Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism

Last updated: January 20, 2026
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Recruiting

Phase

3

Condition

Gastric Ulcers

Deep Vein Thrombosis

Ulcers

Treatment

Omeprazole 20 mg Oral Tablet

Placebo

Clinical Study ID

NCT06393868
RADIANT-001
  • Ages > 65
  • All Genders

Study Summary

The investigators are studying whether treatment with a proton pump inhibitor called omeprazole reduces gastrointestinal bleeding in older adults taking blood thinners for a blood clot (venous thromboembolism). The purpose of this study, a pilot study or a feasibility study, is to test the study plan and determine whether enough participants will join a larger study and accept the study procedures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female 65 years or older at the time of enrolment. Enrolment is limited toolder adults as age is an important non-modifiable risk factor for bleeding. Thiswill ensure the study population includes participants who may be more likely tobenefit from omeprazole (compared to those with no risk factors) because allparticipants will have at least 1 risk factor for bleeding.

  2. Newly diagnosed VTE which includes VTE at any site such as (but not limited to) DVTof upper or lower limbs, PE, cerebral vein thrombosis, portal vein thrombosis, othersplanchnic vein thrombosis.

  3. Planned for 3 months (90 days) or more of therapeutic anticoagulation with anyanticoagulant.

  4. Patient or delegate is able and willing to comply with follow-up examinationscontained within the consent form.

Exclusion

Exclusion Criteria:

  1. Therapeutic anticoagulation therapy for more than 7 days

  2. Currently prescribed PPI for regular daily use (patients receiving H2 receptorantagonists will not be excluded),

  3. Previous upper GI bleeding,

  4. Need for dual antiplatelet therapy,

  5. Contraindications to omeprazole (hypersensitivity to omeprazole, or othersubstituted benzimidazole PPIs, concomitant use with products that containrilpivirine, significant drug interactions, up to the discretion of the siteinvestigator),

  6. Life expectancy is less than 3 months.

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Omeprazole 20 mg Oral Tablet
Phase: 3
Study Start date:
November 06, 2024
Estimated Completion Date:
March 31, 2028

Study Description

Venous thromboembolism (VTE) refers to blood clots that form in the veins of the body, including the arms or legs (deep vein thrombosis [DVT]), abdomen (portal vein thrombosis), or lungs (pulmonary embolism [PE]). These blood clots are treated with medication to reduce blood clotting called anticoagulants. The main complication of anticoagulants is bleeding, the majority of which comes from the stomach or intestines (gastrointestinal tract). Anticoagulants do not cause bleeding, but they may make bleeding worse. Uncommonly, serious gastrointestinal (GI) bleeding can happen leading to hospitalization and even death. The chance of bleeding is highest in the first few months after starting anticoagulants.

Proton pump inhibitors (PPIs) are medications that lower the acid content of the stomach. The medication in this study, a type of proton pump inhibitor called omeprazole, is approved in Canada for treating stomach ulcers, heartburn, and a stomach infection called Helicobacter pylori. The use of omeprazole in this study is considered investigational. This means that Health Canada has not approved the use of omeprazole as a treatment for preventing gastrointestinal bleeding in patients taking anticoagulants. Some studies suggest that they may reduce gastrointestinal bleeding for people taking anticoagulants.

The investigators are studying whether treatment with a proton pump inhibitor called omeprazole reduces gastrointestinal bleeding in older adults taking anticoagulants for venous thromboembolism.

The investigators plan to do a large, randomized trial which is the best way to test the effect of a treatment. To do this, some of the participants in this study will get omeprazole and others will get a placebo (a substance that looks like the study omeprazole but does not have any active or medicinal ingredients). The placebo in this study is not intended to have any effect on bleeding. A placebo is used to make the results of the study more reliable.

Primary Objective To assess the feasibility of a full-scale double-blind placebo-controlled randomized trial to determine whether omeprazole reduces the risk of upper GI bleeding in older adults receiving anticoagulation for acute VTE compared to placebo.

Secondary Objectives:

  1. To measure additional feasibility outcomes

  2. To measure informative outcomes

  3. To measure key clinical outcomes

Connect with a study center

  • The Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Niagara Health System - St. Catharines Site

    St. Catharines, Ontario L2S 0A9
    Canada

    Site Not Available

  • University Health Network - Toronto General

    Toronto, Ontario M5G 2c4
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Active - Recruiting

  • Niagara Health System - St. Catharines Site

    St. Catharines 6155721, Ontario 6093943 L2S 0A9
    Canada

    Site Not Available

  • University Health Network - Toronto General

    Toronto 6167865, Ontario 6093943 M5G 2c4
    Canada

    Active - Recruiting

  • CIUSSS de l'Est-de- l'Île-de-Montréal

    Montreal 6077243, Quebec 6115047 H1T2M4
    Canada

    Site Not Available

  • Centre hospitalier de l'Université de Montréal

    Montreal 6077243, Quebec 6115047 H2X 0A9
    Canada

    Active - Recruiting

  • CHU de Québec-Université Laval; Hôpital Saint-François d'Assise

    Québec 6325494, Quebec 6115047 G1R2J6
    Canada

    Active - Recruiting

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

    Québec 6325494, Quebec 6115047 G1V4G5
    Canada

    Active - Recruiting

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