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Atorvastatin in Perioperative Vascular Surgery - Pilot Study (APVS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610545
First Posted: February 8, 2008
Last Update Posted: February 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Campinas, Brazil
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • mortality ; myocardial infarction ; stroke [ Time Frame: within 90 days after surgery ]

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 ]
  • Change and percent change from baseline to the surgery of treatment for hs-CRP [ Time Frame: within 24h before surgery ]
  • Safety of atorvastatin through laboratory assessment [ Time Frame: within 24h before surgery ]

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
Active Comparator: 1
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
Active Comparator: 2
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610545


Locations
Brazil
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

Responsible Party: RAITANY COSTA DE ALMEIDA, STATE UNIVERSITY OF CAMPINAS
ClinicalTrials.gov Identifier: NCT00610545     History of Changes
Other Study ID Numbers: FCM-UNICAMP - 620/2006
0492.0.146.000-06
First Submitted: January 28, 2008
First Posted: February 8, 2008
Last Update Posted: February 16, 2009
Last Verified: February 2009

Keywords provided by University of Campinas, Brazil:
ATORVASTATIN
VASCULAR SURGERY
CARDIOVASCULAR OUTCOMES

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors