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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 subjects

Change 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

Page last updated: August 23, 2015

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