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

NCT01613794 | Completed DMC

• 2 other identifiers: 2011T0122012-000223-41
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 3

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.

Conditions

Deep Vein Thrombosis; Pulmonary Embolism

Keywords

Deep vein thrombosis; Pulmonary embolism; Rosuvastatin treatment; Pharmacologic actions

Outcome Measures

Primary Outcomes (1)

• Coagulation factor VIII

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

  28 days

Study Arms (2)

No intervention

NO INTERVENTION

Rosuvastatin

EXPERIMENTAL

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

20 mg od

Also known as: crestor

Rosuvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Netherlands Heart Foundation: collaborator

Study Sites (3)

Trombosedienst Medial

Hoofddorp, South Holland, 2134TM, Netherlands

Location

Leiden anticoagulation clinic

Leiden, South Holland, 2300RC, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 22198853 BACKGROUND

• 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.

  PMID: 34953155 DERIVED

• 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.

  PMID: 27094802 DERIVED

• 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.

  PMID: 23629822 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 7, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 16, 2017

Record last verified: 2017-01

Locations

NL (3)