Clinical trial NCT01613794: Rosuvastatin Use to Improve the Coagulation Profile in Patients With Venous Thrombosis
Official title: Prospective Randomized Controlled, Open Label, Clinical Trial to Study if Rosuvastatin Use Improves the Coagulation Profile in Patients With Venous Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Keywords: Deep vein thrombosis
Pulmonary embolism
Rosuvastatin treatment
Pharmacologic actions
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Heart Foundation
First posted: 2012-06-07
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Coagulation factor VIII
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hoofddorp
country: Netherlands
facility: Trombosedienst Medial
state: Zuid Holland
city: Leiden
country: Netherlands
facility: Leiden anticoagulation clinic
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
References:
citation: Lijfering WM, Flinterman LE, Vandenbroucke JP, Rosendaal FR, Cannegieter SC. Relationship between venous and arterial thrombosis: a review of the literature from a causal perspective. Semin Thromb Hemost. 2011 Nov;37(8):885-96. doi: 10.1055/s-0031-1297367. Epub 2011 Dec 23.
citation: Ramberg C, Hindberg K, Biedermann JS, Cannegieter SC, van der Meer FJ, Snir O, Leebeek FWG, Kruip MJHA, Hansen JB, Lijfering WM. Rosuvastatin treatment decreases plasma procoagulant phospholipid activity after a VTE: A randomized controlled trial. J Thromb Haemost. 2022 Apr;20(4):877-887. doi: 10.1111/jth.15626. Epub 2022 Jan 8.
citation: Biedermann JS, Cannegieter SC, Roest M, van der Meer FJ, Reitsma PH, Kruip MJ, Lijfering WM. Platelet reactivity in patients with venous thrombosis who use rosuvastatin: a randomized controlled clinical trial. J Thromb Haemost. 2016 Jul;14(7):1404-9. doi: 10.1111/jth.13343. Epub 2016 Jun 10.
citation: Lippi G, Favaloro EJ, Sanchis-Gomar F. Venous thrombosis associated with HMG-CoA reductase inhibitors. Semin Thromb Hemost. 2013 Jul;39(5):515-32. doi: 10.1055/s-0033-1343892. Epub 2013 Apr 29.