Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorOttawa Hospital Research Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Newly diagnosed VTE 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.
Disqualifiers
Therapeutic anticoagulation therapy for more than 7 days
Currently prescribed PPI for regular daily use (patients receiving H2 receptor antagonists will not be excluded),
Previous upper GI bleeding,
Need for dual antiplatelet therapy,
Trial design
Design model
Parallel
Treatments tested in this trial
Omeprazole 20 mg Oral Tablet
DrugOmeprazole once daily for 90 days
Placebo
Other interventionPlacebo once daily for 90 days
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Daily dose of omeprazole 20 mgExperimental treatment 1 intervention
Group B: Daily dose of placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Study feasibility at participating centres
The mean number of participants recruited per site per month
Time frame
24 monthsSecondary outcomes
1
Eligibility Rate
Proportion of screened patients who are eligible
Time frame
24 months2
Consent Rate
Proportion of eligible patients who provide consent
Time frame
24 months3
Retention Rate
Proportion of participants who completed all study procedures
Time frame
27 months4
Adherence Rate
adherence to study drug measured by pill count or assessing the patient diary at the end of follow-up
Time frame
27 monthsOther outcomes
1
Risk Factors
The proportion of participants with the following risk factors for bleeding at baseline: decreased kidney function (defined as estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73 m2), active cancer, concurrent antiplatelet and/or NSAID therapy, chronic liver disease, chronic anemia.
Time frame
24 months2
Patients already prescribed proton pump inhibitor
The proportion of screened patients already receiving prescribed proton pump inhibitor therapy
Time frame
24 months3
Reasons for Declining Participation
Patients are not required to provide a reason for declining to participate. However, for those patients who are willing to share, reasons for declining participation will be reviewed
Time frame
24 months4
New PPI prescription
The proportion of participants with new prescription for proton pump inhibitor during the study
Time frame
27 monthsSponsors and contacts
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Source ClinicalTrials.gov