Recruiting
Phase 3

Omeprazole

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT06393868

Conditions

Venous Thromboembolism

Gastro Intestinal Bleeding

Blood Clot

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Omeprazole 20 mg Oral Tablet

Placebo

Study Details

Brief summary:

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.

Conditions

Venous Thromboembolism

Gastro Intestinal Bleeding

Blood Clot

Study ID

NCT06393868

Start date

Nov 6, 2024

Status verified date

Jul, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Omeprazole 20 mg Oral Tablet

Omeprazole once daily for 90 days

Placebo

Placebo once daily for 90 days

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Jennifer Brinkhurst

jbrinkhurst@ohri.ca

Principal Investigator:

Deborah Siegal, MD

University Health Network - Toronto General

Recruiting

Toronto, Ontario, Canada, M5G 2c4

Contacts

Principal Investigator:

Peter Gross, MD

CIUSSS de l'Est-de- l'Île-de-Montréal

Recruiting

Montreal, Quebec, Canada, H1T2M4

Contacts

Principal Investigator:

Marie-Pier Arsenault

Centre hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Principal Investigator:

Emmanuelle Duceppe

CHU de Québec-Université Laval; Hôpital Saint-François d'Assise

Recruiting

Québec, Quebec, Canada, G1R2J6

Contacts

Principal Investigator:

Guillaume Roberge

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Recruiting

Québec, Quebec, Canada, G1V4G5

Contacts

Principal Investigator:

Vicky Mai

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Omeprazole
  • VTE
  • GI Bleeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-07-22.