Atorvastatin in Perioperative Vascular Surgery - Pilot Study (APVS)

February 13, 2009 updated by: University of Campinas, Brazil

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083970
        • Clinics Hospital - State University Campinas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Atorvastatin
Atorvastatin 20 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 80 mg; Use Atorvastatin 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality ; myocardial infarction ; stroke
Time Frame: within 90 days after surgery
within 90 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

February 7, 2008

First Posted (Estimate)

February 8, 2008

Study Record Updates

Last Update Posted (Estimate)

February 16, 2009

Last Update Submitted That Met QC Criteria

February 13, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCM-UNICAMP - 620/2006
  • 0492.0.146.000-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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