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Taking peoplePhase 3

Omeprazole to Lower Stomach Bleeding in Older Adults on Blood Thinners for Blood Clots

Tests omeprazole against placebo for gut bleeding in older adults treated for blood clots.

Key facts

Who runs it
Ottawa Hospital Research Institute
Where
Canada7 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism
Status
Recruiting
Phase
Phase 3
People taking part
360 people, planned
Started
6 Nov 2024
Expected to end
Mar 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Omeprazole 20 mg Oral Tablet
  • Placebo
Record updated
22 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 65 or older with a newly found blood clot (venous thromboembolism) who will take blood thinners. It tests whether omeprazole lowers bleeding in the stomach and gut.

Age
65 years or older
Sex
All sexes
Disease stage
Newly diagnosed blood clot at any site, for example in the arm or leg veins (DVT), lungs (PE), brain veins or belly veins.
Earlier treatment
Blood thinner treatment must be planned for 3 months (90 days) or more. People who have had full-dose blood thinners for more than 7 days cannot join.

Main reasons for not taking part

  • Already taking a PPI (stomach acid drug) every day. H2 receptor antagonists are allowed.
  • Earlier bleeding in the upper stomach or gut
  • Need for two antiplatelet drugs (dual antiplatelet therapy)
  • Allergy to omeprazole or similar PPIs, use of rilpivirine, or serious drug interactions
  • Expected to live less than 3 months

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Daily dose of omeprazole 20 mgTreatment being tested

    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.

    Treatment: Omeprazole 20 mg Oral Tablet

  • Daily dose of placeboPlacebo, for comparison

    Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism: Pilot Randomized Study (RADIANT Study)
Plain-language title
Omeprazole to Lower Stomach Bleeding in Older Adults on Blood Thinners for Blood ClotsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
22 July 2026