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Ezetimibe and Atorvastatin Therapy on TCFA

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ezetimibe and Atorvastatin

Atorvastatin

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

administration of lipid-lowering drugs other than statins before enrollment
significant stenotic lesions in all coronary vessels
severe congestive heart failure (New York Heart Association class IV) ,or left ventricular ejection fraction<35%
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
renal failure (serum creatinine>2.0 mg/dL）
hypersensitivity to x-ray contrast media, statin，clopidogrel or ezetimibe
Others: terminal stage cancer,a positive pregnancy test

Sites / Locations

Xijing Hospital, Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ezetimibe and Atorvastatin Therapy

Atorvastatin Therapy

Arm Description

Atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）

Atorvastatin (20 mg/day）

Outcomes

Primary Outcome Measures

minimum fibrous cap thickness

The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.

Secondary Outcome Measures

Full Information

NCT ID

NCT02588235

First Posted

October 26, 2015

Last Updated

October 26, 2015

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02588235

Brief Title

Ezetimibe and Atorvastatin Therapy on TCFA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ezetimibe and Atorvastatin Therapy

Arm Type

Experimental

Arm Description

Atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）

Arm Title

Atorvastatin Therapy

Arm Type

Active Comparator

Arm Description

Atorvastatin (20 mg/day）

Intervention Type

Drug

Intervention Name(s)

Ezetimibe and Atorvastatin

Other Intervention Name(s)

Ezetrol and lipitor

Intervention Description

atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Other Intervention Name(s)

Lipitor

Intervention Description

atorvastatin (20 mg/day）

Primary Outcome Measure Information:

Title

minimum fibrous cap thickness

Description

The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.

Time Frame

12months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: administration of lipid-lowering drugs other than statins before enrollment significant stenotic lesions in all coronary vessels severe congestive heart failure (New York Heart Association class IV) ,or left ventricular ejection fraction<35% 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 renal failure (serum creatinine>2.0 mg/dL） hypersensitivity to x-ray contrast media, statin，clopidogrel or ezetimibe Others: terminal stage cancer,a positive pregnancy test

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dongdong Sun, M.D., Ph.D.

Phone

86 29 84775183

51483696@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan Li, M.D., Ph.D.

Organizational Affiliation

Xijing Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital, Fourth Military Medical University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dongdong Sun, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Ezetimibe and Atorvastatin Therapy on TCFA

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