Text Size

Effect of Statin Treatment on Coronary Plaque Stabilization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Wakayama Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00700037
First received: June 13, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary syndrome.


Condition Intervention Phase
Acute Coronary Syndrome
Atherosclerosis
Dyslipidemia
 Drug: high-dose atorvastatin
Drug: low-dose atorvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Aggressive Lipid-Lowering Therapy With a High-Dose Atorvastatin on Stabilization of Coronary Plaque - Evaluation by Optical Coherence Tomography (OCT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • Fibrous cap thickness by OCT [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • macrophage number [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atorvastatin 20mg
 Drug: high-dose atorvastatin
20mg/day
Other Name: Lipitor20
Active Comparator: 2
atorvastatin 5mg
 Drug: low-dose atorvastatin
5mg/day
Other Name: Lipitor5

Detailed Description:

Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI and have at least one atherosclerotic lesion of >25% stenosis other than culprit lesions of current ACS are enrolled. Fibrous cap thickness of a target coronary plaque is evaluated by optical coherence tomography.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI.
  • plasma LDL cholesterol levels : >=100mg/dL and ≤160mg/dL
  • at least one atherosclerotic lesion of >25% stenosis other than culprit lesions of current ACS

Exclusion Criteria:

  • Patients who will undergo coronary bypass surgery.
  • Patients with major complications during treatment of culprit coronary lesions.
  • Patients with an atherosclerotic lesion with >50% stenosis at a left main trunk.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700037

Contacts
Contact: Takashi Akasaka +81-73-447-2300 ext 5165 akasat@wakayama-med.ac.jp

Locations
Japan
Wakayama Medical University Recruiting
Wakayama, Japan, 641-8509
Contact: Takashi Akasaka         akasat@wakayama-med.ac.jp    
Sponsors and Collaborators
Wakayama Medical University
Investigators
Principal Investigator: Takashi Akasaka Wakayama Medical University
  More Information

No publications provided

Responsible Party: Takashi Akasaka, Professor of Cardiovascular Medicine, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00700037     History of Changes
Other Study ID Numbers: wakayamamu08-001
Study First Received: June 13, 2008
Last Updated: June 13, 2008
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Atherosclerosis
Dyslipidemias
Acute Coronary Syndrome
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Chest Pain
 Pain
Signs and Symptoms
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013