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

Study Overview
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Brief Summary
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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
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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: atorvastatin pre-treatment group (80mg atorvastatin for seven days) 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)

Official Title
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Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2

Conditions
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Coronary Artery Disease, Coronary Angioplasty

Intervention / Treatment
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* Drug: atorvastatin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>Atorvastatin 80mg seven days pre-treatment before PCI | Drug: atorvastatin<br>* atorvastatin 80mg p.o. daily seven days before PCI<br>* Other names: Torvacard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periprocedural myocardial infarction measured by troponin I level |  | 24 hours after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periprocedural myocardial infarction measured by creatinine kinase myocardial band |  | 24 hours after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atorvastatin, percutaneous coronary intervention, periprocedural myocardial infarction, Hydroxymethylglutaryl-CoA Reductase Inhibitors