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Study on the Effect of Rosuvastatin Treatment on the Prevention of Thrombosis in Patients With Previous Thrombosis (Du Lac)

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ClinicalTrials.gov Identifier: NCT01164540
Recruitment Status : Withdrawn (Due to discussion regarding the design of the study.)
First Posted : July 16, 2010
Last Update Posted : December 10, 2010
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Pulmonary Embolism Drug: Rosuvastatin (AZD4522) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Oral Treatment
Drug: Rosuvastatin (AZD4522)
Oral dose (od) 20 mg
Other Name: Crestor
Placebo Comparator: 2
Oral treatment
Drug: Placebo
Oral dose (od)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: Time to occurrence in the overall treatment period, with a median treatment period of 9,5 months ]
  2. 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 ]
    Time to first occurrence in the overall treatment period and during the "on (VKA)" treatment period, with an estimated average "on (VKA) treatment period" of 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164540

Sponsors and Collaborators
Principal Investigator: H. R. Büller, MD, PhD Academic Medical Centre
Study Director: Michael Cressman, MD AstraZeneca

Responsible Party: Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01164540     History of Changes
Other Study ID Numbers: D3560L00093
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Deep venous thrombosis
Pulmonary embolism
rosuvastatin treatment

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