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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-12-31

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). 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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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atorvastatin

atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

two days 80mg atorvastatin pre-treatment before PCI

control

PCI without atorvastatin pretreatment

Group Type NO_INTERVENTION

Atorvastatin

Intervention Type DRUG

two days 80mg atorvastatin pre-treatment before PCI

Interventions

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Atorvastatin

two days 80mg atorvastatin pre-treatment before PCI

Intervention Type DRUG

Other Intervention Names

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Torvacard

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No