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

Pulmonary Embolism Clinical Trial

— START  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613794
• Other study ID #: 2011T012
• Secondary ID: 2012-000223-41
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: January 13, 2017
• Start date: December 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rosuvastatin
20 mg od

Locations

Country	Name	City	State
Netherlands	Trombosedienst Medial	Hoofddorp	Zuid Holland
Netherlands	Leiden anticoagulation clinic	Leiden	Zuid Holland
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Netherlands Heart Foundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coagulation factor VIII	Change in factor VIII level from baseline to 28 days of intervention	28 days