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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014