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Venous ThromboembolismPhase 3SAVERNCT04319627

Statins for Venous Event Reduction in Patients With Venous Thromboembolism

A Phase 3 study testing Rosuvastatin Calcium in people with Venous Thromboembolism and Blood Clot, run by Ottawa Hospital Research Institute at 31 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rosuvastatin Calcium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,700 participants
Where
31 sitesin 6 countries
Study dates
10 Feb 2021to Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 26Show fewer
  • 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;
  • Contraindication to rosuvastatin;
  • Known hypersensitivity or intolerance to statins;
  • History of muscle disorders or statin-related muscle pain;
  • Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver);
  • Chronic kidney disease (creatinine clearance < 30ml/min);
  • Currently pregnant or breast feeding;
  • Taking cyclosporine;
  • Taking atazanavir/ritonavir;
  • Taking darolutamide;
  • Taking regorafenib;
  • Unstable medical or psychological condition that would interfere with trial participation.

Trial locations and contacts

31 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Jennifer Brinkhurst contact

613-737-8899

jbrinkhurst@ohri.ca

OHRI Clinical Research Quality Team contact

CRQuality@ohri.ca

31 sites in 6 countries

Canada14 sites, 11 recruiting

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

    Leslie Skeith, MD

    Recruiting

  • Queen Elizabeth II Hospital

    Halifax, Nova Scotia, B3H 2Y9

    Withdrawn

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

    Sam Schulman, MD

    Recruiting

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

    Jim Douketis, MD

    Recruiting

  • Juravinski Hospital

    Hamilton, Ontario, L8V 1C3

    Withdrawn

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Susan Kahn, MD

    Recruiting

  • McGill Univeristy Health Centre

    Montreal, Quebec, H4A 3J1

    Véronique Naessens, MD

    Recruiting

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

    Montreal, Quebec, H9R 2Y2

    Carolyne Elbaz, MD

    Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

    Jennifer Brinkhurst, jbrinkhurst@ohri.ca

    Aurélien Delluc, MD

    Recruiting

  • Hôpital Montfort

    Ottawa, Ontario, K1K 0T2

    Withdrawn

  • CHU de Quebec-Université Laval

    Québec, Quebec, G1V 4G2

    Guillaume Roberge, MD

    Recruiting

  • Niagara Health - St. Catharines Site

    St. Catharines, Ontario, L2S 0A9

    Blair Leonard, MD

    Recruiting

  • Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

    Jean-Philippe Galanaud, MD

    Not yet recruiting

  • University Health Network

    Toronto, Ontario, M5G 2C4

    Erik Yeo, MD

    Recruiting

Other trials in Canada

France8 sites, 8 recruiting

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

    Angers

    Jeane Hersant

    Recruiting

  • Brest University Hospital Centre

    Brest

    Raphael Le Mao, MD

    Recruiting

  • CHU de Clermont-Ferrand, Hôpital Gabriel Montpied

    Clermont-Ferrand

    Jeanot Schmidt, MD

    Recruiting

  • APHP Hôpital Louis Mourier

    Colombes

    Isabelle Mahe

    Recruiting

  • CHU de Dijon - Service d'imagerie diagnostique et thérapeutique

    Dijon

    Nicolas Falvo

    Recruiting

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

    La Rochelle

    Christophe Roncato

    Recruiting

  • Centre Hospitalier Universitaire De Saint Etienne

    Saint-Etienne

    Laurant Bertoletti, MD

    Recruiting

  • CHI Toulon - La Seyne sur Mer - Hôpital Sainte Musse

    Toulon

    Jean-Noël Poggi

    Recruiting

Other trials in France

United Kingdom6 sites, 6 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen

    Mary-Joan Macleod

    Not yet recruiting

  • Queen Elizabeth Hospital

    Birmingham

    Gillian Lowe

    Not yet recruiting

  • University Hospital of Wales

    Cardiff

    Raza Alikhan

    Not yet recruiting

  • Glasgow Royal Infirmary

    Glasgow

    Catherine Bagot

    Not yet recruiting

  • King's College Hospital NHS Foundation Trust

    London

    Lara Roberts

    Not yet recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford

    Nicola Curry

    Not yet recruiting

Other trials in United Kingdom

Ireland1 site, 1 recruiting

  • Mater Misericordiae University Hospital

    Dublin

    Fionnuala Ní Áinle, MD

    Not yet recruiting

Other trials in Ireland

Italy1 site, 1 recruiting

  • University of Insubria

    Varese

    Walter Ageno, MD

    Not yet recruiting

Other trials in Italy

Norway1 site, 1 recruiting

  • Ostfold Hopsital

    Sarpsborg

    Sven Arne Sogn

    Waleed Ghanima, MD

    Recruiting

Other trials in Norway

About this study

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.

Read more

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.

Read the 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.
Being tested
Rosuvastatin Calcium, Placebo Oral Tablet
Keywords
Rosuvastatin, Statin, PTS, VTE
Medical subject headings
Venous Thromboembolism, Thrombosis, Postthrombotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rosuvastatin CalciumDrug

    Also called Rosuvastatin

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

  • Placebo Oral TabletDrug

    Also called Placebo

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

Study groups in NCT04319627
Study groupRoleWhat they receive
RosuvastatinExperimentalParticipants 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.
Receives: Drug: Rosuvastatin Calcium
PlaceboPlacebo comparatorParticipants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 60 months

Secondary outcomes (4)

  1. Post Thrombotic Syndrome

    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.

    Measured: Up to 60 months

  2. Number of participants diagnosed with non-major VTE during follow-up

    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.

    Measured: Up to 60 months

  3. Number of participants diagnosed with an arterial vascular event during follow-up

    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.

    Measured: Up to 60 months

  4. Number of deaths during study participation

    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.

    Measured: Up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2020
  2. Study start10 Feb 2021
  3. Primary completionJan 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04319627
Sponsor's protocol ID
SAVER Trial
Acronym
SAVER
Status last verified
Jan 2026
First submitted
20 Mar 2020
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosuvastatin Calcium in people with Venous Thromboembolism and Blood Clot, run by Ottawa Hospital Research Institute at 31 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Canada, France, United Kingdom, Ireland, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Brinkhurst (613-737-8899, jbrinkhurst@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrent Major VTE (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04319627.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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