- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02588235
Ezetimibe and Atorvastatin Therapy on TCFA
Impact of Combined Ezetimibe and Atorvastatin Therapy on Coronary Thin-cap Fibroatheroma As Assessed by Optical Coherence Tomography
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Dongdong Sun, M.D., Ph.D.
- Phone Number: 86 29 84775183
- Email: 51483696@qq.com
Study Locations
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ezetimibe and Atorvastatin Therapy
Atorvastatin (20 mg/day)plus ezetimibe(10 mg/day)
|
atorvastatin (20 mg/day)plus ezetimibe(10 mg/day)
Other Names:
|
Active Comparator: Atorvastatin Therapy
Atorvastatin (20 mg/day)
|
atorvastatin (20 mg/day)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minimum fibrous cap thickness
Time Frame: 12months
|
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
Investigators
- Principal Investigator: Yan Li, M.D., Ph.D., Xijing Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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