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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
20 mg tablet of rosuvastatin
No Intervention: Control group
Standard medical care only. No rosuvastatin group.
- 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.
- 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) ]
- Proximal DVT
- Segmental or greater PE
- Non-major VTE [ Time Frame: 180 days (+/- 21 days) ]
- Distal DVT(distal to the trifurcation of the popliteal vein)
- Isolated sub-segmental PE
- Superficial phlebitis > 5 cm
- 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.
- Fatal myocardial infarction
- Non-fatal myocardial infarction
- Hospitalization for unstable angina
- Coronary artery revascularization
- Sudden cardiac death
- 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)
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
|Contact: Marc Rodger, M.D.||613-737-8899 ext email@example.com|
|Contact: Anne Marie Clement||613-737-8899 ext firstname.lastname@example.org|
|Canada, Nova Scotia|
|Nova Scotia health Authority||Recruiting|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Principal Investigator: Sudeep Shivakumar, MD, FRCPC|
|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, Ontario, Canada, K1H 8L6|
|Contact: Marc Rodger, MD 613-798-5555 ext 74641 email@example.com|
|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|
|Østfold Hospital Trust||Recruiting|
|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.|
|Principal Investigator:||Marc Rodger, M.D.||Ottawa Hospital Research Institute|