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This is a prospective, randomized trial comparing different doses of rosuvastatin in patients with acute coronary syndrome post drug-eluting stents implantation. Through the study, the investigators aim to evaluate the effects of high dose rosuvastatin calcium on "target vessel" endothelialization and "non-target vessel" plaque stability. Moreover, the investigators may provide mechanically evidence of clinical application of high dose rosuvastatin in patients with acute coronary syndrome.
This is a prospective, multicenter, randomized controlled clinical trial comparing different doses of rosuvastatin in patients with acute coronary syndrome post drug-eluting stents implantation. In total, the investigators plan to recruit 80 patients with acute coronary syndrome (but no acute ST-segment elevation myocardial infarction) participating in the study. After signing informed consent form, the patients will be randomly assigned into high dose rosuvastatin and low dose rosuvastatin groups (40 cases in each group) by a computer generated random sequence table on a ratio of 1:1. Patients in the high-dose group will be prescribed rosuvastatin calcium of 20mg/d at least 6 months post index procedure, while patients in low dose group will have rosuvastatin calcium of 10mg/d, also at least 6 months. Additionally, all patients will receive dual antiplatelet therapy (oral aspirin 100mg qd, clopidogrel 75mg qd or ticagrelor 90 mg bid). Clinical follow up (telephone or out-patient follow-up) will be scheduled at 30 days, 6 months, 1 year, 2 years and 3 years. Optical coherence tomography examinations will be performed at 6 months. Neointimal hyperplasia, stent strut coverage and thin cap fibroatheroma are primary observational parameters. Multi-slices CT are optional pre-/post-procedure and at 3 years follow-up. All clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee. All imaging modalities data will be collected and analysed by an independent imaging core laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose rosuvastatin | Experimental | 20mg/d quaque nocte(qN), at least 6 months |
|
| Low dose rosuvastatin | Active Comparator | 10mg/d quaque nocte(qN), at least 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose Rosuvastatin | Drug | 20mg/d qN, at least 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of covered struts | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean/Minimal stent diameter | 6 months | |
| Mean/Minimal stent area | 6 months | |
| Mean/Minimal stent volume |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid levels | Total cholesterol(TC),low density lipoprotein(LDL),high density lipoprotein(HDL),LDL/HDL,triglyceride | Baseline,6 months |
| Biological index | High sensitivity c-reactive protein(hs-CRP),Pentraxin-3(PTX-3),Vascular cell adhesion molecule-1(VCAM-1),Matrix metallopeptidase-9(MMP-9) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong-Xiang Zhu, MSc | Contact | zhuyongxiang_njmu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yao-Jun Zhang, PhD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Ze-Ning Jin, PhD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital, Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17903626 | Background | Morice MC, Serruys PW, Barragan P, Bode C, Van Es GA, Stoll HP, Snead D, Mauri L, Cutlip DE, Sousa E. Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial. J Am Coll Cardiol. 2007 Oct 2;50(14):1299-304. doi: 10.1016/j.jacc.2007.06.029. Epub 2007 Sep 17. | |
| 12750213 | Background |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Low dose Rosuvastatin | Drug | 10mg/d qN, at least 6 months |
|
|
| 6 months |
| Mean/Minimal lumen diameter | 6 months |
| Mean/Minimal lumen area | 6 months |
| Mean/Minimal lumen volume | 6 months |
| Mean/Minimal vessel diameter | 6 months |
| Mean/Minimal vessel area | 6 months |
| Mean/Minimal vessel volume | 6 months |
| Mean/Minimal thickness of stent strut coverage | 6 months |
| thin cap fibroatheroma(TCFA) | 6 months |
| Cap thickness of thin cap fibroatheroma(TCFA) | 6 months |
| Neointimal Hyperplasia area | 6 months |
| Neointimal Hyperplasia volume | 6 months |
| Incomplete strut apposition | 6 months |
| Device-oriented composite endpoint | 1 and 6 months, 1, 2, 3 years |
| Cardiac death | 1 and 6 months, 1, 2, 3 years |
| Non-fatal myocardial infarction | 1 and 6 months, 1, 2, 3 years |
| All revascularization | 1 and 6 months, 1, 2, 3 years |
| target lesion revascularization | 1 and 6 months, 1, 2, 3 years |
| target vessel revascularization | 1 and 6 months, 1, 2, 3 years |
| stent thrombosis | 1 and 6 months, 1, 2, 3 years |
| Baseline,6 months |
| Fei Ye, PhD |
| The First Affiliated Hospital with Nanjing Medical University |
| Principal Investigator |
| Song Lin, PhD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Bo Xu, MSc | Fu Wai Hospital, Beijing, China | Study Director |
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| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |