RecruitingPhase 3

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

Canada360 participantsStarted 2024-11-06

Plain-language 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.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Study feasibility at participating centres

Timeframe: 24 months

Trial details

NCT IDNCT06393868

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Deborah Siegal, MD

(613) 737-8899 dsiegal@toh.ca

View on ClinicalTrials.gov More Venous Thromboembolism trials