Venous ThromboembolismPhase 3NCT06393868
Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism
A Phase 3 study testing Omeprazole 20 mg Oral Tablet in people with Venous Thromboembolism and Gastro Intestinal Bleeding, run by Ottawa Hospital Research Institute at 7 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Venous Thromboembolism, Gastro Intestinal Bleeding, Blood Clot
- What is being tested?
- Omeprazole 20 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 7 sitesCanada
- Study dates
- 6 Nov 2024to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
- 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),
- Life expectancy is less than 3 months.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Recruiting
CIUSSS de l'Est-de- l'Île-de-Montréal
Montreal, Quebec, H1T2M4
Danaë Tassy, danae.tassy.cemtl@ssss.gouv.qc.ca
Marie-Pier Arsenault
- Recruiting
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
Amélie Martin, amelie.martin.chum@ssss.gouv.qc.ca
Ève Comeau, eve.comeau.chum@ssss.gouv.qc.ca
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Erin Thomas, erithomas@ohri.ca
Jennifer Brinkhurst, jbrinkhurst@ohri.ca
- Recruiting
CHU de Québec-Université Laval; Hôpital Saint-François d'Assise
Québec, Quebec, G1R2J6
Guylaine Nadeau, guylaine.nadeau@chudequebec.ca
Guillaume Roberge
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V4G5
Marie-Pier Hubert, marie-pier.hubert@criucpq.ulaval.ca
Luce Bouffard, Luce.Bouffard@criucpq.ulaval.ca
- Not yet recruiting
Niagara Health System - St. Catharines Site
St. Catharines, Ontario, L2S 0A9
Kailee Morrison, 905-378-4647 ext. 44268, kailee.morrison@niagarahealth.on.ca
Blair Leonard, MD
- Recruiting
University Health Network - Toronto General
Toronto, Ontario, M5G 2c4
Maria Dzyuba, 416-340-4800 ext. 4628, maria.dzyuba@uhn.ca
Peter Gross, MD
About this study
Official title: Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism: Pilot Randomized Study (RADIANT Study)
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.
Read the detailed description
Venous thromboembolism (VTE) refers to blood clots that form in the veins of the body, including the arms or legs (deep vein thrombosis [DVT]), abdomen (portal vein thrombosis), or lungs (pulmonary embolism [PE]). These blood clots are treated with medication to reduce blood clotting called anticoagulants. The main complication of anticoagulants is bleeding, the majority of which comes from the stomach or intestines (gastrointestinal tract). Anticoagulants do not cause bleeding, but they may make bleeding worse. Uncommonly, serious gastrointestinal (GI) bleeding can happen leading to hospitalization and even death. The chance of bleeding is highest in the first few months after starting anticoagulants.
Proton pump inhibitors (PPIs) are medications that lower the acid content of the stomach. The medication in this study, a type of proton pump inhibitor called omeprazole, is approved in Canada for treating stomach ulcers, heartburn, and a stomach infection called Helicobacter pylori. The use of omeprazole in this study is considered investigational. This means that Health Canada has not approved the use of omeprazole as a treatment for preventing gastrointestinal bleeding in patients taking anticoagulants. Some studies suggest that they may reduce gastrointestinal bleeding for people taking anticoagulants.
The investigators are studying whether treatment with a proton pump inhibitor called omeprazole reduces gastrointestinal bleeding in older adults taking anticoagulants for venous thromboembolism.
The investigators plan to do a large, randomized trial which is the best way to test the effect of a treatment. To do this, some of the participants in this study will get omeprazole and others will get a placebo (a substance that looks like the study omeprazole but does not have any active or medicinal ingredients). The placebo in this study is not intended to have any effect on bleeding. A placebo is used to make the results of the study more reliable.
Primary Objective To assess the feasibility of a full-scale double-blind placebo-controlled randomized trial to determine whether omeprazole reduces the risk of upper GI bleeding in older adults receiving anticoagulation for acute VTE compared to placebo.
