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Clinical Trials/NCT01613794
NCT01613794
Completed
Not Applicable

Prospective Randomized Controlled, Open Label, Clinical Trial to Study if Rosuvastatin Use Improves the Coagulation Profile in Patients With Venous Thrombosis

Leiden University Medical Center3 sites in 1 country255 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Rosuvastatin
Conditions
Deep Vein Thrombosis
Sponsor
Leiden University Medical Center
Enrollment
255
Locations
3
Primary Endpoint
Coagulation factor VIII
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Epidemiological studies have shown a 2-3 fold increased long-term risk of arterial cardiovascular disease after venous thrombosis, most predominant in the first year following initial venous thrombosis. The results of recent observational studies that showed 40-50% risk reductions for first venous thrombosis occurrence when using a statin are in this aspect promising. The results are also somewhat surprising, because the mechanism behind this effect is unclear. Dyslipidemia may be the most plausible explanation to be considered. However, as dyslipidemia is not related to an increased risk of venous thrombosis, it is unlikely that statins decrease venous thrombosis risk by lipid lowering activities. Recent observations indicate that coagulation can activate the initial formation of atherosclerosis. Our hypothesis is therefore that the coagulation profile in persons with venous thrombosis is improved when using a statin, ultimately leading to less atherosclerosis: another well known property of statin use.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Leiden University Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Willem M. Lijfering

Principal Investigator

Leiden University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Provision of informed consent prior to any study specific procedures
  • Persons with (initial or recurrent) confirmed symptomatic proximal deep vein thrombosis or pulmonary embolism who after a time period of at least 3 to 12 months are allowed to stop, - or stopped using \< 1 month anticoagulant treatment as indicated by their treating physician
  • Persons aged 18 years or above

Exclusion Criteria

  • Persons already using statins or lipid lowering drugs, or any other disallowed concomitant medications (erythromycin, HIV protease inhibitors, or cyclosporine)
  • History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
  • Life expectancy less than 6 months
  • Pregnant woman or woman with childbearing potential who are not willing to use contraception
  • Active liver or kidney disease or dysfunction or muscle disorders
  • Unstable medical or psychological condition that interferes with study participation

Arms & Interventions

Rosuvastatin

Intervention: Rosuvastatin

Outcomes

Primary Outcomes

Coagulation factor VIII

Time Frame: 28 days

Change in factor VIII level from baseline to 28 days of intervention

Study Sites (3)

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