Rosuvastatin Use to Improve 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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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trombosedienst Medial, Hoofddorp, South Holland, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

20 mg od

Other names: crestor

Primary outcomes

Coagulation factor VIII

Time frame: 28 days

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

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

Netherlands Heart Foundation

Registry information

Official study title

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

Acronym: START

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Jun 7, 2012
Registry last updated: Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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