Assessing anticoagulation safety after gastrointestinal bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PANTHER-GI Pilot Study aims to evaluate the feasibility of a standardized approach for resuming direct oral anticoagulants (DOACs) in patients who have experienced major gastrointestinal bleeding. This pilot study will focus on patients at moderate to high risk of re-bleeding and thrombosis, determining the optimal timeframe for resuming DOAC therapy based on individual thrombotic risk. Additionally, a parallel registry will be established to compare enrolled patients with those who are eligible but not participating, identifying barriers to enrollment.

Why it matters

Who can join: the full rules

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

Where it's running

• Alberta Health Services - Peter Lougheed Center Endoscopy Unit
  Calgary, Alberta, Canada Recruiting
• Ottawa Hospital Research Institute
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Deborah M Siegal, MD MSc — Ottawa Hospital Research Institute
• Study coordinator: Deborah M Siegal, MD
• Email: dsiegal@toh.ca
• Phone: 613-737-8899

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Endovascular treatment outcomes after portal hypertension–related GI bleeding in cirrhosis

  This study tests how well endovascular procedures for portal hypertension–related GI bleeding work in adults with cirrhosis, and what factors predict outcomes.

  Recruiting University Medical Center Ho Chi Minh City (UMC) · Ho Chi Minh City · NCT07918378

• Tegoprazan to prevent GI complications in ischemic stroke patients on antiplatelet therapy

  This trial tests whether tegoprazan can lower gastrointestinal complications in adults with ischemic stroke or TIA who are starting antiplatelet therapy.

  Recruiting at 24 sites Phase 3 Hanyang University · Busan, Busan and 23 other locations · NCT07687706

• Routine use of Potassium Competitive Acid Blocker vs guideline GI protection in AMI with PCI

  This trial tests whether giving a potassium competitive acid blocker regularly after AMI with PCI and DAPT helps more than following standard GI protection guidelines.

  Recruiting Phase 3 Samsung Medical Center · Seoul · NCT07467213

• Managing gastrointestinal bleeding in people taking direct oral anticoagulants

  This project will see how doctors treat gastrointestinal bleeding in adults on direct oral anticoagulants and whether giving prothrombin complex concentrate (PCC) appears helpful and safe.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07333144

• Wireless optical capsule to detect upper gastrointestinal bleeding

  This trial will test a swallowed wireless optical capsule (HemoPill) to see if it can detect bleeding in adults with suspected upper gastrointestinal bleeding.

  Recruiting Chinese University of Hong Kong · Shatin, Hong Kong Island · NCT06715293

• Using physiological parameters to predict outcomes in cirrhotic patients with gastrointestinal bleeding

  This study is testing if certain health measurements can help doctors predict how well patients with liver cirrhosis and gastrointestinal bleeding will do, so they can provide better emergency care.

  Recruiting St. Martin De Porress Hospital · Tainan · NCT06680583

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.