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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 28, 2008 | ||||||||
| Last Updated Date | February 13, 2009 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
mortality ; myocardial infarction ; stroke [ Time Frame: within 90 days after surgery ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00610545 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Atorvastatin in Perioperative Vascular Surgery - Pilot Study | ||||||||
| Official Title ICMJE | Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes | ||||||||
| Brief Summary | This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in comparative standard doses in the perioperative period of major vascular surgery. Abdominal aortic aneurysm , Carotid endarterectomy , Revascularization of lower limbs |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment | ||||||||
| Condition ICMJE | Vascular Surgery | ||||||||
| Intervention ICMJE | Drug: Atorvastatin | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Completion Date | December 2008 | ||||||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00610545 | ||||||||
| Responsible Party | RAITANY COSTA DE ALMEIDA, STATE UNIVERSITY OF CAMPINAS | ||||||||
| Study ID Numbers ICMJE | FCM-UNICAMP - 620/2006, 0492.0.146.000-06 | ||||||||
| Study Sponsor ICMJE | University of Campinas, Brazil | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of Campinas, Brazil | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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