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

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00408382
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Patients Per Site: 25

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hypercholesteremia; Coronary Artery Disease	Drug: atorvastatin, Lipitor	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment

Outcome Measures

Primary Outcome Measures

1. Changes in plaque characteristics as observed by coronary angioscopy []

2. (the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee) []

3. Changes in the volume and the echogenicity as observed by intravascular ultrasound []

Secondary Outcome Measures

1. Rate of change in serum lipid level []

2. Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Osaka		Japan
2		Tokyo		Japan

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Director: Use Central Contact, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00408382
• Other Study ID Numbers: A5481/HOP1
• First Posted: Dec 6, 2006
• Last Update Posted: Nov 17, 2011
• Last Verified: Dec 1, 2006

• Keywords provided by , ,: Lipitor; atorvastatin; Hypercholesteremia; yellow coronary plaque
• Additional relevant MeSH terms: Coronary Artery Disease; Hypercholesterolemia; Atorvastatin

Study Results

No Results Posted as of Nov 17, 2011