Secondary Objectives:
- To measure additional feasibility outcomes
- To measure informative outcomes
- To measure key clinical outcomes
- Being tested
- Omeprazole 20 mg Oral Tablet, Placebo
- Keywords
- Omeprazole, VTE, GI Bleeding
- Medical subject headings
- Venous Thromboembolism, Gastrointestinal Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole 20 mg Oral TabletDrug
Also called Omeprazole
Omeprazole once daily for 90 days
PlaceboOther
Placebo once daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Omeprazole 20 mg Oral Tablet |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility at participating centres
The mean number of participants recruited per site per month
Measured: 24 months
Secondary outcomes (4)
Eligibility Rate
Proportion of screened patients who are eligible
Measured: 24 months
Consent Rate
Proportion of eligible patients who provide consent
Measured: 24 months
Retention Rate
Proportion of participants who completed all study procedures
Measured: 27 months
Adherence Rate
adherence to study drug measured by pill count or assessing the patient diary at the end of follow-up
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start6 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Siegal, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393868
- Sponsor's protocol ID
- RADIANT-001
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CONVERGE trials will be conducted within specific research domains under a core protocol outlining shared elements, including broad inclusion criteria, a minimum set of core outcomes, event adjudication, and data sharing to the CONVERGE shared data repository. Patients meeting domain-specific inclusion criteria can be enrolled in individual trials based on pre-defined additional characteristics. RADIANT will be the first trial conducted within the Acute VTE Treatment Domain.
Publications
Wendelboe AM, McCumber M, Hylek EM, Buller H, Weitz JI, Raskob G; ISTH Steering Committee for World Thrombosis Day. Global public awareness of venous thromboembolism. J Thromb Haemost. 2015 Aug;13(8):1365-71. doi: 10.1111/jth.13031. Epub 2015 Jul 14.
PubMed 26084415Delluc A, Tromeur C, Le Ven F, Gouillou M, Paleiron N, Bressollette L, Nonent M, Salaun PY, Lacut K, Leroyer C, Le Gal G, Couturaud F, Mottier D; EPIGETBO study group. Current incidence of venous thromboembolism and comparison with 1998: a community-based study in Western France. Thromb Haemost. 2016 Oct 28;116(5):967-974. doi: 10.1160/TH16-03-0205. Epub 2016 Jul 28.
PubMed 27465905Heit JA. Epidemiology of venous thromboembolism. Nat Rev Cardiol. 2015 Aug;12(8):464-74. doi: 10.1038/nrcardio.2015.83. Epub 2015 Jun 16.
PubMed 26076949Heit JA, Spencer FA, White RH. The epidemiology of venous thromboembolism. J Thromb Thrombolysis. 2016 Jan;41(1):3-14. doi: 10.1007/s11239-015-1311-6.
PubMed 26780736Ferrazzini E, Mean M, Stalder O, Limacher A, Rodondi N, Aujesky D. Incidence and clinical impact of bleeding events in older patients with acute venous thromboembolism. Blood Adv. 2023 Jan 24;7(2):205-213. doi: 10.1182/bloodadvances.2022007263.
PubMed 35381071Hlavacek P, Guo JD, Rosenblatt L, Keshishian A, Russ C, Mardekian J, Ferri M, Poretta T, Yuce H, McBane R. Safety, effectiveness, and health care cost comparisons among elderly patients with venous thromboembolism prescribed warfarin or apixaban in the United States Medicare population. Curr Med Res Opin. 2019 Dec;35(12):2043-2051. doi: 10.1080/03007995.2019.1653067. Epub 2019 Sep 3.
PubMed 31387467Linkins LA, Choi PT, Douketis JD. Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism: a meta-analysis. Ann Intern Med. 2003 Dec 2;139(11):893-900. doi: 10.7326/0003-4819-139-11-200312020-00007.
PubMed 14644891Aryal MR, Gosain R, Donato A, Yu H, Katel A, Bhandari Y, Dhital R, Kouides PA. Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world. Blood Adv. 2019 Aug 13;3(15):2381-2387. doi: 10.1182/bloodadvances.2019000572.
PubMed 31405948Sindet-Pedersen C, Staerk L, Pallisgaard JL, Gerds TA, Berger JS, Torp-Pedersen C, Gislason GH, Olesen JB. Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism: a nationwide study. Eur Heart J Cardiovasc Pharmacother. 2018 Oct 1;4(4):220-227. doi: 10.1093/ehjcvp/pvy021.
PubMed 29945162Catella J, Bertoletti L, Moustafa F, Nieto JA, Valle R, Pedrajas JM, Villalobos A, Quere I, Sarlon-Bartoli G, Monreal M; RIETE Investigators. Major gastrointestinal bleeding in patients receiving anticoagulant therapy for venous thromboembolism. Thromb Res. 2022 Jun;214:29-36. doi: 10.1016/j.thromres.2022.04.005. Epub 2022 Apr 13.
