Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01086020

Acronym

AEPP

Enrollment

400

Registered

2010-03-12

Start date

2010-01-31

Completion date

2012-12-31

Last updated

2011-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

IVUS, coronary plaque, regression

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.

Interventions

DRUGatorvastatin

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

DRUGatorvastatin plus ezetimibe

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Willing to receive the coronary angiography and potential PCI therapy

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
change of coronary artery plaque volume	1 year	The primary endpoint was the change of coronary artery plaque volume measured by intravascular ultrasound (IVUS) at one year after randomization.

Secondary

Measure	Time frame	Description
composite of adverse cardiac events	2 years	The secondary endpoint was the composite of adverse cardiac events (MACE), including cardiac death, non-fatal infarction and target vessel revascularization at two years after randomization.

Countries

China

Contacts

Primary ContactRuiyan Zhang, MD

zhangruiyan@263.net862164370045

Backup Contactxin Chen, MD

862164370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026