Statins for Venous Event Reduction in Patients With Venous Thromboembolism
SAVER
1 other identifier
interventional
2,700
6 countries
31
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2021
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedStudy Start
First participant enrolled
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
January 15, 2026
January 1, 2026
6.9 years
March 20, 2020
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrent Major VTE
Symptomatic recurrent major VTE (proximal DVT or segmental or larger PE) occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin as compared with placebo.
Up to 60 months
Secondary Outcomes (4)
Post Thrombotic Syndrome
Up to 60 months
Number of participants diagnosed with non-major VTE during follow-up
Up to 60 months
Number of participants diagnosed with an arterial vascular event during follow-up
Up to 60 months
Number of deaths during study participation
Up to 60 months
Other Outcomes (1)
Number of participants who have a bleeding event during follow-up
Up to 60 months
Study Arms (2)
Rosuvastatin
EXPERIMENTALParticipants randomized to the experimental arm will take one rosuvastatin 20 mg tablet by mouth every day for the duration of their participation in the study.
Placebo
PLACEBO COMPARATORParticipants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.
Interventions
Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
Eligibility Criteria
You may qualify if:
- \. Symptomatic objectively confirmed proximal leg DVT (above the trifurcation of the popliteal vein) and/or PE (segmental or greater) diagnosed in the last 30 days.
You may not qualify if:
- 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;
- Stroke;
- Transient ischemic attack (TIA);
- Myocardial infarction (MI);
- Acute coronary syndromes;
- Stable/unstable angina;
- Coronary or other arterial revascularization;
- Known diagnosis of hypercholesterolemia or dyslipidemia;
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Institutes of Health Research (CIHR)collaborator
- Eastern Norway Health Authorities RHFcollaborator
- Southern health region, Norwaycollaborator
- British Heart Foundationcollaborator
- Ottawa Hospital Research Institutelead
- Programme hospitalier de recherche clinique, Francecollaborator
Study Sites (31)
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Queen Elizabeth II Hospital
Halifax, Nova Scotia, B3H 2Y9, Canada
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6, Canada
Juravinski Hospital
Hamilton, Ontario, L8V 1C3, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Hôpital Montfort
Ottawa, Ontario, K1K 0T2, Canada
Niagara Health - St. Catharines Site
St. Catharines, Ontario, L2S 0A9, Canada
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill Univeristy Health Centre
Montreal, Quebec, H4A 3J1, Canada
CIUSSS de-l'Ouest-de-l'Ile-de-Montreal -St. Mary's Hospital Center
Montreal, Quebec, H9R 2Y2, Canada
CHU de Quebec-Université Laval
Québec, Quebec, G1V 4G2, Canada
CHU d'Angers - Service d'accueil et traitement des Urgences
Angers, France
Brest University Hospital Centre
Brest, France
CHU de Clermont-Ferrand, Hôpital Gabriel Montpied
Clermont-Ferrand, France
APHP Hôpital Louis Mourier
Colombes, France
CHU de Dijon - Service d'imagerie diagnostique et thérapeutique
Dijon, France
GH La Rochelle - Ré-Aunis - Service de Médecine vasculaire
La Rochelle, France
Centre Hospitalier Universitaire De Saint Etienne
Saint-Etienne, France
CHI Toulon - La Seyne sur Mer - Hôpital Sainte Musse
Toulon, France
Mater Misericordiae University Hospital
Dublin, Ireland
University of Insubria
Varese, Italy
Ostfold Hopsital
Sarpsborg, Norway
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aurélien Delluc, MD
Ottawa Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2020
First Posted
March 24, 2020
Study Start
February 10, 2021
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share