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

Phase 3

Withdrawn

• Conditions: Venous Thrombosis; Pulmonary Embolism
• Interventions: Drug: Rosuvastatin (AZD4522); Drug: Placebo

• Registration Number: NCT01164540
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-08
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-10
• Study Start: 2011-02
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin (AZD4522)	Oral Treatment
2	Placebo	Oral treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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