Deep Vein Thrombosis, Pulmonary Embolism, Venous thromboembolism
Conditions
Brief summary
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.
Detailed description
Post-thrombotic syndrome as measured by the Villalta score, Non-major VTE; a) Distal DVT (distal to the trifurcation of the popliteal vein); b) Isolated sub-segmental PE; c) Upper Extremity DVT; d) Unusual site DVT; e) Superficial vein thrombosis, 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 (no adjudication required)
Interventions
DRUGPlacebo Rosuvastatin Calcium 20 mg tablets
Sponsors
Centre Hospitalier Regional Et Universitaire De Brest, Ostfold Hospital Trust, Ottawa Hospital Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Post-thrombotic syndrome as measured by the Villalta score, Non-major VTE; a) Distal DVT (distal to the trifurcation of the popliteal vein); b) Isolated sub-segmental PE; c) Upper Extremity DVT; d) Unusual site DVT; e) Superficial vein thrombosis, 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 (no adjudication required) | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France, Norway
Outcome results
None listed