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

NCT ID: NCT01164540

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-03-31

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.

Detailed Description

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Conditions

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Venous Thrombosis Pulmonary Embolism

Keywords

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Deep venous thrombosis Pulmonary embolism rosuvastatin treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Oral Treatment

Group Type EXPERIMENTAL

Rosuvastatin (AZD4522)

Intervention Type DRUG

Oral dose (od) 20 mg

2

Oral treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral dose (od)

Interventions

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Rosuvastatin (AZD4522)

Oral dose (od) 20 mg

Intervention Type DRUG

Placebo

Oral dose (od)

Intervention Type DRUG

Other Intervention Names

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Crestor

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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H. R. Büller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academic Medical Centre

Michael Cressman, MD

Role: STUDY_DIRECTOR

AstraZeneca

Other Identifiers

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D3560L00093

Identifier Type: -

Identifier Source: org_study_id