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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01613794
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by (Responsible Party):
Willem M. Lijfering, Leiden University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Pulmonary Embolism Drug: Rosuvastatin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: No intervention
Experimental: Rosuvastatin Drug: Rosuvastatin
20 mg od
Other Name: crestor


Outcome Measures
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Primary Outcome Measures :
  1. Coagulation factor VIII [ Time Frame: 28 days ]
    Change in factor VIII level from baseline to 28 days of intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613794


Locations
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Netherlands
Trombosedienst Medial
Hoofddorp, Zuid Holland, Netherlands, 2134TM
Leiden anticoagulation clinic
Leiden, Zuid Holland, Netherlands, 2300RC
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Leiden University Medical Center
Netherlands Heart Foundation
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Willem M. Lijfering, Principal Investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01613794    
Other Study ID Numbers: 2011T012
2012-000223-41 ( EudraCT Number )
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Willem M. Lijfering, Leiden University Medical Center:
Deep vein thrombosis
Pulmonary embolism
Rosuvastatin treatment
Pharmacologic actions
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
 Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors