Atorvastatin in Perioperative Vascular Surgery - Pilot Study

NCT00610545 | Completed Phase 4 DMC

• 2 other identifiers: FCM-UNICAMP - 620/20060492.0.146.000-06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vascular Surgery

Keywords

ATORVASTATIN; VASCULAR SURGERY; CARDIOVASCULAR OUTCOMES

Outcome Measures

Primary Outcomes (1)

• mortality ; myocardial infarction ; stroke

  within 90 days after surgery

Secondary Outcomes (3)

• Change and percent change from baseline to the surgery of treatment for LDL-C, HDL-C, TC, and TG for subjects

  within 24h before surgery

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

  within 24h before surgery

• Safety of atorvastatin through laboratory assessment

  within 24h before surgery

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Atorvastatin

2

ACTIVE COMPARATOR

Use Atorvastatin 20 mg for 60 days , and the vascular surgery will be made between day-7 and day-60

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

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

1

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vascular surgery (abdominal aortic aneurysm , carotid endarterectomy , limbs revascularization)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Clinics Hospital - State University Campinas

Campinas, São Paulo, 13083970, Brazil

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• OTAVIO COELHO, PhD

  STATE UNIVERSITY CAMPINAS

  STUDY DIRECTOR

• RAITANY C ALMEIDA, MD

  STATE UNIVERSITY CAMPINAS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 8, 2008
• Study Start: July 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 16, 2009

Record last verified: 2009-02

Locations

BR (1)