Patients who have undergone successful percutaneous coronary intervention
Conditions
Interventions
Pitavastatin 4mg/day
Sponsors
Hokkaido social insurance hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have undergone elective percutaneous coronary intervention and need cholesterol-lowering therapy. And also patients satisfying all of the inclusion criteria below. (1)Patients with culprit lesions in one or two coronary arteries for whom percutaneous coronary intervention is indicated. (2)Patients with lesions satisfying the registration criteria shown below. Two or fewer lesions can be registered in each vessel. 1.Non-restenotic lesion with less than 75% stenosis by visual estimation in main vessel. 2.Vessels which are visually estimated to be 3.0 mm or more in diameter at the evaluation site. 3.Vessels which curve at less than 60 degrees and in which IVUS and OCT can be inserted. 4.Vessels showing moderate or less calcification into which IVUS and OCT can be inserted. (3)Patients in whom successful PCI is accomplished in all the culprit lesions without the complications listed below. 1.Chest pain and/or ST segment elevation persisting for more than 10 minutes during the operation. 2.Slow flow or no reflow 3.Side branch occlusion 4.Coronary artery perforation 5.Distal embolism which prevented TIMI flow grade 3 6.Coronary dissection more severe than type C 7.Cardiopulmonary resuscitation 8.Ventricular tachyarrhythmia necessitating continuous drug treatment 9.Acute cardiac insufficiency 10.Intratracheal intubation 11.Use of IABP (4)Patients with hypercholesterolemia as defined by the criteria below. 1.TC>220mg/dL 2.LDL-C>140mg/dL 3.Patients in whom cholesterol-lowering treatment is judged to be necessary by the investigator (5)Patients 20 years or older at the time of provision of consent (6)Patients giving written consent on their own volition after being provided sufficient explanation about the method and purpose of the trial.
Exclusion criteria
Exclusion criteria: (1)Patients already receiving HMG-CoA reductase inhibitors (statin). (2)Patients who have received statins less than one year before. (3)Patients in whom the culprit lesion is in the left main trunk (4)Patients having triple-vessel disease and need PCI for all the three main branches. (5)Patients who had previous PCI on the lesion under evaluation. (6)Patients who have plaque in a non-culprit site on the PCI vessel and might require PCI for it during the treatment period. (7)Patients with cardiogenic shock (8)Patients with refractory ventricular tachyarrhythmia or fibrillation necessitating intravenous drug treatment or a defibrillator. (9)Patients with acute impulse-conducting disorder necessitating temporary insertion of a pacemaker. (10)Patients receiving cyclosporine. (11)Patients with allergy to pitavastatin or any other component of LIVALO. (12)Patients who are judged to be ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in characteristics and volume of coronary plaques using Virtual- Histology intravascular ultrasound(VH-IVUS), optical coherence tomography(OCT) and multidetector-row CT(MDCT). | — |
Countries
Japan
Contacts
Public ContactTeppei Sugaya
Hokkaido Social Insurance Hospital Cardiovascular center
Outcome results
None listed