Back to resultsStudy on the Effect of Rosuvastatin Treatment on the Prevention of Thrombosis in Patients With Previous Thrombosis (Du Lac)
Primary Purpose
Venous Thrombosis, Pulmonary Embolism
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin (AZD4522)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Venous Thrombosis focused on measuring Deep venous thrombosis, Pulmonary embolism, rosuvastatin treatment
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Oral Treatment
Oral treatment
Outcomes
Primary Outcome Measures
Any event of venous thromboembolism (i.e. Deep Vein Thrombosis (DVT) and/or fatal or non-fatal Pulmonary Embolism(PE))
Secondary Outcome Measures
All cause mortality
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01164540
Brief Title
Study on the Effect of Rosuvastatin Treatment on the Prevention of Thrombosis in Patients With Previous Thrombosis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Due to discussion regarding the design of the study.
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis, Pulmonary Embolism
Keywords
Deep venous thrombosis, Pulmonary embolism, rosuvastatin treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Oral Treatment
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Oral treatment
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin (AZD4522)
Other Intervention Name(s)
Crestor
Intervention Description
Oral dose (od) 20 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral dose (od)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
Time to occurrence in the overall treatment period, with a median treatment period of 9,5 months
Title
Any event of the composite of venous thromboembolism or arterial thromboembolism/major adverse cardiovascular event (MACE)
Description
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 Frame
Time to first occurrence in the overall treatment period and during the "on Vitamin K Antagonist (VKA)" treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. R. Büller, MD, PhD
Organizational Affiliation
Academic Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Cressman, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study on the Effect of Rosuvastatin Treatment on the Prevention of Thrombosis in Patients With Previous Thrombosis
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