Rosuvastatin Use to Improve the Coagulation Profile in Patients With Venous Thrombosis (START)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Leiden University Medical Center
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by (Responsible Party):
Willem M. Lijfering, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01613794
First received: May 31, 2012
Last updated: January 6, 2014
Last verified: January 2014

May 31, 2012
January 6, 2014
December 2012
Not Provided
Coagulation factor VIII [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Change in factor VIII level from baseline to 28 days of intervention
Same as current
Complete list of historical versions of study NCT01613794 on ClinicalTrials.gov Archive Site
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Rosuvastatin Use to Improve the Coagulation Profile in Patients With Venous Thrombosis
Prospective Randomized Controlled, Open Label, Clinical Trial to Study if Rosuvastatin Use Improves the Coagulation Profile in Patients With Venous Thrombosis

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Deep Vein Thrombosis
  • Pulmonary Embolism
Drug: Rosuvastatin
20 mg od
Other Name: crestor
  • No Intervention: No intervention
  • Experimental: Rosuvastatin
    Intervention: Drug: Rosuvastatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
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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
Both
18 Years and older
No
Contact: Willem M Lijfering, MD PhD +31 71 526 1384 w.m.lijfering@lumc.nl
Contact: Suzanne C Cannegieter, MD PhD +31 71 526 5634 s.c.cannegieter@lumc.nl
Netherlands
 
NCT01613794
2011T012, 2012-000223-41
Yes
Willem M. Lijfering, Leiden University Medical Center
Leiden University Medical Center
Netherlands Heart Foundation
Not Provided
Leiden University Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP