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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting
• University Health Network - Toronto General
  Toronto, Ontario, Canada Recruiting
• CIUSSS de l'Est-de- l'Île-de-Montréal
  Montreal, Quebec, Canada 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
• Email: dsiegal@toh.ca
• Phone: (613) 737-8899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.