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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe and Atorvastatin Therapy | Experimental | Atorvastatin (20 mg/day)plus ezetimibe(10 mg/day) |
|
| Atorvastatin Therapy | Active Comparator | Atorvastatin (20 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe and Atorvastatin | Drug | atorvastatin (20 mg/day)plus ezetimibe(10 mg/day) |
|
| 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 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongdong Sun, M.D., Ph.D. | Contact | 86 29 84775183 | 51483696@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Li, M.D., Ph.D. | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Atorvastatin | Drug | atorvastatin (20 mg/day) |
|
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D011758 |
| Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |