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Randomized Trial of Creatine-kinase Leak After Rosuvastatin At the Time of Percutaneous Coronary Intervention — CLEAR-PCI  

Coronary Artery Disease Clinical Trial

Official title:
Randomized Trial of Creatine-kinase Leak After Rosuvastatin At the Time of Percutaneous Coronary Intervention

Clinical Trial Summary

Patients with stable coronary disease when undergoing percutaneous coronary intervention may present periprocedural myocardial infarction defined at present as a creatine kinase-myocardial isoenzyme (CK-MB) elevation 3 times upper limit of normal, as a cut off for periprocedural myocardial infarction after PCI. Although percutaneous coronary intervention is associated with low rates of complications, periprocedural myocardial infarction has been touted as a negative factor in long-term clinical results . Several clinical, anatomical and technical associate to the occurrence of this event . Although randomized controlled trials and systematic reviews to statin pre intervention have targeted the administration of high-dose statin is recommended before surgery to reduce the risk of periprocedural myocardial infarction, there is no information on the impact of the maximum concentration plasma of statin at the time of percutaneous coronary intervention in stable patients on chronic statin use in preventing periprocedural myocardial infarction or the elevation of cardiac enzymes . The anti-ischemic effect of statins in percutaneous coronary intervention was mainly determined in statin -naïve patients or in patients with acute coronary syndromes . In this work , we studied the impact of the peak plasma concentration of statin at the time of percutaneous coronary intervention was studied through prospective randomized single center in stable patients with chronic statin divided into two groups . In the group (1) Experimental (n = 268 ) was administered at a dose of 40 mg rosuvastatin between one and six hours before surgery and group (2) control without rosuvastatin (n = 268). This range 1 to 6 hours is the time at the peak concentration of rosuvastatin in the blood after oral ingestion. The primary objective was to assess the incidence of periprocedural myocardial infarction by creatine kinase above three times upper normal limit in hospital period and as a secondary objective to analyze the elevation of any amount of creatine kinase on the baseline.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01968577
Study type Interventional
Source University of Sao Paulo
Contact Keber B A Martins, MD
Phone 55 79 8102-9611
Email klebermartins@usp.br
Status Unknown status
Phase Phase 4
Start date March 2011
Completion date December 2013
View Details
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