Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism
NCT06393868 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2026-01-22
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.
Conditions
- Venous Thromboembolism
- Gastro Intestinal Bleeding
- Blood Clot
Interventions
- DRUG
-
Omeprazole 20 mg Oral Tablet
Omeprazole once daily for 90 days
- OTHER
-
Placebo
Placebo once daily for 90 days
Sponsors & Collaborators
-
Ottawa Hospital Research Institute
lead OTHER
Principal Investigators
-
Deborah Siegal, MD · Ottawa Hospital Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-06
- Primary Completion
- 2027-12-31
- Completion
- 2028-03-31
Countries
- Canada
Study Locations
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