Randomized Trial of Creatine-kinase Leak After Rosuvastatin At the Time of Percutaneous Coronary Intervention
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
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.