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Completed

NCT Number: NCT00610545

Atorvastatin in Perioperative Vascular Surgery - Pilot Study

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

Completed

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Key information

Conditions

Vascular Surgery

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinics Hospital - State University Campinas

Campinas, São Paulo, 13083970, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Atorvastatin 80 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60

Primary outcomes

  1. mortality ; myocardial infarction ; stroke

    Time frame: within 90 days after surgery

Secondary outcomes

  1. 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

  2. Change and percent change from baseline to the surgery of treatment for hs-CRP

    Time frame: within 24h before surgery

  3. Safety of atorvastatin through laboratory assessment

    Time frame: within 24h before surgery

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes

Acronym: APVS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 8, 2008
Registry last updated
Feb 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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