Statins for Venous Event Reduction in Patients With Venous Thromboembolism (SAVER)

January 13, 2026 updated by: Ottawa Hospital Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 on anticoagulants and therefore offer an alternative in patients with contraindications to anticoagulants (e.g. after major intracranial bleed), who refuse to take anticoagulants long-term (e.g. due to lifestyle modifications or fear of bleeding) or who cannot afford anticoagulants (e.g. vulnerable or impoverished populations). Finally, statins may also provide protection from recurrent VTE in patients who are not fully compliant with anticoagulant therapy. However, no known RCTs have been done to explore these possibilities.

This study aims to determine if generic rosuvastatin reduces the risk of recurrent VTE compared to placebo in patients with symptomatic major VTE.

Primary Objectives

- To determine the primary outcome event rate (i.e. symptomatic recurrent major VTE [proximal DVT or segmental or larger PE]) in patients taking generic rosuvastatin compared to placebo.

Secondary Objectives

  • To determine the major bleeding event rate in patients taking generic rosuvastatin compared to placebo.
  • To explore if rosuvastatin reduces the incidence of PTS, as measured by the Villalta scale at end of study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Recruiting
        • Foothills Medical Centre
        • Principal Investigator:
          • Leslie Skeith, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Withdrawn
        • Queen Elizabeth II Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton General Hospital
        • Principal Investigator:
          • Sam Schulman, MD
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Joseph's Healthcare
        • Principal Investigator:
          • Jim Douketis, MD
      • Hamilton, Ontario, Canada, L8V 1C3
        • Withdrawn
        • Juravinski Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital
        • Principal Investigator:
          • Aurélien Delluc, MD
        • Contact:
      • Ottawa, Ontario, Canada, K1K 0T2
        • Withdrawn
        • Hôpital Montfort
      • St. Catharines, Ontario, Canada, L2S 0A9
        • Recruiting
        • Niagara Health - St. Catharines site
        • Principal Investigator:
          • Blair Leonard, MD
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network
        • Principal Investigator:
          • Erik Yeo, MD
      • Toronto, Ontario, Canada, M4N 3M5
        • Not yet recruiting
        • Sunnybrook Hospital
        • Principal Investigator:
          • Jean-Philippe Galanaud, MD
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Principal Investigator:
          • Susan Kahn, MD
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill Univeristy Health Centre
        • Principal Investigator:
          • Véronique Naessens, MD
      • Montreal, Quebec, Canada, H9R 2Y2
        • Recruiting
        • CIUSSS de-l'Ouest-de-l'Ile-de-Montreal -St. Mary's Hospital Center
        • Principal Investigator:
          • Carolyne Elbaz, MD
      • Québec, Quebec, Canada, G1V 4G2
        • Recruiting
        • CHU de Quebec-Universite Laval
        • Principal Investigator:
          • Guillaume Roberge, MD
  • France
      • Angers, France
        • Recruiting
        • CHU d'Angers - Service d'accueil et traitement des Urgences
        • Principal Investigator:
          • Jeane Hersant
      • Brest, France
        • Recruiting
        • Brest University Hospital Centre
        • Principal Investigator:
          • Raphael Le Mao, MD
      • Clermont-Ferrand, France
        • Recruiting
        • CHU de Clermont-Ferrand, Hôpital Gabriel Montpied
        • Principal Investigator:
          • Jeanot Schmidt, MD
      • Colombes, France
        • Recruiting
        • APHP Hôpital Louis Mourier
        • Principal Investigator:
          • Isabelle Mahe
      • Dijon, France
        • Recruiting
        • CHU de Dijon - Service d'imagerie diagnostique et thérapeutique
        • Principal Investigator:
          • Nicolas Falvo
      • La Rochelle, France
        • Recruiting
        • GH La Rochelle - Ré-Aunis - Service de Médecine vasculaire
        • Principal Investigator:
          • Christophe Roncato
      • Saint-Etienne, France
        • Recruiting
        • Centre Hospitalier Universitaire de Saint Etienne
        • Principal Investigator:
          • Laurant Bertoletti, MD
      • Toulon, France
        • Recruiting
        • CHI Toulon - La Seyne sur Mer - Hôpital Sainte Musse
        • Principal Investigator:
          • Jean-Noël Poggi
  • Ireland
      • Dublin, Ireland
        • Not yet recruiting
        • Mater Misericordiae University Hospital
        • Principal Investigator:
          • Fionnuala Ní Áinle, MD
  • Italy
      • Varese, Italy
        • Not yet recruiting
        • University of Insubria
        • Principal Investigator:
          • Walter Ageno, MD
  • Norway
      • Sarpsborg, Norway
        • Recruiting
        • Ostfold Hopsital
        • Principal Investigator:
          • Waleed Ghanima, MD
        • Contact:
          • Sven Arne Sogn
  • United Kingdom
      • Aberdeen, United Kingdom
        • Not yet recruiting
        • Aberdeen Royal Infirmary
        • Principal Investigator:
          • Mary-Joan Macleod
      • Birmingham, United Kingdom
        • Not yet recruiting
        • Queen Elizabeth Hospital
        • Principal Investigator:
          • Gillian Lowe
      • Cardiff, United Kingdom
        • Not yet recruiting
        • University Hospital of Wales
        • Principal Investigator:
          • Raza Alikhan
      • Glasgow, United Kingdom
        • Not yet recruiting
        • Glasgow Royal Infirmary
        • Principal Investigator:
          • Catherine Bagot
      • London, United Kingdom
        • Not yet recruiting
        • King's College Hospital NHS Foundation Trust
        • Principal Investigator:
          • Lara Roberts
      • Oxford, United Kingdom
        • Not yet recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Nicola Curry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. 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.