PubMed 35452869Dawwas GK, Leonard CE, Lewis JD, Cuker A. Risk for Recurrent Venous Thromboembolism and Bleeding With Apixaban Compared With Rivaroxaban: An Analysis of Real-World Data. Ann Intern Med. 2022 Jan;175(1):20-28. doi: 10.7326/M21-0717. Epub 2021 Dec 7.
PubMed 34871048Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.
PubMed 24344086Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.
PubMed 23425163Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.
PubMed 23991658Prins MH, Lensing AW, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Raskob GE, Berkowitz SD, Wells PS; EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013 Sep 20;11(1):21. doi: 10.1186/1477-9560-11-21.
PubMed 24053656
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism: Pilot Randomized Study (RADIANT Study)
- ClinicalTrials.gov ID
- NCT06393868
- Acronym / sponsor ID
- RADIANT-001
- Keywords
- Omeprazole, VTE, GI Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Venous thromboembolism (VTE) refers to blood clots that form in the veins of the body, including the arms or legs (deep vein thrombosis [DVT]), abdomen (portal vein thrombosis), or lungs (pulmonary embolism [PE]). These blood clots are treated with medication to reduce blood clotting called anticoagulants. The main complication of anticoagulants is bleeding, the majority of which comes from the stomach or intestines (gastrointestinal tract). Anticoagulants do not cause bleeding, but they may make bleeding worse. Uncommonly, serious gastrointestinal (GI) bleeding can happen leading to hospitalization and even death. The chance of bleeding is highest in the first few months after starting anticoagulants.
Proton pump inhibitors (PPIs) are medications that lower the acid content of the stomach. The medication in this study, a type of proton pump inhibitor called omeprazole, is approved in Canada for treating stomach ulcers, heartburn, and a stomach infection called Helicobacter pylori. The use of omeprazole in this study is considered investigational. This means that Health Canada has not approved the use of omeprazole as a treatment for preventing gastrointestinal bleeding in patients taking anticoagulants. Some studies suggest that they may reduce gastrointestinal bleeding for people taking anticoagulants.
The investigators are studying whether treatment with a proton pump inhibitor called omeprazole reduces gastrointestinal bleeding in older adults taking anticoagulants for venous thromboembolism.
The investigators plan to do a large, randomized trial which is the best way to test the effect of a treatment. To do this, some of the participants in this study will get omeprazole and others will get a placebo (a substance that looks like the study omeprazole but does not have any active or medicinal ingredients). The placebo in this study is not intended to have any effect on bleeding. A placebo is used to make the results of the study more reliable.
Primary Objective To assess the feasibility of a full-scale double-blind placebo-controlled randomized trial to determine whether omeprazole reduces the risk of upper GI bleeding in older adults receiving anticoagulation for acute VTE compared to placebo.
Secondary Objectives:
- To measure additional feasibility outcomes
- To measure informative outcomes
- To measure key clinical outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily dose of omeprazole 20 mg | Experimental | Drug: Omeprazole 20 mg Oral TabletParticipants 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. |
| Daily dose of placebo | Placebo comparator | Other: PlaceboParticipants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omeprazole 20 mg Oral TabletAlso: OmeprazoleOmeprazole once daily for 90 days | Drug | Daily dose of omeprazole 20 mg |
| PlaceboPlacebo once daily for 90 days | Other | Daily dose of placebo |
Primary outcome
Study feasibility at participating centres
Time frame: 24 months
The mean number of participants recruited per site per month
4 secondary outcomes
Eligibility Rate
Time frame: 24 months
Consent Rate
Time frame: 24 months
Retention Rate
Time frame: 27 months
Adherence Rate
Time frame: 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 26084415Wendelboe AM, McCumber M, Hylek EM, Buller H, Weitz JI, Raskob G; ISTH Steering Committee for World Thrombosis Day. Global public awareness of venous thromboembolism. J Thromb Haemost. 2015 Aug;13(8):1365-71. doi: 10.1111/jth.13031. Epub 2015 Jul 14.
