Virtual Histology Findings and Effects of Varying Doses of Atorvastatin Treatment

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

While statin treatment may induce plaque regression, the effect of statin on plaque composition with varying doses is unknown. This study assessed such effects by volumetric virtual histology intravascular ultrasound (VH-IVUS).

In this prospective, randomized, double-blinded pilot study, statin-naïve patients with stable angina requiring percutaneous coronary intervention (PCI) were randomized to receive 6 months of either atorvastatin 10mg or 40 mg daily. VH-IVUS was performed in all non-PCI lesions at baseline and 6 months; all analyses were performed by core laboratory.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Stephen Lee
• Collaborators: Pfizer; Queen Mary Hospital, Hong Kong
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Patient aged 18 to 85 (not pregnant) requiring percutaneous intervention to coronary stenosis.

• Statin naive patient.

• No history of myocardial infarction. Angina free for at least 8 weeks.

Exclusion Criteria:

• Any history of previous statin treatment and myocardial infarction

• Current acute coronary syndrome or in cardiogenic shock

• Surgical bypass candidate

• Chronic total occlusion and very tortuous calcified arteries precluding safe IVUS examination.

• Patient refused to give written informed consent.