Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2

Phase 3

• Conditions: Coronary Artery Disease; Coronary Angioplasty
• Interventions: Drug: atorvastatin

• Registration Number: NCT01058057
• 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) on chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.

Detailed Description

This randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) and chronic statin therapy.

Two arms:

1. atorvastatin pre-treatment group (80mg atorvastatin for seven days)

2. control group (without atorvastatin pre-treatment, chronic statin treatment)

Primary endpoint:

Periprocedural myocardial infarction measured by troponin I level (time frame 24 hours)

Secondary endpoint:

Periprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)

Study Timeline

• Status Verified: 2008-01
• Study Start: 2008-02
• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Last Update Submitted: 2010-02-02
• Last Update Posted: 2010-02-03
• Primary Completion: 2010-06

Recruitment & Eligibility

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

Inclusion Criteria

• Indication for percutaneous coronary intervention
• Informed consent
• Chronic statin therapy

Exclusion Criteria

• Acute coronary syndrome in last 14 days
• Renal insufficiency (creatinine more 150 umol/l)
• Diseases severely limiting prognosis
• Previous participation in this study
• Chronic occlusion of the coronary artery, bypass intervention, left main intervention
• Chronic statin treatment with atorvastatin 80mg daily and rosuvastatin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	atorvastatin	Atorvastatin 80mg seven days pre-treatment before PCI

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
periprocedural myocardial infarction measured by creatinine kinase myocardial band	24 hours after PCI

Trial Locations

Locations (1)

Dpt. of Cardiology, University Hospital Motol; 🇨🇿 Prague, Czech Republic