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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Venous Thrombosis, Pulmonary Embolism

Intervention / Treatment
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* Drug: Rosuvastatin (AZD4522)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral Treatment | Drug: Rosuvastatin (AZD4522)<br>* Oral dose (od) 20 mg<br>* Other names: Crestor;|
| Placebo Comparator: 2<br>Oral treatment | Drug: Placebo<br>* Oral dose (od)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | Time to occurrence in the overall treatment period, with a median treatment period of 9,5 months | 
| Any event of the composite of venous thromboembolism or arterial thromboembolism/major adverse cardiovascular event (MACE) | 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 | Time to first occurrence in the overall treatment period and during the on Vitamin K Antagonist (VKA) treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep venous thrombosis, Pulmonary embolism, rosuvastatin treatment