Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism: Pilot Randomized Study (RADIANT Study)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The investigators are studying whether treatment with a proton pump inhibitor called omeprazole reduces gastrointestinal bleeding in older adults taking blood thinners for a blood clot (venous thromboembolism). The purpose of this study, a pilot study or a feasibility study, is to test the study plan and determine whether enough participants will join a larger study and accept the study procedures.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

• 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.

• Planned for 3 months (90 days) or more of therapeutic anticoagulation with any anticoagulant.

• Patient or delegate is able and willing to comply with follow-up examinations contained within the consent form.

Locations
Other Locations
Canada
The Ottawa Hospital
RECRUITING
Ottawa
Niagara Health System - St. Catharines Site
NOT_YET_RECRUITING
St. Catharines
University Health Network - Toronto General
NOT_YET_RECRUITING
Toronto
Contact Information
Primary
Deborah Siegal, MD
dsiegal@toh.ca
(613) 737-8899
Time Frame
Start Date: 2024-11-06
Estimated Completion Date: 2028-03
Participants
Target number of participants: 360
Treatments
Experimental: Daily dose of omeprazole 20 mg
Participants randomized to the experimental arm will take one omeprazole 20 mg tablet by mouth every day for the duration of their participation in the study.
Placebo_comparator: Daily dose of placebo
Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.
Sponsors
Leads: Deborah Siegal

This content was sourced from clinicaltrials.gov