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

AstraZeneca

Status and phase: Withdrawn; Phase 3

Conditions: Pulmonary Embolism; Venous Thrombosis

Treatments: Drug: Placebo; Drug: Rosuvastatin (AZD4522)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01164540

D3560L00093

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,000 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Oral Treatment

Treatment:

Drug: Rosuvastatin (AZD4522)

2

Placebo Comparator group

Description:

Oral treatment

Treatment:

Drug: Placebo