blood clot in vein of the leg Venous thrombosis
Conditions
Interventions
After informed consent, participants will be screened on acquired risk factors
for thrombosis through a questionnaire and tested on blood parameters that may
exclude a particpant from taking rosuvas
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Persons with venous thrombosis who are allowed to discontinue oral anticoagulant treatment by their treating physician and do not receive a statin.
Exclusion criteria
Exclusion criteria: Persons already using statins or lipid lowering drugs History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin Pregnancy Current active liver disease Kidney disease Mental or physical disability to fulfil study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: The primary objective of this study will be to demonstrate that 28 days of rosuvastatin 20 mg once daily treatment will improve the coagulation profile in persons who had venous thrombosis. Coagulation profile includes: thrombin generation, factor VIII, fibrinogen, von Willebrand factor, protein C, protein S, antithrombin, TAT and fragment 1,2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): To investigate whether the effect on coagulation factors are correlated with changes in levels of markers of endothelial activation and inflammation. We will also assess potential effect modification of rosuvastatin on coagulation factors by genes involved in coagulation regulation. Endothelium and inflammation: IL-6, IL-8, CRP, soluble P-selectin, trombomodulin and EPCR. Genetic variants: rs6025 (factor V Leiden), rs1799963 (prothrombin G20210A), ABO blood group, rs2066865 (FGG 10034 C>T) and rs2289252 (F11) Acquired risk factors: (hormone use, surgery, malignancy, etc) | — |
Countries
Netherlands
Outcome results
None listed