Omeprazole for Blood Clot
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether omeprazole, a medication commonly used to reduce stomach acid, can prevent stomach bleeding in older adults taking blood thinners for a blood clot. The study aims to determine if enough participants will join and adhere to the study plan for a larger future trial. Participants will take either omeprazole or a placebo (a pill with no active medicine) daily. Eligible participants have been diagnosed with a blood clot in the past week and are beginning blood thinner treatment for at least three months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking a proton pump inhibitor (PPI) like omeprazole regularly. If you are on other medications, it's best to discuss with the trial team.
Is there any evidence suggesting that omeprazole is likely to be safe for humans?
Research has shown that omeprazole, a proton pump inhibitor (PPI), is generally safe and well-tolerated by many people. However, some studies suggest a higher risk of heart problems when PPIs are taken, especially with certain medications like clopidogrel. People with heart conditions should consider this information.
The FDA has already approved omeprazole for treating conditions like acid reflux, indicating a known safety record for these uses. This trial is part of a Phase 3 study, meaning earlier studies have already tested omeprazole for safety. This phase focuses on confirming its effectiveness and checking for any additional side effects.12345Why do researchers think this study treatment might be promising for blood clots?
Researchers are excited about using omeprazole for blood clots because it offers a novel approach compared to current treatments like anticoagulants, which primarily focus on thinning the blood to prevent clot formation. Omeprazole, commonly known for treating acid-related stomach issues, could potentially influence clot resolution by affecting certain pathways linked to clot stability and formation. This unique mechanism might offer an alternative for patients who cannot tolerate traditional blood thinners, potentially widening the options available for managing blood clots safely and effectively.
What evidence suggests that omeprazole might be an effective treatment for reducing gastrointestinal bleeding in older adults on blood thinners?
Research has shown that omeprazole, a medication that reduces stomach acid, can lower the risk of stomach bleeding in people taking blood thinners like warfarin. Observational data suggest that using omeprazole with these medications reduces this bleeding risk. Although some studies have noted possible heart-related risks with similar drugs, this trial examines omeprazole's ability to protect the stomach lining. Participants will receive either a daily dose of omeprazole or a placebo. In short, evidence indicates that omeprazole effectively prevents stomach bleeding for those on blood thinners.24567
Who Is on the Research Team?
Deborah Siegal, MD
Principal Investigator
Ottawa Hospital Research Institute
Are You a Good Fit for This Trial?
This trial is for adults aged 65 or older who have been diagnosed with a blood clot (venous thromboembolism) within the past week and will be on blood thinners for at least 3 months. Participants must be able to follow the study plan.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either omeprazole or placebo daily to assess the reduction in gastrointestinal bleeding risk
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Omeprazole
Find a Clinic Near You
Who Is Running the Clinical Trial?
Deborah Siegal
Lead Sponsor