- Background: PubMed 27465905Delluc A, Tromeur C, Le Ven F, Gouillou M, Paleiron N, Bressollette L, Nonent M, Salaun PY, Lacut K, Leroyer C, Le Gal G, Couturaud F, Mottier D; EPIGETBO study group. Current incidence of venous thromboembolism and comparison with 1998: a community-based study in Western France. Thromb Haemost. 2016 Oct 28;116(5):967-974. doi: 10.1160/TH16-03-0205. Epub 2016 Jul 28.
- Background: PubMed 26076949Heit JA. Epidemiology of venous thromboembolism. Nat Rev Cardiol. 2015 Aug;12(8):464-74. doi: 10.1038/nrcardio.2015.83. Epub 2015 Jun 16.
- Background: PubMed 26780736Heit JA, Spencer FA, White RH. The epidemiology of venous thromboembolism. J Thromb Thrombolysis. 2016 Jan;41(1):3-14. doi: 10.1007/s11239-015-1311-6.
- Background: PubMed 35381071Ferrazzini E, Mean M, Stalder O, Limacher A, Rodondi N, Aujesky D. Incidence and clinical impact of bleeding events in older patients with acute venous thromboembolism. Blood Adv. 2023 Jan 24;7(2):205-213. doi: 10.1182/bloodadvances.2022007263.
- Background: PubMed 31387467Hlavacek P, Guo JD, Rosenblatt L, Keshishian A, Russ C, Mardekian J, Ferri M, Poretta T, Yuce H, McBane R. Safety, effectiveness, and health care cost comparisons among elderly patients with venous thromboembolism prescribed warfarin or apixaban in the United States Medicare population. Curr Med Res Opin. 2019 Dec;35(12):2043-2051. doi: 10.1080/03007995.2019.1653067. Epub 2019 Sep 3.
- Background: PubMed 14644891Linkins LA, Choi PT, Douketis JD. Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism: a meta-analysis. Ann Intern Med. 2003 Dec 2;139(11):893-900. doi: 10.7326/0003-4819-139-11-200312020-00007.
- Background: PubMed 31405948Aryal MR, Gosain R, Donato A, Yu H, Katel A, Bhandari Y, Dhital R, Kouides PA. Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world. Blood Adv. 2019 Aug 13;3(15):2381-2387. doi: 10.1182/bloodadvances.2019000572.
- Background: PubMed 29945162Sindet-Pedersen C, Staerk L, Pallisgaard JL, Gerds TA, Berger JS, Torp-Pedersen C, Gislason GH, Olesen JB. Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism: a nationwide study. Eur Heart J Cardiovasc Pharmacother. 2018 Oct 1;4(4):220-227. doi: 10.1093/ehjcvp/pvy021.
- Background: PubMed 35452869Catella J, Bertoletti L, Moustafa F, Nieto JA, Valle R, Pedrajas JM, Villalobos A, Quere I, Sarlon-Bartoli G, Monreal M; RIETE Investigators. Major gastrointestinal bleeding in patients receiving anticoagulant therapy for venous thromboembolism. Thromb Res. 2022 Jun;214:29-36. doi: 10.1016/j.thromres.2022.04.005. Epub 2022 Apr 13.
- Background: PubMed 34871048Dawwas GK, Leonard CE, Lewis JD, Cuker A. Risk for Recurrent Venous Thromboembolism and Bleeding With Apixaban Compared With Rivaroxaban: An Analysis of Real-World Data. Ann Intern Med. 2022 Jan;175(1):20-28. doi: 10.7326/M21-0717. Epub 2021 Dec 7.
- Background: PubMed 24344086Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.
- Individual participant dataSharing planned: Yes. CONVERGE trials will be conducted within specific research domains under a core protocol outlining shared elements, including broad inclusion criteria, a minimum set of core outcomes, event adjudication, and data sharing to the CONVERGE shared data repository. Patients meeting domain-specific inclusion criteria can be enrolled in individual trials based on pre-defined additional characteristics. RADIANT will be the first trial conducted within the Acute VTE Treatment Domain.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah Siegal, MD principal investigator
Ottawa Hospital Research Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omeprazole 20 mg Oral Tablet in people with Venous Thromboembolism and Gastro Intestinal Bleeding, run by Ottawa Hospital Research Institute at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Siegal, MD ((613) 737-8899 ext. 78804, dsiegal@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility at participating centres (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06393868, which also lists 56 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.