Lowering stomach and intestinal bleeding with omeprazole in older adults with a new blood clot

Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism: Pilot Randomized Study (RADIANT Study)

This pilot will test whether taking omeprazole reduces stomach or intestinal bleeding in people 65 and older who are starting blood thinners for a new venous blood clot.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Locations: 7 sites (Ottawa, Ontario and 6 other locations)
• Trial ID: NCT06393868 on ClinicalTrials.gov

What this trial studies

This pilot interventional study assigns participants to take daily omeprazole 20 mg or a matching placebo while they receive standard anticoagulant therapy for a newly diagnosed venous thromboembolism. Eligible participants are adults aged 65 and older who plan at least 90 days of therapeutic anticoagulation. Investigators will track gastrointestinal and other bleeding events and study adherence during the anticoagulation period. The main purpose is to test study procedures and enrollment feasibility to inform a larger definitive trial.

Who should consider this trial

Good fit: People aged 65 or older with a newly diagnosed VTE who plan to take anticoagulants for at least 90 days and can comply with follow-up are the ideal candidates.

Not a fit: Patients already on a regular proton pump inhibitor, those on therapeutic anticoagulation for more than seven days, or those unable to attend follow-up visits are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, omeprazole could reduce serious gastrointestinal bleeding and related hospitalizations in older adults taking anticoagulants.

How similar studies have performed: Observational studies and some trials suggest PPIs can lower gastrointestinal bleeding risk for people on blood thinners, but randomized evidence specifically in older VTE patients is limited.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. 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.
3. Planned for 3 months (90 days) or more of therapeutic anticoagulation with any anticoagulant.
4. Patient or delegate is able and willing to comply with follow-up examinations contained within the consent form.

Exclusion Criteria:

1. Therapeutic anticoagulation therapy for more than 7 days
2. Currently prescribed PPI for regular daily use (patients receiving H2 receptor antagonists will not be excluded),
3. Previous upper GI bleeding,
4. Need for dual antiplatelet therapy,
5. 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),
6. Life expectancy is less than 3 months.

Where this trial is running

Ottawa, Ontario and 6 other locations

• The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
• Niagara Health System - St. Catharines Site — St. Catharines, Ontario, Canada (Not_yet_recruiting)
• University Health Network - Toronto General — Toronto, Ontario, Canada (Recruiting)
• CIUSSS de l'Est-de- l'Île-de-Montréal — Montreal, Quebec, Canada (Not_yet_recruiting)
• Centre hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
• CHU de Québec-Université Laval; Hôpital Saint-François d'Assise — Québec, Quebec, Canada (Recruiting)
• Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Deborah Siegal, MD — Ottawa Hospital Research Institute
• Study coordinator: Deborah Siegal, MD

Conditions Venous Thromboembolism; Gastro Intestinal Bleeding; Blood Clot; Omeprazole; VTE; GI Bleeding