Deep Vein Thrombosis, Pulmonary Embolism
Conditions
Keywords
Deep vein thrombosis, Pulmonary embolism, Rosuvastatin treatment, Pharmacologic actions
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.
Interventions
DRUGRosuvastatin
20 mg od
Sponsors
Netherlands Heart Foundation
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coagulation factor VIII | 28 days | Change in factor VIII level from baseline to 28 days of intervention |
Countries
Netherlands
Outcome results
None listed