Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2
NCT ID: NCT01058057
Last Updated: 2010-02-03
Study Results
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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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2008-02-29
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atorvastatin
Atorvastatin 80mg seven days pre-treatment before PCI
atorvastatin
atorvastatin 80mg p.o. daily seven days before PCI
Interventions
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atorvastatin
atorvastatin 80mg p.o. daily seven days before PCI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent
* Chronic statin therapy
Exclusion Criteria
* 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
ALL
No
Sponsors
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University Hospital, Motol
OTHER
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
Other Identifiers
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KC EK-150/08
Identifier Type: -
Identifier Source: org_study_id
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