Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism
Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism: Pilot Randomized Study (RADIANT Study)
Ottawa Hospital Research Institute
360 participants
Nov 6, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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.
- 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.
- Planned for 3 months (90 days) or more of therapeutic anticoagulation with any anticoagulant.
- Patient or delegate is able and willing to comply with follow-up examinations contained within the consent form.
Exclusion Criteria6
- Therapeutic anticoagulation therapy for more than 7 days
- Currently prescribed PPI for regular daily use (patients receiving H2 receptor antagonists will not be excluded),
- Previous upper GI bleeding,
- Need for dual antiplatelet therapy,
- 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),
- Life expectancy is less than 3 months.
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Interventions
Omeprazole once daily for 90 days
Placebo once daily for 90 days
Locations(7)
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NCT06393868