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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 : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Blood Clot Post Thrombotic Syndrome Drug: Rosuvastatin Calcium Drug: Placebo Oral Tablet Phase 3

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Currently prescribed a statin;
  4. A known medical history or current diagnosis of any of the following:

    • Diabetes,
    • Abdominal aortic aneurysm,
    • Peripheral arterial disease presumed to be of atherosclerotic origin,
    • Stroke,
    • Transient ischemic attack (TIA),
    • Myocardial infarction (MI),
    • Acute coronary syndromes,
    • Stable/unstable angina,
    • Coronary or other arterial revascularization;
  5. Known diagnosis of hypercholesterolemia or dyslipidemia;
  6. Contraindication to rosuvastatin:

    • Known hypersensitivity or intolerance to statins,
    • History of muscle disorders or statin-related muscle pain,
    • Known liver disease (active liver disease or unexplained elevations of serum transaminases exceeding 3 times the upper limit of normal),
    • Chronic kidney disease (Creatinine clearance < 30ml/min within previous 3 months),
    • Currently pregnant or breast-feeding,
    • Taking cyclosporine;
  7. Unstable medical or psychological condition that would interfere with trial participation.

Information from the National Library of Medicine

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


Contacts
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Contact: Lesley Yeung +16137378899 ext 71068 lyeung@ohri.ca
Contact: Penny Phillips +16137378899 ext 73440 pphillips@ohri.ca

Locations
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Canada, Ontario
Hamilton General Hospital Not yet 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 Not yet recruiting
Hamilton, Ontario, Canada, L8V 1C3
Principal Investigator: Peter Gross, MD         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Lesley Yeung    6137378899 ext 71068    lyeung@ohri.ca   
Principal Investigator: Aurélien Delluc, MD         
Canada, Quebec
Jewish General Hospital Not yet recruiting
Montreal, Quebec, Canada, H3T 1E2
Principal Investigator: Susan Kahn, MD         
McGill Univeristy Health Centre Not yet recruiting
Montreal, Quebec, Canada, H4A 3J1
Principal Investigator: Véronique Naessens, MD         
CHU de Quebec-Université Laval Not yet recruiting
Quebec City, Quebec, Canada, G1V 4G2
Principal Investigator: Guillaume Roberge, MD         
France
Brest University Hospital Centre Not yet recruiting
Brest, France
Principal Investigator: Karine Lacut, 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: Nick Van Es, MD         
Norway
Ostfold Hopsital Not yet recruiting
Sarpsborg, Norway
Contact: Christina Roaldsnes       Christina.Roaldsnes@so-hf.no   
Principal Investigator: Waleed Ghanima, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Aurélien Delluc, MD Ottawa Hospital Research Institute
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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: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ottawa Hospital Research Institute:
Rosuvastatin
Statin
PTS
VTE
Additional relevant MeSH terms:
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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