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

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis; Pulmonary Embolism
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT01613794
• Lead Sponsor: Leiden University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-07
• Study Start: 2012-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Coagulation factor VIII	28 days	Change in factor VIII level from baseline to 28 days of intervention

Trial Locations

Locations (3)

Trombosedienst Medial; 🇳🇱 Hoofddorp, Zuid Holland, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Leiden anticoagulation clinic; 🇳🇱 Leiden, Zuid Holland, Netherlands