Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism
Venous Thromboembolism | Blood Clot | Gastro Intestinal BleedingThe 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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Participation Requirements
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Sex:
ALL -
Eligible Ages:
65 and up
Participation Criteria
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. Acute VTE diagnosed within the previous 7 days 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. Currently prescribed PPI for regular daily use (patients receiving H2 receptor antagonists will not be excluded),
2. previous upper GI bleeding,
3. need for dual antiplatelet therapy,
4. contraindications to omeprazole (hypersensitivity to omeprazole, or other substituted benzimidazole PPIs, concomitant use with products that contain rilpivirine, up to the discretion of the site investigator),
5. life expectancy is less than 3 months.
Study Location
The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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University Health Network - Toronto General
University Health Network - Toronto GeneralToronto, Ontario
Canada
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Niagara Health System - St. Catharines Site
Niagara Health System - St. Catharines SiteSt. Catharines, Ontario
Canada
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- Study Sponsored By
- Ottawa Hospital Research Institute
- Participants Required
- More Information
- Study ID:
NCT06393868