Rosuvastatin use to improve the coagulation profile in patients with venous thrombosis: The STAtins Reduce Thrombophilia (START) Study

Completed

Conditions: 10014523
blood clot in vein of the leg
Venous thrombosis
10064477
10011082

Registration Number: NL-OMON39948

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 250

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br>The primary objective of this study will be to demonstrate that 28 days of<br /><br>rosuvastatin 20 mg once daily treatment will improve the coagulation profile in<br /><br>persons who had venous thrombosis.<br /><br><br /><br>Coagulation profile includes: thrombin generation, factor VIII, fibrinogen, von<br /><br>Willebrand factor, protein C, protein S, antithrombin, TAT and fragment 1,2 </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s):<br /><br>To investigate whether the effect on coagulation factors are correlated with<br /><br>changes in levels of markers of endothelial activation and inflammation. We<br /><br>will also assess potential effect modification of rosuvastatin on coagulation<br /><br>factors by genes involved in coagulation regulation.<br /><br><br /><br>Endothelium and inflammation: IL-6, IL-8, CRP, soluble P-selectin,<br /><br>trombomodulin and EPCR.<br /><br><br /><br>Genetic variants: rs6025 (factor V Leiden), rs1799963 (prothrombin G20210A),<br /><br>ABO blood group, rs2066865 (FGG 10034 C>T) and rs2289252 (F11)<br /><br><br /><br>Acquired risk factors: (hormone use, surgery, malignancy, etc) </p><br>