CClinicalTrials.gg
CompletedNCT01613794STARTUpdated Jan 16, 2017

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

An interventional study of Rosuvastatin in Deep Vein Thrombosis and Pulmonary Embolism, sponsored by Leiden University Medical Center. Completed at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-16.

Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
255
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Deep Vein Thrombosis
  • Pulmonary Embolism

Keywords

  • Deep vein thrombosis
  • Pulmonary embolism
  • Rosuvastatin treatment
  • Pharmacologic actions
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In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's enrollment of 255 is above the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
255 participants (actual)

Study arms

  • No intervention
    No intervention
  • Experimental
    Rosuvastatin

    Drug: Rosuvastatin

Interventions

  • DrugRosuvastatin

    20 mg od

    Also known as: crestor

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What researchers measure

Primary outcomes

  1. Coagulation factor VIII

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

    Time frame: 28 days

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Study locations

3 sites
  • Trombosedienst Medial
    Hoofddorp, Zuid Holland 2134TM, Netherlands
  • Leiden anticoagulation clinic
    Leiden, Zuid Holland 2300RC, Netherlands
  • Erasmus Medical Center
    Rotterdam, Netherlands
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References and documents

Publications

  • 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. PubMed 22198853 ↗
  • 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. PubMed 34953155 ↗
  • 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. PubMed 27094802 ↗
  • 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. PubMed 23629822 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01613794
Lead sponsor
Leiden University Medical Center
Collaborators
Netherlands Heart Foundation
Responsible party
Willem M. Lijfering (Principal Investigator, Leiden University Medical Center) — Principal investigator
First posted
Jun 7, 2012
Start date
Dec 2012
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 16, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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