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StAtins for Venous Event Reduction in Patients With Venous Thromboembolism Pilot Study (SAVER)

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ClinicalTrials.gov Identifier: NCT02679664
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

The SAVER pilot is a randomized, open-label pilot study to determine the feasibility of recruitment. In addition to feasibility data, the investigators will carefully collect clinical data to determine if rosuvastatin can reduce post-thrombotic syndrome (PTS) in venous thromboembolism (VTE) patients.

Eligible consenting patients who developed acute, symptomatic, and objectively confirmed proximal leg deep vein thrombosis (DVT) and/or PE will be randomized and equally allocated to 2 trial arms, either the treatment group (rosuvastatin tablet (20 mg/day) or the control group (usual care). The pilot trial consists of up to 4 study contacts over 6 months: screening, randomization, telephone follow-up (90 days), and final study visit (180 days).


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Rosuvastatin Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: StAtins for Venous Event Reduction in Patients With Venous Thromboembolism: A Pilot Study Assessing Feasibility of an RCT to Evaluate if Generic Rosuvastatin Reduces the Risk of Recurrent VTE in Patients With Symptomatic Major VTE.
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
20 mg tablet of rosuvastatin PO once-a-day starting at the time of randomization until the completion of follow-up at 6 months.
Drug: Rosuvastatin
20 mg tablet of rosuvastatin
Other Names:
  • Generic rosuvastatin
  • Teva-Rosuvastatin

No Intervention: Control group
Standard medical care only. No rosuvastatin group.



Primary Outcome Measures :
  1. Number of participants recruited per center per month - [Study Feasibility] [ Time Frame: 3 years ]
    Study feasibility as indicated by the number of participants recruited per center per month.

  2. Incidence of PTS [ Time Frame: 180 days (+/- 21 days) ]
    Incidence of post thrombotic syndrome (PTS), as measured by the Villalta scale at 6 months by both an 'Blinded Independent Assessor' and self reported by the participant.


Secondary Outcome Measures :
  1. Symptomatic recurrent major VTE [ Time Frame: 180 days (+/- 21 days) ]
    Symptomatic recurrent major VTE (proximal DVT or segmental or larger PE) in patients taking generic rosuvastatin (full trial primary outcome). Coordinators will submit a report to the independent adjudication committee for participants that undergo investigation for suspected recurrent VTE during the study.

  2. Components of major VTE [ Time Frame: 180 days (+/- 21 days) ]
    1. Proximal DVT
    2. Segmental or greater PE

  3. Non-major VTE [ Time Frame: 180 days (+/- 21 days) ]
    1. Distal DVT(distal to the trifurcation of the popliteal vein)
    2. Isolated sub-segmental PE
    3. Superficial phlebitis > 5 cm
    4. Superficial phlebitis ≤ 5 cm

  4. Arterial Vascular Events [ Time Frame: 180 days (+/- 21 days) ]

    At the 3-month call and 6-month visit the research coordinator will follow an interview script to screen for inter-current suspected arterial events. Any reported potential arterial events will trigger a more in-depth evaluation.

    1. Fatal myocardial infarction
    2. Non-fatal myocardial infarction
    3. Hospitalization for unstable angina
    4. Coronary artery revascularization
    5. Sudden cardiac death
    6. Ischemic stroke

  5. All-cause mortality [ Time Frame: 180 days (+/- 21 days) ]
    All-cause mortality

  6. Bleeding [ Time Frame: 180 days (+/- 21 days) ]
    At each follow-up visit the research coordinator will follow an interview script to screen for suspected major and clinically relevant non-major bleeding events. Suspected bleeding that lasts more than 10 minutes, required intervention to control or for which the patient sought medical attention will be adjudicated by an independent committee using ISTH bleeding criteria.

  7. Muscle Toxicity [ Time Frame: 180 days (+/- 21 days) ]
    Participants reporting symptoms of muscle toxicity will have their CK levels tested for safety. Study drug will be discontinued if CK levels are markedly elevated (>10 x ULN)



Information from the National Library of Medicine

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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 medical history or current diagnosis of any of the following:

    • Abdominal aortic aneurysm,
    • Peripheral arterial disease,
    • Stroke,
    • Transient ischemic attack (TIA),
    • Myocardial infarction (MI),
    • Acute coronary syndromes,
    • Stable angina,
    • Coronary or other arterial revascularization
  5. LDL-C >4.91 mmol/L
  6. LDL-C between 1.81mmol/L to 4.9mmol/L AND 10 ASCVD risk score >10%
  7. Diabetes mellitus or pre-diabetes
  8. Contraindication to rosuvastatin;

    • Hypersensitivity or intolerance to statins;
    • History of muscle disorders or statin-related muscle pain;
    • 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)
    • Currently pregnant or breast feeding;
    • Taking cyclosporine.
  9. Life expectancy less than 3 months, as judged by the investigator
  10. 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): NCT02679664


Contacts
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Contact: Marc Rodger, M.D. 613-737-8899 ext 74640 mrodger@ohri.ca
Contact: Anne Marie Clement 613-737-8899 ext 73389 amclement@ohri.ca

Locations
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Canada, Nova Scotia
Nova Scotia health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Principal Investigator: Sudeep Shivakumar, MD, FRCPC         
Canada, Ontario
Hamilton Health Sciences Corporation Recruiting
Hamilton, Ontario, Canada, L8L 8E7
Principal Investigator: Clive Kearon, MB, MRCPI, FRCPC, PhD         
Lawson Health Research Institute, London Health Sciences Centre Recruiting
London, Ontario, Canada, N6C 2R5
Principal Investigator: Michael Kovacs, MD         
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Marc Rodger, MD    613-798-5555 ext 74641    mrodger@ohri.ca   
Canada, Quebec
Sir Mortimer B. Davis Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Dr. Susan Kahn, MD, FRCPC, MSc         
Principal Investigator: Susan Kahn, MD, FRCPC, MSc         
Norway
Østfold Hospital Trust Recruiting
Grålum, Norway
Contact: Dr. Waleed Ghanima, MD, Ph.D.         
Contact: Christina Roaldsness    +47 41267921    Christina.Roaldsnes@so-hf.no   
Principal Investigator: Waleed Ghanima, M.D, Ph.D.         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Marc Rodger, M.D. Ottawa Hospital Research Institute

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02679664     History of Changes
Other Study ID Numbers: 20160047-01H
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors