[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546356":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":164,"collaborators":32,"id":166,"slug":32,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":32,"eligibilityCriteria":171,"healthyVolunteers":167,"sex":172,"minAge":173,"maxAge":32,"enrollmentInfo":174,"targetDuration":32,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Daily dose of omeprazole 20 mg","EXPERIMENTAL","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.",[13],"Drug: Omeprazole 20 mg Oral Tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Daily dose of placebo","PLACEBO_COMPARATOR","Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Omeprazole 20 mg Oral Tablet","Omeprazole once daily for 90 days",[9],[27],"Omeprazole",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Placebo once daily for 90 days",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Deborah Siegal, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","(613) 737-8899","78804","dsiegal@toh.ca",[44,68,86,103,119,134,149],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The Ottawa Hospital","RECRUITING","Ottawa","Ontario","K1H 8L6","Canada","CA",{"type":53,"coordinates":54},"Point",[55,56],-75.69812,45.41117,{"lat":56,"lon":55},[59,64,67],{"name":60,"role":39,"phone":61,"phoneExt":62,"email":63},"Erin Thomas","613-737-8899","79714","erithomas@ohri.ca",{"name":65,"role":39,"phone":32,"phoneExt":32,"email":66},"Jennifer Brinkhurst","jbrinkhurst@ohri.ca",{"name":35,"role":36,"phone":32,"phoneExt":32,"email":32},{"facility":69,"status":70,"city":71,"state":48,"zip":72,"country":50,"countryCode":51,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Niagara Health System - St. Catharines Site","NOT_YET_RECRUITING","St. Catharines","L2S 0A9",{"type":53,"coordinates":74},[75,76],-79.24267,43.17126,{"lat":76,"lon":75},[79,84],{"name":80,"role":39,"phone":81,"phoneExt":82,"email":83},"Kailee Morrison","905-378-4647","44268","kailee.morrison@niagarahealth.on.ca",{"name":85,"role":36,"phone":32,"phoneExt":32,"email":32},"Blair Leonard, MD",{"facility":87,"status":46,"city":88,"state":48,"zip":89,"country":50,"countryCode":51,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University Health Network - Toronto General","Toronto","M5G 2c4",{"type":53,"coordinates":91},[92,93],-79.39864,43.70643,{"lat":93,"lon":92},[96,101],{"name":97,"role":39,"phone":98,"phoneExt":99,"email":100},"Maria Dzyuba","416-340-4800","4628","maria.dzyuba@uhn.ca",{"name":102,"role":36,"phone":32,"phoneExt":32,"email":32},"Peter Gross, MD",{"facility":104,"status":70,"city":105,"state":106,"zip":107,"country":50,"countryCode":51,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"CIUSSS de l'Est-de- l'Île-de-Montréal","Montreal","Quebec","H1T2M4",{"type":53,"coordinates":109},[110,111],-73.58781,45.50884,{"lat":111,"lon":110},[114,117],{"name":115,"role":39,"phone":32,"phoneExt":32,"email":116},"Danaë Tassy","danae.tassy.cemtl@ssss.gouv.qc.ca",{"name":118,"role":36,"phone":32,"phoneExt":32,"email":32},"Marie-Pier Arsenault",{"facility":120,"status":46,"city":105,"state":106,"zip":121,"country":50,"countryCode":51,"cosmosGeoPoint":122,"geoPoint":124,"contacts":125},"Centre hospitalier de l'Université de Montréal","H2X 0A9",{"type":53,"coordinates":123},[110,111],{"lat":111,"lon":110},[126,129,132],{"name":127,"role":39,"phone":32,"phoneExt":32,"email":128},"Amélie Martin","amelie.martin.chum@ssss.gouv.qc.ca",{"name":130,"role":39,"phone":32,"phoneExt":32,"email":131},"Ève Comeau","eve.comeau.chum@ssss.gouv.qc.ca",{"name":133,"role":36,"phone":32,"phoneExt":32,"email":32},"Emmanuelle Duceppe",{"facility":135,"status":46,"city":136,"state":106,"zip":137,"country":50,"countryCode":51,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"CHU de Québec-Université Laval; Hôpital Saint-François d'Assise","Québec","G1R2J6",{"type":53,"coordinates":139},[140,141],-71.21454,46.81228,{"lat":141,"lon":140},[144,147],{"name":145,"role":39,"phone":32,"phoneExt":32,"email":146},"Guylaine Nadeau","guylaine.nadeau@chudequebec.ca",{"name":148,"role":36,"phone":32,"phoneExt":32,"email":32},"Guillaume Roberge",{"facility":150,"status":46,"city":136,"state":106,"zip":151,"country":50,"countryCode":51,"cosmosGeoPoint":152,"geoPoint":154,"contacts":155},"Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval","G1V4G5",{"type":53,"coordinates":153},[140,141],{"lat":141,"lon":140},[156,159,162],{"name":157,"role":39,"phone":32,"phoneExt":32,"email":158},"Andrea Murru","andrea.murru@crchudequebec.ulaval.ca",{"name":160,"role":39,"phone":32,"phoneExt":32,"email":161},"Luce Bouffard","Luce.Bouffard@criucpq.ulaval.ca",{"name":163,"role":36,"phone":32,"phoneExt":32,"email":32},"Vicky Mai",{"type":165,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100546356",false,"NCT06393868","Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism","Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism: Pilot Randomized Study (RADIANT Study)","Inclusion Criteria:\n\n1. 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.\n2. 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.\n3. Planned for 3 months (90 days) or more of therapeutic anticoagulation with any anticoagulant.\n4. Patient or delegate is able and willing to comply with follow-up examinations contained within the consent form.\n\nExclusion Criteria:\n\n1. Therapeutic anticoagulation therapy for more than 7 days\n2. Currently prescribed PPI for regular daily use (patients receiving H2 receptor antagonists will not be excluded),\n3. Previous upper GI bleeding,\n4. Need for dual antiplatelet therapy,\n5. Contraindications to omeprazole (hypersensitivity to omeprazole, or other substituted benzimidazole PPIs, concomitant use with products that contain rilpivirine, significant drug interactions, up to the discretion of the site investigator),\n6. Life expectancy is less than 3 months.","ALL","65 Years",{"count":175,"type":176},360,"ESTIMATED","INTERVENTIONAL",[179],"PHASE3","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.",[182,183,184],"Venous Thromboembolism","Gastro Intestinal Bleeding","Blood Clot",[27,186,187],"VTE","GI Bleeding","2026-01-20",{"date":190,"type":191},"2026-01-22","ACTUAL",{"date":193,"type":191},"2024-11-06",{"date":195,"type":176},"2028-03",{"name":5,"class":6},7]