Atorvastatin in Perioperative Vascular Surgery - Pilot Study
Information source: University of Campinas, Brazil
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vascular Surgery
Intervention: Atorvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Campinas, Brazil Official(s) and/or principal investigator(s): OTAVIO COELHO, PhD, Study Director, Affiliation: STATE UNIVERSITY CAMPINAS RAITANY C ALMEIDA, MD, Principal Investigator, Affiliation: STATE UNIVERSITY CAMPINAS
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
Clinical Details
Official title: Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: mortality ; myocardial infarction ; stroke
Secondary outcome: Change and percent change from baseline to the surgery of treatment for LDL-C, HDL-C, TC, and TG for subjectsChange and percent change from baseline to the surgery of treatment for hs-CRP Safety of atorvastatin through laboratory assessment
Eligibility
Minimum age: 40 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Vascular surgery (abdominal aortic aneurysm , carotid endarterectomy , limbs
revascularization)
Exclusion Criteria:
- Pregnant or lactating women
- Patient with sensitivity to atorvastatin
- Patient has elevations in certain laboratory values (CK, AST, ALT)
- Known history of active hepatic disease or known hepatic insufficiency
- Patients participating in another clinical trial
- Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other
HMG-CoA Reductase Inhibitors (statins) or use rosuvastatin
- Serious infectious disease after surgery
- Known history of cancer
Locations and Contacts
Clinics Hospital - State University Campinas, Campinas, São Paulo 13083970, Brazil
Additional Information
Starting date: July 2007
Last updated: February 13, 2009
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