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

Pulmonary Embolism Clinical Trial

— Du Lac  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01164540
• Other study ID #: D3560L00093
• Status: Withdrawn
• Phase: Phase 3
• First received: July 8, 2010
• Last updated: December 9, 2010
• Start date: February 2011
• Est. completion date: March 2013

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics CommitteeItaly: Ethics CommitteeNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research EthicsSweden: Medical Products AgencySweden: Regional Ethical Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 3000
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rosuvastatin (AZD4522)
Oral dose (od) 20 mg
• Placebo
Oral dose (od)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	All cause mortality		Time to occurrence in the overall treatment period, with a median treatment period of 9,5 months	Yes
Secondary	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 to first occurrence in the overall treatment period and during the "on Vitamin K Antagonist (VKA)" treatment period	Yes