Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408382
• Other study ID #: A5481/HOP1
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2006
• Last updated: November 15, 2011

Study information

• Verified date: December 2006
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

• Patients with hypercholesteremia

• The indication of coronary angiography, coronary angioscopy and intravascular ultrasound are expected

Exclusion Criteria:

• Patients who has current administration of Lipitor or history of discontinued administration of Lipitor

• Acute cardiac infarction

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hypercholesteremia
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

Drug:
• atorvastatin, Lipitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Hirayama A, Saito S, Ueda Y, Takayama T, Honye J, Komatsu S, Yamaguchi O, Li Y, Yajima J, Nanto S, Takazawa K, Kodama K. Qualitative and quantitative changes in coronary plaque associated with atorvastatin therapy. Circ J. 2009 Apr;73(4):718-25. Epub 2009 Feb 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plaque characteristics as observed by coronary angioscopy
Primary	(the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee)
Primary	Changes in the volume and the echogenicity as observed by intravascular ultrasound
Secondary	Rate of change in serum lipid level
Secondary	Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee)