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

This study has been withdrawn prior to enrollment.
(Due to discussion regarding the design of the study.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01164540
First received: July 8, 2010
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Venous Thrombosis
Pulmonary Embolism
Drug: Rosuvastatin (AZD4522)
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: Time to occurrence in the overall treatment period, with a median treatment period of 9,5 months ] [ Designated as safety issue: Yes ]
  • Any event of the composite of venous thromboembolism or arterial thromboembolism/major adverse cardiovascular event (MACE) [ Time Frame: Time to first occurrence in the overall treatment period and during the "on Vitamin K Antagonist (VKA)" treatment period ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 3000
Study Start Date: February 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral Treatment
Drug: Rosuvastatin (AZD4522)
Oral dose (od) 20 mg
Other Name: Crestor
Placebo Comparator: 2
Oral treatment
Drug: Placebo
Oral dose (od)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164540

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: H. R. Büller, MD, PhD Academic Medical Centre
Study Director: Michael Cressman, MD AstraZeneca
  More Information

No publications provided

Responsible Party: Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01164540     History of Changes
Other Study ID Numbers: D3560L00093
Study First Received: July 8, 2010
Last Updated: December 9, 2010
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Italy: Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Deep venous thrombosis
Pulmonary embolism
rosuvastatin treatment

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Embolism
Pulmonary Embolism
Venous Thromboembolism
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014