Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Leiden University Medical Center
Netherlands Heart Foundation
Information provided by (Responsible Party):
Willem M. Lijfering, Leiden University Medical Center Identifier:
First received: May 31, 2012
Last updated: March 2, 2016
Last verified: March 2016
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.

Condition Intervention
Deep Vein Thrombosis
Pulmonary Embolism
Drug: Rosuvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Prospective Randomized Controlled, Open Label, Clinical Trial to Study if Rosuvastatin Use Improves the Coagulation Profile in Patients With Venous Thrombosis

Resource links provided by NLM:

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Coagulation factor VIII [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Change in factor VIII level from baseline to 28 days of intervention

Estimated Enrollment: 250
Study Start Date: December 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No intervention
Experimental: Rosuvastatin Drug: Rosuvastatin
20 mg od
Other Name: crestor


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01613794

Contact: Willem M Lijfering, MD PhD +31 71 526 1384
Contact: Suzanne C Cannegieter, MD PhD +31 71 526 5634

Trombosedienst Medial Recruiting
Hoofddorp, Zuid Holland, Netherlands, 2134TM
Contact: Willem Lijfering, MD PhD    +31715261384   
Principal Investigator: Willem Lijfering, MD, PhD         
Leiden anticoagulation clinic Recruiting
Leiden, Zuid Holland, Netherlands, 2300RC
Contact: Willem M Lijfering, MD PhD    +31 71 526 1384   
Principal Investigator: Willem m Lijfering, MD PhD         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Marieke Kruip, MD, PhD         
Sponsors and Collaborators
Leiden University Medical Center
Netherlands Heart Foundation
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Willem M. Lijfering, Principal Investigator, Leiden University Medical Center Identifier: NCT01613794     History of Changes
Other Study ID Numbers: 2011T012  2012-000223-41 
Study First Received: May 31, 2012
Last Updated: March 2, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Leiden University Medical Center:
Deep vein thrombosis
Pulmonary embolism
Rosuvastatin treatment
Pharmacologic actions

Additional relevant MeSH terms:
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on October 28, 2016