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

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary angioplasty, Myocardial infarction Read More

Inclusion Criteria:

• Patients with clinical signs of stable angina (Classification of Canadian Cardiovascular Society 1, 2, 3 or 4) or asymptomatic with evidence of ischemia-induced functional tests with indication of elective PCI.
• Use of statins for a period equal to or greater than 7 days or reported by the patient and confirmed by medical prescription.
• Stent implantation in de novo lesions in native coronary arteries were considered eligible for the study
• The patient or legal representative must sign the consent form before the procedure, in form containing all the details of the research approved by the Ethics Committee of the Institution.

Exclusion Criteria:

• Women of childbearing potential who are not using appropriate contraceptive measures during pregnancy and lactation .
• Values above the upper limit of normal serum levels of CK-MB mass harvested 24 hours prior to the procedure.
• Myocardial infarction < 15 days.
• Renal insufficiency with creatinine clearance < 30 ml/min
• Patients with known allergy, hypersensitivity or contraindication to any of the following: aspirin , heparin , clopidogrel , ticagrelor , and statin or iodinated contrast .
• Participation in other research to influence serum levels of CK-MB mass
• Have taken fibrate 24 hours before the intervention .
• Use of oral anticoagulants or glycoprotein inhibitors at the day of the procedure .
• Evidence of angiographic intracoronary thrombus in the target lesion .
• In -stent restenosis , vein graft or arterial .
• Complications of the procedure as irreversible occlusion of the target vessel as well as branch greater than 1mm in diameter , presence of dissection with compromised flow, caging branch with reduced flow , coronary spasm with abnormal blood flow and distal embolization .
• Inability to deploy stent .
• Use of atherectomy technique .
• Patients were randomized to rosuvastatin be administered prior to the procedure , having the guidewire stent reached the ostium of the coronary target with time less than two hours or having exceeded the period of six hours after oral ingestion.