Clinical trial NCT00469326: Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study
Official title: Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
percutaneous coronary intervention
atorvastatin
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2007-05-04
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: periprocedural myocardial infarction measured by troponin I level
timeFrame: 24 hours
Secondary outcomes:
measure: periprocedural myocardial infarction measured by creatine kinase myocardial band
timeFrame: 24 hours
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Department of Cardiology, CardioVascular Center, University Hospital Motol
Study officials:
affiliation: Department of Cardiology, Cardiovascular Center, University Hospital Motol, Prague, Czech Republic
name: Josef Veselka, Prof., PhD.
role: STUDY_CHAIR
References:
citation: Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2004 Aug 10;110(6):674-8. doi: 10.1161/01.CIR.0000137828.06205.87. Epub 2004 Jul 26.
citation: Briguori C, Colombo A, Airoldi F, Violante A, Focaccio A, Balestrieri P, Paolo Elia P, Golia B, Lepore S, Riviezzo G, Scarpato P, Librera M, Bonizzoni E, Ricciardelli B. Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction. Eur Heart J. 2004 Oct;25(20):1822-8. doi: 10.1016/j.ehj.2004.07.017.
citation: Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tomasov P, Tesar D. Effect of two-day atorvastatin pretreatment on long-term outcome of patients with stable angina pectoris undergoing elective percutaneous coronary intervention. Am J Cardiol. 2011 May 1;107(9):1295-9. doi: 10.1016/j.amjcard.2010.12.040. Epub 2011 Feb 23.
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.