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

AstraZeneca3,000 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

3,000

Conditions

Venous Thrombosis Pulmonary Embolism

Interventions

Rosuvastatin (AZD4522)DRUG

Oral dose (od) 20 mg

PlaceboDRUG

Oral dose (od)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

All cause mortality

Time frame: 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 frame: Time to first occurrence in the overall treatment period and during the "on Vitamin K Antagonist (VKA)" treatment period

Data from ClinicalTrials.gov

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