360 Participants Needed

Omeprazole for Blood Clot

Recruiting at 2 trial locations
DS
Overseen ByDeborah Siegal, MD
Age: 65+
Sex: Any
Trial Phase: Phase 3
Sponsor: Deborah Siegal
Must be taking: Anticoagulants
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

DS

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

Patient or delegate is able and willing to comply with follow-up examinations contained within the consent form.
I am 65 years old or older.
I was diagnosed with a blood clot in the past week.
See 1 more

Exclusion Criteria

Life expectancy is less than 3 months.
I am currently taking a proton pump inhibitor (PPI) every day.
I have had bleeding in my stomach or upper intestines before.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either omeprazole or placebo daily to assess the reduction in gastrointestinal bleeding risk

90 days
Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

27 months

What Are the Treatments Tested in This Trial?

Interventions

  • Omeprazole
Trial Overview The study tests if omeprazole, a proton pump inhibitor, can reduce gastrointestinal bleeding in older adults taking anticoagulants. It's a pilot study to see if enough people will join and follow through with a larger future study.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Daily dose of omeprazole 20 mgExperimental Treatment1 Intervention
Group II: Daily dose of placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Deborah Siegal

Lead Sponsor

Trials
1
Recruited
360+

Citations

A network meta-analysis: evaluating the efficacy and safety of ...This study is the first network meta-analysis to identify the most effective regimen for the concurrent use of clopidogrel with individual PPIs.
Reducing Gastrointestinal Bleeding With Proton Pump ...The investigators are studying whether treatment with a proton pump inhibitor called omeprazole reduces gastrointestinal bleeding in older adults taking ...
Effect of proton pump inhibitors on clinical outcome in ...Administration of PPIs together with clopidogrel corresponded to a 29% increased risk of combined major cardiovascular events.
Proton‐pump inhibitors for the prevention of upper ...In addition, observational data suggest that the cotreatment with PPIs reduces the risk of UGIB in people receiving warfarin (Ray 2016). However ...
Conflicting Results Between Randomized Trials and ...Effect on Stent Thrombosis at ≈1 Year​​ A nonsignificant difference in stent thrombosis was found among patients discharged on omeprazole compared with those ...
Safety assessment of omeprazole use: a review - PMCTherefore, the data confirm that there is no evidence of clinical outcomes (safety and effectiveness) resulting from unapproved use of omeprazole, such as ...
Association of Proton Pump Inhibitor Use on ...The use of a PPI was independently associated with a higher rate of cardiovascular events in patients with acute coronary syndrome receiving clopidogrel.
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