Plaque-Stabilizing Action of Pitavastatin in Coronary Artery Disease

UMIN ID: UMIN000001520

Registered date:25/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients who have undergone successful percutaneous coronary intervention
• Date of first enrollment: 2008/11/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Pitavastatin 4mg/day

Outcome(s)

• Primary Outcome: Changes in characteristics and volume of coronary plaques using Virtual- Histology intravascular ultrasound(VH-IVUS), optical coherence tomography(OCT) and multidetector-row CT(MDCT).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Hokkaido social insurance hospital
• Source(s) of Monetary Support: None