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

NCT ID: NCT01058057

Last Updated: 2010-02-03

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

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:

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)

Conditions

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Coronary Artery Disease Coronary Angioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atorvastatin

Atorvastatin 80mg seven days pre-treatment before PCI

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

atorvastatin 80mg p.o. daily seven days before PCI

Interventions

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atorvastatin

atorvastatin 80mg p.o. daily seven days before PCI

Intervention Type DRUG

Other Intervention Names

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Torvacard

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Motol

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Motol

Principal Investigators

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David Zemanek, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, University Hospital Motol

Josef Veselka, Prof., MD., PhD.

Role: STUDY_CHAIR

Department of Carldiology, University Hospital Motol

Locations

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Dpt. of Cardiology, University Hospital Motol

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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David Zemanek, MD

Role: CONTACT

+420608921

Facility Contacts

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David Zemanek, MD

Role: primary

+420608921566

References

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Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tesar D. Effect of two-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following elective percutaneous coronary intervention: a single-center, prospective, and randomized study. Am J Cardiol. 2009 Sep 1;104(5):630-3. doi: 10.1016/j.amjcard.2009.04.048. Epub 2009 Jun 24.

Reference Type BACKGROUND
PMID: 19699335 (View on PubMed)

Di Sciascio G, Patti G, Pasceri V, Gaspardone A, Colonna G, Montinaro A. Efficacy of atorvastatin reload in patients on chronic statin therapy undergoing percutaneous coronary intervention: results of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) Randomized Trial. J Am Coll Cardiol. 2009 Aug 4;54(6):558-65. doi: 10.1016/j.jacc.2009.05.028. Epub 2009 Jul 2.

Reference Type BACKGROUND
PMID: 19643320 (View on PubMed)

Mood GR, Bavry AA, Roukoz H, Bhatt DL. Meta-analysis of the role of statin therapy in reducing myocardial infarction following elective percutaneous coronary intervention. Am J Cardiol. 2007 Sep 15;100(6):919-23. doi: 10.1016/j.amjcard.2007.04.022. Epub 2007 Jun 26.

Reference Type BACKGROUND
PMID: 17826370 (View on PubMed)

Other Identifiers

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KC EK-150/08

Identifier Type: -

Identifier Source: org_study_id

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