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

RecruitingPhase 3Ages 65 Years - anyAllOttawa Hospital Research Institute
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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. 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.
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What it tests

  • Omeprazole 20 mg Oral Tablet
  • Placebo
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Where

7 sites
The Ottawa Hospital
Ottawa, Canada
Niagara Health System - St. Catharines Site
St. Catharines, Canada
University Health Network - Toronto General
Toronto, Canada
CIUSSS de l'Est-de- l'Île-de-Montréal
Montreal, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Canada
CHU de Québec-Université Laval; Hôpital Saint-François d'Assise
Québec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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