Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism
NCT ID: NCT06393868
Last Updated: 2026-01-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
360 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-11-06
Study Completion Date
2028-03-31
Brief Summary
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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.
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Detailed Description
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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
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
Conditions
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Venous Thromboembolism
Gastro Intestinal Bleeding
Blood Clot
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Daily dose of omeprazole 20 mg
Participants randomized to the experimental arm will take one omeprazole 20 mg tablet by mouth every day for the duration of their participation in the study.
Group Type
EXPERIMENTAL
Omeprazole 20 mg Oral Tablet
Intervention Type
DRUG
Omeprazole once daily for 90 days
Daily dose of placebo
Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
Placebo once daily for 90 days
Interventions
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Omeprazole 20 mg Oral Tablet
Omeprazole once daily for 90 days
Intervention Type
DRUG
Placebo
Placebo once daily for 90 days
Intervention Type
OTHER
Other Intervention Names
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Omeprazole
Eligibility Criteria
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Inclusion Criteria
1. Male or female 65 years or older at the time of enrolment. Enrolment is limited to older adults as age is an important non-modifiable risk factor for bleeding. This will ensure the study population includes participants who may be more likely to benefit from omeprazole (compared to those with no risk factors) because all participants 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) DVT of upper or lower limbs, PE, cerebral vein thrombosis, portal vein thrombosis, other splanchnic vein thrombosis.
3. Planned for 3 months (90 days) or more of therapeutic anticoagulation with any anticoagulant.
4. Patient or delegate is able and willing to comply with follow-up examinations contained within the consent form.
2. Newly diagnosed VTE which includes VTE at any site such as (but not limited to) DVT of upper or lower limbs, PE, cerebral vein thrombosis, portal vein thrombosis, other splanchnic vein thrombosis.
3. Planned for 3 months (90 days) or more of therapeutic anticoagulation with any anticoagulant.
4. Patient or delegate is able and willing to comply with follow-up examinations contained within the consent form.
Exclusion Criteria
1. Therapeutic anticoagulation therapy for more than 7 days
2. Currently prescribed PPI for regular daily use (patients receiving H2 receptor antagonists will not be excluded),
3. Previous upper GI bleeding,
4. Need for dual antiplatelet therapy,
5. Contraindications to omeprazole (hypersensitivity to omeprazole, or other substituted benzimidazole PPIs, concomitant use with products that contain rilpivirine, significant drug interactions, up to the discretion of the site investigator),
6. Life expectancy is less than 3 months.
2. Currently prescribed PPI for regular daily use (patients receiving H2 receptor antagonists will not be excluded),
3. Previous upper GI bleeding,
4. Need for dual antiplatelet therapy,
5. Contraindications to omeprazole (hypersensitivity to omeprazole, or other substituted benzimidazole PPIs, concomitant use with products that contain rilpivirine, significant drug interactions, up to the discretion of the site investigator),
6. Life expectancy is less than 3 months.
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Deborah Siegal, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Locations
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The Ottawa Hospital
Ottawa, Ontario, Canada
Site Status
RECRUITING
Niagara Health System - St. Catharines Site
St. Catharines, Ontario, Canada
Site Status
NOT_YET_RECRUITING
University Health Network - Toronto General
Toronto, Ontario, Canada
Site Status
RECRUITING
CIUSSS de l'Est-de- l'Île-de-Montréal
Montreal, Quebec, Canada
Site Status
NOT_YET_RECRUITING
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Site Status
RECRUITING
CHU de Québec-Université Laval; Hôpital Saint-François d'Assise
Québec, Quebec, Canada
Site Status
RECRUITING
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, Canada
Site Status
RECRUITING
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RADIANT-001
Identifier Type: -
Identifier Source: org_study_id
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