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

This study is currently recruiting participants.
Verified December 2012 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: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Deep Vein Thrombosis
Pulmonary Embolism
 Drug: Rosuvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Prospective Randomized Controlled, Open Label, Clinical Trial to Study if Rosuvastatin Use Improves the Coagulation Profile in Patients With Venous Thrombosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Coagulation factor VIII [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Change in factor VIII level from baseline to 28 days of intervention


Estimated Enrollment: 250
Study Start Date: December 2012
Arms Assigned Interventions
No Intervention: No intervention
Experimental: Rosuvastatin Drug: Rosuvastatin
20 mg od
Other Name: crestor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613794

Contacts
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

Locations
Netherlands
Leiden anticoagulation clinic Recruiting
Leiden, Zuid Holland, Netherlands, 2300RC
Contact: Willem M Lijfering, MD PhD     +31 71 526 1384     w.m.lijfering@lumc.nl    
Principal Investigator: Willem m Lijfering, MD PhD            
Sponsors and Collaborators
Leiden University Medical Center
Netherlands Heart Foundation
  More Information

Publications:

Responsible Party: Willem M. Lijfering, Principal Investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01613794     History of Changes
Other Study ID Numbers: 2011T012, 2012-000223-41
Study First Received: May 31, 2012
Last Updated: December 12, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
Deep vein thrombosis
Pulmonary embolism
Rosuvastatin treatment
Pharmacologic actions

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
 Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013