Exclusion criteria

  1. Unable or unwilling to provide written informed consent;
  2. < 18 years of age;
  3. Women of childbearing potential unwilling to use appropriate contraception;
  4. Currently prescribed a statin;

  5. A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention:

    1. Diabetes;
    2. Abdominal aortic aneurysm;
    3. Peripheral arterial disease;
    4. Stroke;
    5. Transient ischemic attack (TIA);
    6. Myocardial infarction (MI);
    7. Acute coronary syndromes;
    8. Stable/unstable angina;
    9. Coronary or other arterial revascularization;
  6. Known diagnosis of hypercholesterolemia or dyslipidemia;

  7. Contraindication to rosuvastatin;

    1. Known hypersensitivity or intolerance to statins;
    2. History of muscle disorders or statin-related muscle pain;
    3. Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver);
    4. Chronic kidney disease (creatinine clearance < 30ml/min);
    5. Currently pregnant or breast feeding;
    6. Taking cyclosporine;
    7. Taking atazanavir/ritonavir;
    8. Taking darolutamide;
    9. Taking regorafenib;
  8. Unstable medical or psychological condition that would interfere with trial participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rosuvastatin
Participants 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.
Drug: Rosuvastatin Calcium
Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
Other Names:
  • Rosuvastatin
Placebo Comparator: Placebo
Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.
Drug: Placebo Oral Tablet
Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrent Major VTE
Time Frame: Up to 60 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post Thrombotic Syndrome
Time Frame: Up to 60 months

Post-thrombotic syndrome as measured by the Villalta scale throughout the follow-up period in patients taking generic rosuvastatin as compared with placebo. The Villalta PTS scale has been adopted by the International Society on Thrombosis and Haemostasis (ISTH) as a standard to diagnose and grade the severity of PTS in clinical studies.

Points are summed to yield total score: 0-4: No PTS; 5-9: Mild PTS; 10-14: Moderate PTS; 15 or more, or presence of ulcer: Severe PTS.
Up to 60 months
Number of participants diagnosed with non-major VTE during follow-up
Time Frame: Up to 60 months

Symptomatic non-major VTE (see below) occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin as compared with placebo.

Non-major VTE:

  • Distal DVT (distal to the trifurcation of the popliteal vein);
  • Isolated sub-segmental PE;
  • Upper extremity DVT;
  • Superficial phlebitis > 5 cm;
  • Superficial phlebitis ≤ 5 cm.
Up to 60 months
Number of participants diagnosed with an arterial vascular event during follow-up
Time Frame: Up to 60 months

Components of composite arterial vascular events (see below) occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin as compared with placebo.

Components of composite arterial vascular events:

  • Fatal myocardial infarction;
  • Non-fatal myocardial infarction;
  • Hospitalization for unstable angina;
  • Coronary artery revascularization;
  • Sudden cardiac death;
  • Ischemic stroke.
Up to 60 months
Number of deaths during study participation
Time Frame: Up to 60 months
All-cause mortality 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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants who have a bleeding event during follow-up
Time Frame: Up to 60 months
Bleeding event (major, clinically relevant non-major, minor) 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
British Heart Foundation
Programme hospitalier de recherche clinique, France
Eastern Norway Health Authorities RHF
Southern health region, Norway

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aurélien Delluc, MD, Ottawa Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAVER Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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