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Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Study acronym: SAVER
StatusRecruiting
PhasePhase 3
Started2021-02-10
View on ClinicalTrials.gov ↗

Amendment history

2026-01-13
Study Status, Sponsor/Collaborators, Contacts/Locations v11
Lead sponsorAurelien Delluc→Ottawa Hospital Research Institute
2025-12-09
Study Status, Sponsor/Collaborators, Contacts/Locations v10
Study sites18→31
Lead sponsorOttawa Hospital Research Institute→Aurelien Delluc
Collaborators+191 characters
Canadian Institutes of Health Research (CIHR) Eastern Norway Health Authorities RHF Southern health region, Norway Programme hospitalier de recherche clinique, France British Heart Foundation
2025-06-23
Study Status, Eligibility, Contacts/Locations v9
Primary completion date2026-01→2028-01
Completion date2027-01→2028-04
Eligibility criteriarevised
[...] ia Unable or unwilling to provide written informed consent; ≤< 18 years of age; Women of childbearing potential unwilling [...]
Study sites18 entries, revised
AmsterdamCIUSSS Universityde-l'Ouest-de-l'Ile-de-Montreal -St. Mary's Hospital Center
2023-05-30
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 18 sites
2023-03-13
Study Status, Study Description, Contacts/Locations v7
Study sites15→18
Study description+1,416 characters
Recent research has demonstrated that it is plausible that statins have additive, and potentially even synergistic effects, in reducing recurrent VTE in patients managed with anticoagulant-based strategies. Furthermore, it is plausible that statins may reduce the risk of recurrent VTE in those not o [...]
Show 6 earlier versions
2022-09-20
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 15 sites
2022-01-18
Study Status, Eligibility, Contacts/Locations v5
Study sites12→15
Eligibility criteria+93 characters
[...] mental or greater) diagnosed in the last 30 days. Exclusion Criteria:criteria Unable or unwilling to provide written informed consent; ≤ 18 years of age; Women of childbearing potential unwilling to use appropriate contraception; Currently prescribed a statin; A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention: Diabetes,; Abdominal aortic aneurysm,; Peripheral arterial disease presumed to be of atherosclerotic origin,; Stroke,; Transient ischemic attack (TIA),; Myocardial infarction (MI),; Acute coronary syndromes,; Stab [...] [...]
2021-02-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-01→confirmed 2021-02-10
Study sitesdetails revised at 12 of 12 sites
2020-11-30
Study Status, Contacts/Locations v3
Primary completion date2025-10→2026-01
Completion date2026-04→2027-01
Start date2020-11→2021-01
2020-09-18
Study Status v2
Start date2020-04→2020-11
2020-03-25
Study Status, Study Design, Outcome Measures v1
Secondary endpoints4 entries, revised
NonNumber of participants diagnosed with non-major VTE during follow-up ArterialNumber Vascularof Eventparticipants diagnosed with an arterial vascular event during follow-up DeathNumber of deaths during study participation
2020-03-23
Original filing
The standard or usual treatment for patients diagnosed with deep vein thrombosis or pulmonary embolism is treatment with blood thinners (called anticoagulants). While treatment of blood clots with blood thinners is effective, some research has shown that adding a statin (medication used to lower cholesterol) may give extra protection. It is thought that statins can improve how cells along the walls of the vein control inflammation, which can prevent new blood clots from forming. The medication in this study, rosuvastatin, is approved in Canada for use as a cholesterol-lowering medication. The use of rosuvastatin in this study is considered investigational. This means that Health Canada has not approved the use of rosuvastatin as a treatment for blood clots. However, it has been approved for use in this research study. The purpose of this study is to examine if adding a statin (rosuvastatin) to the usual blood thinner treatment will decrease the risk of another blood clot forming. The investigators also hope to discover if taking a statin reduces damage to your veins. To do this, some of the participants in this study will get rosuvastatin and others will receive a placebo (a substance that looks like the study rosuvastatin but does not have any active or medicinal ingredients). The placebo in this study is not intended to have any effect on your blood clot. A placebo is used to make the results of the study more reliable.
Trial Details
NCT Number NCT04319627
Lead Sponsor Ottawa Hospital Research Institute
Collaborators: Canadian Institutes of Health Research (CIHR), Eastern Norway Health Authorities RHF, Southern health region, Norway, Programme hospitalier de recherche clinique, France, British Heart Foundation
Conditions Venous Thromboembolism, Blood Clot, Post Thrombotic Syndrome
Enrollment 2,700 participants
Start Date 2021-02-10
Primary Completion 2028-01 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-01-15