Full Text View
Tabular View
No Study Results Posted
Related Studies
Atorvastatin in Perioperative Vascular Surgery - Pilot Study (APVS)
This study has been completed.
Study NCT00610545   Information provided by University of Campinas, Brazil
First Received: January 28, 2008   Last Updated: February 13, 2009   History of Changes

January 28, 2008
February 13, 2009
July 2007
September 2008   (final data collection date for primary outcome measure)
mortality ; myocardial infarction ; stroke [ Time Frame: within 90 days after surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00610545 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Atorvastatin in Perioperative Vascular Surgery - Pilot Study
Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes

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

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment
Vascular Surgery
Drug: Atorvastatin
  • Active Comparator: Use Atorvastatin 80mg for 60 days , and the vascular surgery will be made between day-7 and day-60
  • Active Comparator: Use Atorvastatin 20 mg for 60 days , and the vascular surgery will be made between day-7 and day-60
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
100
December 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00610545
RAITANY COSTA DE ALMEIDA, STATE UNIVERSITY OF CAMPINAS
FCM-UNICAMP - 620/2006, 0492.0.146.000-06
University of Campinas, Brazil
 
Study Director: OTAVIO COELHO, PhD STATE UNIVERSITY CAMPINAS
Principal Investigator: RAITANY C ALMEIDA, MD STATE UNIVERSITY CAMPINAS
University of Campinas, Brazil
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP