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Trial record 4 of 72 for:    SAVER

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679664
Recruitment Status : Active, not recruiting
First Posted : February 10, 2016
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE February 1, 2016
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date February 27, 2020
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date January 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
Primary feasibility outcome [ Time Frame: 6 months ]
Study feasibility as indicated by the number of participants recruited per center per month.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • 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.
  • Components of major VTE [ Time Frame: 180 days (+/- 21 days) ]
    1. Proximal DVT
    2. Segmental or greater PE
  • 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
  • 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
  • All-cause mortality [ Time Frame: 180 days (+/- 21 days) ]
    All-cause mortality
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
  • Incidence of PTS [ Time Frame: 6 months ]
    Incidence of post thrombotic syndrome (PTS), as measured by the Villalta scale at 6 months.
  • Symptomatic recurrent major VTE [ Time Frame: 6 months ]
    Symptomatic recurrent major VTE (proximal DVT or segmental or larger PE) in patients taking generic rosuvastatin (full trial primary outcome).
  • Components of major VTE [ Time Frame: 6 month ]
    1. Proximal DVT
    2. Segmental or greater PE
  • Non-major VTE [ Time Frame: 6 month ]
    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
  • Arterial Vascular Events [ Time Frame: 6 month ]
    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
  • All-cause mortality [ Time Frame: 6 month ]
    All-cause mortality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE StAtins for Venous Event Reduction in Patients With Venous Thromboembolism Pilot Study
Official Title  ICMJE 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.
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).

Detailed Description

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.

  • SCREENING: Research coordinators at each pilot site will screen patients for eligibility and will complete detailed logs of all patients meeting inclusion (both enrolled and excluded). After providing informed consent, eligibility will be confirmed by the following tests : a lipid profile, A1C test/ CBC, transaminase (ALT) levels, Creatinine and pregnancy test (if a female of child bearing potential). Consenting participants who (following screening) do not meet eligibility criteria will be followed up to establish feasibility outcomes.
  • RANDOMIZATION: Randomization will be conducted using an Interactive Web based Randomization System in a 1:1 ratio for treatment (20mg rosuvastatin od) or control (no study drug).
  • STUDY DRUG DISPENSING: Participants randomized to the treatment arm will be dispensed x 200 20mg tablets of rosuvastatin along with a medication diary.They will be educated on study drug dosing regimen (20mg tablet od), how to complete their medication diary and on the possible side-effects of rosuvastatin. They will be advised to contact either the study coordinator, investigator or go directly to the emergency department should they experience any symptoms in particular anything muscle related.
  • BASELINE. Assessments include;

    • Demographic data;
    • Concomitant medications (antiplatelet, anti-inflammatories, anticoagulation);
    • Type of index VTE;
    • PTS Villalta leg assessment conducted by both the participant (Patient Reported Villalta [PRV] questionnaire) and a qualified blinded independent observer (The Villalta scale is the most extensively validated tool and is recommended by the ISTH) - (Primary Outcome);
    • Risk factors for recurrent VTE, bleeding and arterial vascular events;
    • Medical history including prior VTE, Arterial disease, Liver disease and Glucose Intolerance.
  • 90 DAY FOLLOW UP [Treatment arm only]: Participants randomized to treatment will be followed up via telephone or email at 90 days (+/- 21 days);

    • Participants will be asked questions to screen for;

      • Study outcomes: Suspected VTE, Arterial, Bleeding and/ or Muscle Events Patients who report any unexplained muscle symptoms will be asked to have their Creatine kinase (CK) levels tested within 2 weeks of reporting the symptoms. Study drug will be discontinued if CK levels are markedly elevated (> 10 x ULN).;
      • Study Drug compliance
      • Adverse events.
      • Concomitant medication will be reviewed in case of any contraindications. Changes or additions in concomitant anticoagulation therapy, anti-platelet or anti - inflammatory medication will also be recorded.
    • Study coordinators will log all follow up contact attempts.
  • FINAL STUDY VISIT (180 days (+/- 21 days): All study participants will be asked to attend an in person study visit at 180 days (+/-21) for;

    • Follow-up of study outcomes; VTE, Arterial, Bleeding and Muscle events;
    • Study drug compliance;
    • Relevant (S)AE(s).
    • Repeat PTS leg assessment (using the Villalta scale) both by a qualified independent observer and the participant (Primary outcome);
    • Study drug compliance: Medication Diaries and used medication bottles will be collected by the study coordinator. Coordinator will perform a pill count and reconcile with the participants medication diary. Coordinator will also ask participant reasons for any missed doses.

ADJUDICATION OF STUDY OUTCOMES: All Bleeding, VTE and Arterial Suspected Events as well as deaths will be recorded on a suspected event CRF along with any diagnostic imaging/ tests and will trigger a more in-depth evaluation, and review by an independent adjudication committee.

ADVERSE EVENTS: AEs will be elicited, monitored and recorded throughout the study.

All events meeting the definition of an SAE (as per ICH-GCP) must be reported to the SAVER Trial Office in Ottawa, Canada within 24 h of awareness.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE Drug: Rosuvastatin
20 mg tablet of rosuvastatin
Other Names:
  • Generic rosuvastatin
  • Teva-Rosuvastatin
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Rosuvastatin
  • No Intervention: Control group
    Standard medical care only. No rosuvastatin group.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 5, 2016)
312
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Actual Primary Completion Date January 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02679664
Other Study ID Numbers  ICMJE 20160047-01H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc Rodger, M.D. Ottawa Hospital Research Institute
PRS Account Ottawa Hospital Research Institute
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP