Clinical trial NCT01058057: Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2
Official title: Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Coronary Angioplasty
Keywords: atorvastatin
percutaneous coronary intervention
periprocedural myocardial infarction
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: periprocedural myocardial infarction measured by troponin I level
timeFrame: 24 hours after PCI
Secondary outcomes:
measure: periprocedural myocardial infarction measured by creatinine kinase myocardial band
timeFrame: 24 hours after PCI
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Dpt. of Cardiology, University Hospital Motol
Study officials:
affiliation: Department of Cardiology, University Hospital Motol
name: David Zemanek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Carldiology, University Hospital Motol
name: Josef Veselka, Prof., MD., PhD.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.