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

Leiden University Medical Center (LUMC)

Status

Completed

Conditions

Pulmonary Embolism

Deep Vein Thrombosis

Treatments

Drug: Rosuvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01613794

2012-000223-41 (EudraCT Number)

2011T012

Details and patient eligibility

About

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.

Enrollment

255 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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