.

N/A

Recruiting

Led By Deborah M Siegal, MD MSc

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

OAC therapy discontinued for current acute GI bleed and not yet resumed

Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC)

Must not have

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

Renal dysfunction (Creatine Clearance <30 mL/min as calculated by the Cockcroft-Gault formula)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a plan for safely restarting blood thinners in patients who have had serious digestive system bleeding and are at high risk of both re-bleeding and blood clots. The timing of restarting the medication will be based on each patient's risk of developing blood clots.

Who is the study for?

This trial is for adults over 18 who were hospitalized with major non-variceal GI bleeding while on blood thinners, have stopped the thinner due to the bleed and haven't restarted it yet. They must need long-term anticoagulation for conditions like atrial fibrillation or VTE and be at risk of re-bleeding. Excluded are those with very low platelets, severe kidney issues, GI cancer history, surgical management of their bleed, short life expectancy from other causes, mechanical heart valve or certain types of VTE.

What is being tested?

The PANTHER-GI Pilot Study is testing when to safely restart blood thinners (DOACs) after a major gastrointestinal bleed—either within 7 days or between 7 to 14 days after stopping the bleeding. It aims to find out if this can prevent further bleeding and clotting in patients at moderate to high risk.

What are the potential side effects?

Potential side effects may include risks associated with restarting DOACs such as increased chances of new bleeding events or possibly clot-related complications if resumed too late. The exact side effects will depend on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I stopped my blood thinner due to a recent stomach bleed and haven't restarted it.

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I am hospitalized due to severe GI bleeding while on blood thinners.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had surgery to stop GI bleeding.

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My kidney function is low (Creatinine Clearance <30 mL/min).

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I have or had gastrointestinal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recruitment rate

Total recruitment

Secondary study objectives

Quality of life of Panther GI Research participants

acute ischemic stroke, transient ischemic attack or systemic embolism

acute symptomatic VTE

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Moderate thrombotic riskExperimental Treatment1 Intervention

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

Group II: High thrombotic riskExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Direct oral anticoagulants (DOACs) such as dabigatran, rivaroxaban, apixaban, and edoxaban work by inhibiting specific clotting factors (thrombin or factor Xa) to prevent thrombosis. This is particularly important for patients with gastrointestinal (GI) bleeding because while these medications reduce the risk of clot formation, they also increase bleeding risk. Managing this balance is crucial, and the PANTHER-GI Pilot Study aims to assess the safety of resuming DOACs after major GI bleeding, highlighting the need to carefully monitor and adjust treatment to optimize patient outcomes.

Network meta-analysis of anticoagulation strategies for venous thromboembolism in patients with cancer.