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

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT06393868
Phase
PHASE3
Status
Recruiting
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Conditions

  • Blood Clot
  • Gastro Intestinal Bleeding
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omeprazole 20 mg Oral Tablet — DRUG
    Omeprazole once daily for 90 days
  • Placebo — OTHER
    Placebo once daily for 90 days

Study Details

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.

Key Dates

First listed
May 1, 2024
Start date
Nov 6, 2024
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Daily dose of omeprazole 20 mg
    Participants randomized to the experimental arm will take one omeprazole 20 mg tablet by mouth every day for the duration of their participation in the study.
  • Placebo Comparator: Daily dose of placebo
    Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.

Primary Outcome Measure

Study feasibility at participating centres [ Time Frame: 24 months ]

Central Contacts

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