Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism

Launched by DEBORAH SIEGAL · Apr 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether a medication called omeprazole can help reduce the risk of gastrointestinal bleeding in older adults who are taking blood thinners for a condition known as venous thromboembolism (VTE). VTE involves blood clots that can occur in various parts of the body, such as the legs or lungs. The study is designed for people aged 65 and older, as they are more likely to experience bleeding complications. To participate, individuals must have been diagnosed with VTE within the past week and plan to take blood thinners for at least three months.

Participants in this trial will be asked to follow specific procedures and attend follow-up appointments to monitor their health during the study. Importantly, this trial is still in the planning stages and has not yet started recruiting participants. It's also worth noting that some individuals may not be eligible, such as those who have had recent gastrointestinal bleeding or who are already taking similar medications for stomach issues. Overall, this study aims to gather information that could lead to better management of bleeding risks in older adults on blood thinners.

Gender

ALL

Eligibility criteria

• 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. Acute VTE diagnosed within the previous 7 days 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. Currently prescribed PPI for regular daily use (patients receiving H2 receptor antagonists will not be excluded),
• • 2. previous upper GI bleeding,
• • 3. need for dual antiplatelet therapy,
• • 4. contraindications to omeprazole (hypersensitivity to omeprazole, or other substituted benzimidazole PPIs, concomitant use with products that contain rilpivirine, up to the discretion of the site investigator),
• • 5. life expectancy is less than 3 months.