Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT06393868
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06393868
Study Brief:
Protocol Section:
NCT06393868