Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Atorvastatin

• Registration Number: NCT00469326
• Lead Sponsor: University Hospital, Motol

Brief Summary

This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.

Detailed Description

Randomized studies have shown that pre-treatment with atorvastatin may reduced periprocedural myocardial in patient with stable angina during elective PCI. These data provide evidence-based support for using atorvastatin 7 days before PCI (dosage 40mg/d), alternatively three or more days (unknown dosage). We want to confirm this results for shorter pre-treatment period (two days) with dosage 80mg per day.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-26
• Last Update Posted: 2009-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• stable angina in last month
• indication for percutaneous coronary intervention
• informed consent

Exclusion Criteria

• acute coronary syndrome in last 14 days
• renal insufficiency (creatinine more 150 µmol/l)
• diseases severely limiting prognosis
• immunosuppressive treatment
• statin one month before randomization
• occlusion of the coronary artery
• previous participation in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atorvastatin	Atorvastatin	atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)
control	Atorvastatin	PCI without atorvastatin pretreatment

Primary Outcome Measures

Name	Time	Method
periprocedural myocardial infarction measured by troponin I level	24 hours

Secondary Outcome Measures

Name	Time	Method
periprocedural myocardial infarction measured by creatine kinase myocardial band	24 hours

Trial Locations

Locations (1)

Department of Cardiology, CardioVascular Center, University Hospital Motol; 🇨🇿 Prague, Czech Republic