Statins for Venous Event Reduction in Patients With Venous Thromboembolism (SAVER)
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ClinicalTrials.gov Identifier: NCT04319627 |
Recruitment Status :
Recruiting
First Posted : March 24, 2020
Last Update Posted : September 22, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Venous Thromboembolism Blood Clot Post Thrombotic Syndrome | Drug: Rosuvastatin Calcium Drug: Placebo Oral Tablet | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2700 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Statins for Venous Event Reduction in Patients With Venous Thromboembolism |
Actual Study Start Date : | February 10, 2021 |
Estimated Primary Completion Date : | January 2026 |
Estimated Study Completion Date : | January 2027 |

Arm | Intervention/treatment |
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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.
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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 Name: 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.
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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 Name: Placebo |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- 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;
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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;
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319627
Contact: Jennifer Brinkhurst | +16137378899 ext 71068 | jbrinkhurst@ohri.ca |
Canada, Nova Scotia | |
Queen Elizabeth II Hospital | Recruiting |
Halifax, Nova Scotia, Canada, B3H 2Y9 | |
Principal Investigator: Sudeep Shivakumar, MD | |
Canada, Ontario | |
Hamilton General Hospital | Recruiting |
Hamilton, Ontario, Canada, L8L 2X2 | |
Principal Investigator: Sam Schulman, MD | |
St. Joseph's Healthcare | Not yet recruiting |
Hamilton, Ontario, Canada, L8N 4A6 | |
Principal Investigator: Jim Douketis, MD | |
Juravinski Hospital | Recruiting |
Hamilton, Ontario, Canada, L8V 1C3 | |
Principal Investigator: Peter Gross, MD | |
The Ottawa Hospital | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Jennifer Brinkhurst 6137378899 ext 71068 jbrinkhurst@ohri.ca | |
Principal Investigator: Aurélien Delluc, MD | |
Sunnybrook Hospital | Not yet recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Principal Investigator: Jean-Philippe Galanaud, MD | |
University Health Network | Not yet recruiting |
Toronto, Ontario, Canada, M5G 2C4 | |
Principal Investigator: Erik Yeo, MD | |
Canada, Quebec | |
Jewish General Hospital | Recruiting |
Montreal, Quebec, Canada, H3T 1E2 | |
Principal Investigator: Susan Kahn, MD | |
McGill Univeristy Health Centre | Recruiting |
Montreal, Quebec, Canada, H4A 3J1 | |
Principal Investigator: Véronique Naessens, MD | |
CHU de Quebec-Université Laval | Recruiting |
Quebec City, Quebec, Canada, G1V 4G2 | |
Principal Investigator: Guillaume Roberge, MD | |
France | |
Brest University Hospital Centre | Not yet recruiting |
Brest, France | |
Principal Investigator: Raphael Le Mao, MD | |
Ireland | |
Mater Misericordiae University Hospital | Not yet recruiting |
Dublin, Ireland | |
Principal Investigator: Fionnuala Ní Áinle, MD | |
Italy | |
University of Insubria | Not yet recruiting |
Varese, Italy | |
Principal Investigator: Walter Ageno, MD | |
Netherlands | |
Amsterdam University | Not yet recruiting |
Amsterdam, Holland, Netherlands, 1098XH | |
Principal Investigator: Michiel Coppens, MD | |
Norway | |
Ostfold Hopsital | Not yet recruiting |
Sarpsborg, Norway | |
Contact: Christina Roaldsnes Christina.Roaldsnes@so-hf.no | |
Principal Investigator: Waleed Ghanima, MD |
Principal Investigator: | Aurélien Delluc, MD | Ottawa Hospital Research Institute |
Responsible Party: | Ottawa Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT04319627 |
Other Study ID Numbers: |
SAVER Trial |
First Posted: | March 24, 2020 Key Record Dates |
Last Update Posted: | September 22, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Rosuvastatin Statin PTS VTE |
Thromboembolism Venous Thromboembolism Thrombosis Postthrombotic Syndrome Postphlebitic Syndrome Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Venous Thrombosis Venous Insufficiency Phlebitis Peripheral Vascular Diseases |
Rosuvastatin Calcium Calcium Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |