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Atorvastatin in Perioperative Vascular Surgery - Pilot Study (APVS)

This study has been completed.
Sponsor:
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT00610545
First received: January 28, 2008
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes

Resource links provided by NLM:

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
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

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
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: 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
Study First Received: January 28, 2008
Last Updated: February 13, 2009
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:
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013