Atorvastatin in Perioperative Vascular Surgery - Pilot Study - Full Text View

Sponsor:	University of Campinas, Brazil
Information provided by:	University of Campinas, Brazil
ClinicalTrials.gov Identifier:	NCT00610545

Purpose

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

Condition	Intervention	Phase
Vascular Surgery	Drug: Atorvastatin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment
Official Title:	Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Statins Surgery

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:

mortality ; myocardial infarction ; stroke [ Time Frame: within 90 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change and percent change from baseline to the surgery of treatment for LDL-C, HDL-C, TC, and TG for subjects [ Time Frame: within 24h before surgery ] [ Designated as safety issue: Yes ]
Change and percent change from baseline to the surgery of treatment for hs-CRP [ Time Frame: within 24h before surgery ] [ Designated as safety issue: Yes ]
Safety of atorvastatin through laboratory assessment [ Time Frame: within 24h before surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	July 2007
Study Completion Date:	December 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Use Atorvastatin 80mg for 60 days , and the vascular surgery will be made between day-7 and day-60	Drug: Atorvastatin Atorvastatin 80 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60
2: Active Comparator Use Atorvastatin 20 mg for 60 days , and the vascular surgery will be made between day-7 and day-60	Drug: Atorvastatin Atorvastatin 20 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610545

Locations

Brazil, SÃO PAULO
Clinics Hospital - State University Campinas
CAMPINAS, SÃO PAULO, Brazil, 13083970

Sponsors and Collaborators

University of Campinas, Brazil

Investigators

Study Director:	OTAVIO COELHO, PhD	STATE UNIVERSITY CAMPINAS
Principal Investigator:	RAITANY C ALMEIDA, MD	STATE UNIVERSITY CAMPINAS

More Information

No publications provided

Responsible Party:	STATE UNIVERSITY OF CAMPINAS ( RAITANY COSTA DE ALMEIDA )
Study ID Numbers:	FCM-UNICAMP - 620/2006, 0492.0.146.000-06
Study First Received:	January 28, 2008
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00610545 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:

ATORVASTATIN
VASCULAR SURGERY
CARDIOVASCULAR OUTCOMES

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Atorvastatin

ClinicalTrials.gov processed this record on February 04, 2010