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

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ClinicalTrials.gov Identifier: NCT00408382
Recruitment Status : Completed
First Posted : December 6, 2006
Last Update Posted : November 17, 2011
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment


Arms and Interventions


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

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408382


Locations
Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Inc
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00408382     History of Changes
Other Study ID Numbers: A5481/HOP1
First Posted: December 6, 2006    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: December 2006

Keywords provided by Astellas Pharma Inc:
Lipitor
atorvastatin
Hypercholesteremia
yellow coronary plaque

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypercholesterolemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors