MedDRA version: 21.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Product Name: Rosuvastatin calcium
Pharmaceutical Form: Tablet
INN or Proposed INN: ROSUVASTATIN CALCIUM
Other descriptive name: ROSUVASTATIN CALCIUM
Concentration unit: mg milligram(s)
Concentration
Sponsors
Ottawa Hospital Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 700
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to provide written informed consent; 2. = 18 years of age; 3. Women of childbearing potential1 unwilling to use appropriate contraception2; 4. Currently prescribed a statin; 5. 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. 6. Known diagnosis of hypercholesterolemia or dyslipidemia; 7. 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; ? Taking atazanavir/ritonavir. 8. Unstable medical or psychological condition that would interfere with trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the primary outcome event rate in patients taking generic rosuvastatin compared to placebo.;Secondary Objective: 1.To determine the major bleeding event rate in patients taking generic rosuvastatin compared to placebo. 2.To explore if rosuvastatin reduces the incidence of PTS, as measured by the Villalta scale at end of study.;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: Between randomization of the first patient and end of study - maximum 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Post-thrombotic syndrome as measured by the Villalta score; ? Non-major VTE; o Distal DVT (distal to the trifurcation of the popliteal vein); o Isolated sub-segmental PE; o Upper Extremity DVT; o Unusual site DVT o Superficial phlebitis > 5 cm; o Superficial phlebitis = 5 cm; ? Components of composite arterial vascular events; o Fatal myocardial infarction; o Non-fatal myocardial infarction; o Hospitalization for unstable angina; o Coronary artery revascularization; o Sudden cardiac death; o Ischemic stroke. ? All-cause mortality (adjudication not required). ;Timepoint(s) of evaluation of this end point: Between randomisation of the first patient and end of study, last patient last visit - maximum 5 years. | — |
Countries
Australia, Canada, France, Italy, Netherlands, Norway
Contacts
Public ContactWaleed Ghanima
Østfold Hospital Trust
Outcome results
None listed