Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Thromboembolism Blood Clot Post Thrombotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Rosuvastatin Calcium

Intervention Type DRUG

Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.

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.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.

Interventions

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Rosuvastatin Calcium

Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Rosuvastatin Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aurélien Delluc, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

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Canada France Ireland Italy Norway United Kingdom

Central Contacts

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Jennifer Brinkhurst

Role: CONTACT

[email protected]

613-737-8899

OHRI Clinical Research Quality Team

Role: CONTACT

[email protected]

Facility Contacts

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Jennifer Brinkhurst

Role: primary

[email protected]

Sven Arne Sogn

Role: primary

Other Identifiers

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SAVER Trial

Identifier Type: -

Identifier Source: org_study_id

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Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis

Statins to Reduce D-dimer Levels in Patients With Venous Thrombosis

Rosuvastatin Use to Improve the Coagulation Profile in Patients With Venous Thrombosis

Treatment for Blood Clots in the Veins of the Legs

Statins to Prevent Cancer Associated Blood Clots

Detailed Description

Conditions

Study Design

Study Groups

Rosuvastatin

Rosuvastatin Calcium

Placebo

Placebo Oral Tablet

Interventions

Rosuvastatin Calcium

Placebo Oral Tablet

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Canadian Institutes of Health Research (CIHR)

Eastern Norway Health Authorities RHF

Southern health region, Norway

Programme hospitalier de recherche clinique, France

British Heart Foundation

Ottawa Hospital Research Institute

Responsible Party

Principal Investigators

Aurélien Delluc, MD

Locations

Foothills Medical Centre

Queen Elizabeth II Hospital

Hamilton General Hospital

St. Joseph's Healthcare

Juravinski Hospital

The Ottawa Hospital

Hôpital Montfort

Niagara Health - St. Catharines Site

Sunnybrook Hospital

University Health Network

Jewish General Hospital

McGill Univeristy Health Centre

CIUSSS de-l'Ouest-de-l'Ile-de-Montreal -St. Mary's Hospital Center

CHU de Quebec-Université Laval

CHU d'Angers - Service d'accueil et traitement des Urgences

Brest University Hospital Centre

CHU de Clermont-Ferrand, Hôpital Gabriel Montpied

APHP Hôpital Louis Mourier

CHU de Dijon - Service d'imagerie diagnostique et thérapeutique

GH La Rochelle - Ré-Aunis - Service de Médecine vasculaire

Centre Hospitalier Universitaire De Saint Etienne

CHI Toulon - La Seyne sur Mer - Hôpital Sainte Musse

Mater Misericordiae University Hospital

University of Insubria

Ostfold Hopsital

Aberdeen Royal Infirmary

Queen Elizabeth Hospital

University Hospital of Wales

Glasgow Royal Infirmary

King's College Hospital NHS Foundation Trust

Oxford University Hospitals NHS Foundation Trust

Countries

Central Contacts

Jennifer Brinkhurst

OHRI Clinical Research Quality Team

Facility Contacts

Jennifer Brinkhurst

Sven Arne Sogn

Other Identifiers

SAVER Trial

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