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

StatusRecruiting
PhasePhase 3
Started2024-11-06
View on ClinicalTrials.gov ↗

Amendment history

2026-07-20
Study Status, Contacts/Locations v3
Study sitesdetails revised at 3 of 7 sites
2026-01-20
Study Status, Sponsor/Collaborators, Oversight, Eligibility, Contacts/Locations v2
Study sites3→7
Lead sponsorDeborah Siegal→Ottawa Hospital Research Institute
Eligibility criteria+61 characters
[...] participants will have at least 1 risk factor for bleeding. Acute VTENewly diagnosed within the previous 7 daysVTE which includes VTE at any site such as (but not limited to) [...] ions 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), previousPrevious upper GI bleeding, needNeed for dual antiplatelet therapy, contraindicationsContraindications to omeprazole (hypersensitivity to omeprazole, or other sub [...] Is, concomitant use with [...]
2025-07-28
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-09→2027-12
Completion date2024-09→2028-03
Start dateestimated 2024-06→confirmed 2024-11-06
Study sites0→3
2024-04-26
Original filing
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.
Trial Details
NCT Number NCT06393868
Lead Sponsor Ottawa Hospital Research Institute
Conditions Venous Thromboembolism, Gastro Intestinal Bleeding, Blood Clot
Enrollment 360 participants
Start Date 2024-11-06
Primary Completion 2027-12 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-22