Study on the Effect of Rosuvastatin Treatment on the Prevention of Thrombosis in Patients With Previous Thrombosis

Brief Summary

Official Title: “A Randomised, Double-blind, Placebo-controlled, Event Driven, Phase III Study of Rosuvastatin 20 mg Once Daily in the Long Term Prevention of Recurrent Venous Thromboembolism in Patients With Deep Vein Thrombosis or Pulmonary Embolism”

This study evaluates whether treatment with rosuvastatin on top of standard anti-coagulant treatment will decrease the risk of recurrent venous thromboembolism and arterial thromboembolic events in patients with previous deep vein thrombosis or pulmonary embolism.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2013

Interventions Used in this Clinical Trial

  • Drug: Rosuvastatin (AZD4522)
    • Oral dose (od) 20 mg
  • Drug: Placebo
    • Oral dose (od)

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Oral Treatment
  • Placebo Comparator: 2
    • Oral treatment

Outcome Measures for this Clinical Trial

Primary Measures

  • Any event of venous thromboembolism (i.e. Deep Vein Thrombosis (DVT) and/or fatal or non-fatal Pulmonary Embolism(PE))
    • Time Frame: Time to first occurrence in the overall treatment period, with a median treatment period of 9,5 months
      Safety Issue?: Yes

Secondary Measures

  • All cause mortality
    • Time Frame: Time to occurrence in the overall treatment period, with a median treatment period of 9,5 months
      Safety Issue?: Yes
  • Any event of the composite of venous thromboembolism or arterial thromboembolism/major adverse cardiovascular event (MACE)
    • Time Frame: Time to first occurrence in the overall treatment period and during the “on Vitamin K Antagonist (VKA)” treatment period
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Signed informed Consent.
  • Patients with venous thromboembolism who are treated with anti-coagulant according to the current guidelines

Exclusion Criteria

  • Patients in need of or already treated with lipid lowering drugs
  • Active liver or kidney disease or dysfunction or muscle disorders
  • Unstable medical or psychological condition that interferes with study participation
  • Pregnant woman or woman with childbearing potential who are not willing to use contraception
  • History of statin-related muscular pain, or hypersensitivity to statins

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Marketing Company Medical Director, AstraZeneca
  • Overall Official(s)
    • H. R. B├╝ller, MD, PhD, Principal Investigator, Academic Medical Centre
    • Michael Cressman, MD, Study Director, AstraZeneca


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