Ezetimibe and Atorvastatin Therapy on TCFA

Impact of Combined Ezetimibe and Atorvastatin Therapy on Coronary Thin-cap Fibroatheroma As Assessed by Optical Coherence Tomography

After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method. Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Ezetimibe and Atorvastatin; Drug: Atorvastatin

Detailed Description

This is a prospective, randomized , controlled, open-label, single-center study to evaluate the effect of ezetimibe added to atorvastatin on coronary thin-cap fibroatheroma(TCFA). After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method.

Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months.The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.The secondary endpoints include absolute and percent changes in the lipid, glycemic, and inflammatory profile. Then, changes of these indicators above will be compared respectively in diabetic and non-diabetic patients.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital, Fourth Military Medical University
      • Contact: Dongdong Sun, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1.stable angina or acute coronary syndrome 2.18-80 years old 3.hypercholesterolemia :total cholesterol level >220 mg/dl (5.7mmol/L) and/or LDL-C level >140 mg/dl(3.6mmol/L), or previously receiving statins therapy 4. the target vessel for OCT interrogation has not undergone angioplasty and has angiographic diameter stenosis from 25% to 75% 5.There are TCFAs in non-culprit, mild-to-moderate stenotic lesions above

Exclusion Criteria:

1. administration of lipid-lowering drugs other than statins before enrollment
2. significant stenotic lesions in all coronary vessels
3. severe congestive heart failure (New York Heart Association class IV) ,or left ventricular ejection fraction<35%
4. more than 3 times of the upper limit of normal (ULN) in the creatine kinase (CK) and the transaminase level before enrollment and no relation with myocardial infarction
5. renal failure (serum creatinine>2.0 mg/dL）
6. hypersensitivity to x-ray contrast media, statin，clopidogrel or ezetimibe
7. Others: terminal stage cancer,a positive pregnancy test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ezetimibe and Atorvastatin Therapy; Atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）	Drug: Ezetimibe and Atorvastatin; atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）; Other Names: Ezetrol and lipitor
Active Comparator: Atorvastatin Therapy; Atorvastatin (20 mg/day）	Drug: Atorvastatin; atorvastatin (20 mg/day）; Other Names: Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
minimum fibrous cap thickness	The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.	12months

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Yan Li, M.D., Ph.D., Xijing Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Estimate): October 27, 2015
• Last Update Submitted That Met QC Criteria: October 26, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Ezetimibe
• Other Study ID Numbers: TCFA-OCT XIJING01