Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

NCT01086020 | Unknown Phase 4

• 1 other identifier: RJH20100101
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment for patients with coronary artery disease. Studies indicated that coronary artery plaque progression had positive relationship with the plasma cholesterol level, and could be halted or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus statin could further lowered blood cholesterol level. Here the investigators hypothesize that same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin plus ezetimibe could achieve the same effect on coronary artery plaque cessation or regression.

Conditions

Coronary Artery Disease

Keywords

IVUS; coronary plaque; regression

Outcome Measures

Primary Outcomes (1)

• change of coronary artery plaque volume

  The primary endpoint was the change of coronary artery plaque volume measured by intravascular ultrasound (IVUS) at one year after randomization.

  1 year

Secondary Outcomes (1)

• composite of adverse cardiac events

  2 years

Study Arms (2)

atorvastatin

ACTIVE COMPARATOR

patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years

Drug: atorvastatin

atorvastatin and ezetimibe

EXPERIMENTAL

patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years

Drug: atorvastatin plus ezetimibe

Interventions

atorvastatin DRUG

Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years

Also known as: Lipitor

atorvastatin

atorvastatin plus ezetimibe DRUG

Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d for two years

Also known as: Lipitor and ezetrol

atorvastatin and ezetimibe

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to receive the coronary angiography and potential PCI therapy

You may not qualify if:

• Patients was treated by statins before randomization
• Patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion
• ST elevation myocardial infarction less than 7 days
• Without informed consent
• Abnormal liver function before randomization, (AST, ALT ≥ULN)
• Active hepatitis or muscular disease
• Impaired renal function with serum creatinine level \> 3mg/dl
• Impaired left ventricular function with LVEF \> 30%
• Participate in other studies

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital,

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atorvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Azetidines; Azetines

Study Officials

• Weifeng Shen, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruiyan Zhang, MD

CONTACT

862164370045; zhangruiyan@263.net

xin Chen, MD

CONTACT

862164370045

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 12, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: April 4, 2011

Record last verified: 2009-12

Locations

CN (1)