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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01164540

Acronym

Du Lac

Enrollment

3000

Registered

2010-07-16

Start date

2011-02-28

Completion date

2013-03-31

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism, Venous Thrombosis

Keywords

Deep venous thrombosis, Pulmonary embolism, rosuvastatin treatment

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.

Interventions

DRUGRosuvastatin (AZD4522)

Oral dose (od) 20 mg

DRUGPlacebo

Oral dose (od)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026