Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Last updated: May 30, 2023
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Recruiting

Phase

3

Condition

Thromboembolism

Thrombosis

Deep Vein Thrombosis

Treatment

Rosuvastatin Calcium

Placebo Oral Tablet

Clinical Study ID

NCT04319627
SAVER Trial
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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:

  6. Diabetes;

  7. Abdominal aortic aneurysm;

  8. Peripheral arterial disease;

  9. Stroke;

  10. Transient ischemic attack (TIA);

  11. Myocardial infarction (MI);

  12. Acute coronary syndromes;

  13. Stable/unstable angina;

  14. Coronary or other arterial revascularization;

  15. Known diagnosis of hypercholesterolemia or dyslipidemia;

  16. Contraindication to rosuvastatin;

  17. Known hypersensitivity or intolerance to statins;

  18. History of muscle disorders or statin-related muscle pain;

  19. Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver);

  20. Chronic kidney disease (creatinine clearance < 30ml/min);

  21. Currently pregnant or breast feeding;

  22. Taking cyclosporine;

  23. Taking atazanavir/ritonavir;

  24. Taking darolutamide;

  25. Taking regorafenib;

  26. Unstable medical or psychological condition that would interfere with trial participation.

Study Design

Total Participants: 2700
Treatment Group(s): 2
Primary Treatment: Rosuvastatin Calcium
Phase: 3
Study Start date:
February 10, 2021
Estimated Completion Date:
January 31, 2027

Study 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.

Connect with a study center

  • Foothills Medical Centre

    Calgary, Alberta T2N 2T9
    Canada

    Active - Recruiting

  • Queen Elizabeth II Hospital

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Active - Recruiting

  • Juravinski Hospital

    Hamilton, Ontario L8V 1C3
    Canada

    Active - Recruiting

  • St. Joseph's Healthcare

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Hôpital Montfort

    Ottawa, Ontario K1K 0T2
    Canada

    Active - Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Niagara Health - St. Catharines Site

    St. Catharines, Ontario L2S 0A9
    Canada

    Active - Recruiting

  • Sunnybrook Hospital

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • University Health Network

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • McGill Univeristy Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • CHU de Quebec-Université Laval

    Quebec City, Quebec G1V 4G2
    Canada

    Active - Recruiting

  • Brest University Hospital Centre

    Brest,
    France

    Site Not Available

  • Mater Misericordiae University Hospital

    Dublin,
    Ireland

    Site Not Available

  • University of Insubria

    Varese,
    Italy

    Site Not Available

  • Amsterdam University

    Amsterdam, Holland 1098XH
    Netherlands

    Site Not Available

  • Ostfold Hopsital

    Sarpsborg,
    Norway

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.