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Heartburn drug may shield seniors from bleeding while on blood thinners

NCT ID NCT06393868

Disease control Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This pilot study tests whether omeprazole, a common heartburn drug, can reduce gastrointestinal bleeding in adults 65 and older who take blood thinners for blood clots. Researchers will enroll 360 participants to see if a larger trial is feasible. The study focuses on recruitment and adherence, not yet on proving the drug works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Omeprazole (a proton pump inhibitor)
What this could lead to
If this pilot succeeds, it could lead to a larger study that may show omeprazole helps prevent stomach bleeding in older adults taking blood thinners for blood clots.
What could go wrong
This is a small pilot study to test feasibility, not effectiveness. It may not prove omeprazole works, and results may not apply to all patients. Omeprazole can have side effects like headache or diarrhea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Gastrointestinal Hemorrhage thrombotic disease venous thromboembolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood clot Gastro intestinal bleeding Venous thromboembolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Québec, Quebec, G1R2J6, Canada

  • CIUSSS de l'Est-de- l'Île-de-Montréal

    RECRUITING

    Montreal, Quebec, H1T2M4, Canada

  • Centre hospitalier de l'Université de Montréal

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

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

    RECRUITING

    Québec, Quebec, G1V4G5, Canada

  • Niagara Health System - St. Catharines Site

    NOT_YET_RECRUITING

    St. Catharines, Ontario, L2S 0A9, Canada

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • University Health Network - Toronto General

    RECRUITING

    Toronto, Ontario, M5G 2c4, Canada

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