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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
20mg/d qN, at least 6 months
10mg/d qN, at least 6 months
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGProportion of covered struts
Time frame: 6 months
Mean/Minimal stent diameter
Time frame: 6 months
Mean/Minimal stent area
Time frame: 6 months
Mean/Minimal stent volume
Time frame: 6 months
Mean/Minimal lumen diameter
Time frame: 6 months
Mean/Minimal lumen area
Time frame: 6 months
Mean/Minimal lumen volume
Time frame: 6 months
Mean/Minimal vessel diameter
Time frame: 6 months
Mean/Minimal vessel area
Time frame: 6 months
Mean/Minimal vessel volume
Time frame: 6 months
Mean/Minimal thickness of stent strut coverage
Time frame: 6 months
thin cap fibroatheroma(TCFA)
Time frame: 6 months
Cap thickness of thin cap fibroatheroma(TCFA)
Time frame: 6 months
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Enrollment
80
Neointimal Hyperplasia area
Time frame: 6 months
Neointimal Hyperplasia volume
Time frame: 6 months
Incomplete strut apposition
Time frame: 6 months
Device-oriented composite endpoint
Time frame: 1 and 6 months, 1, 2, 3 years
Cardiac death
Time frame: 1 and 6 months, 1, 2, 3 years
Non-fatal myocardial infarction
Time frame: 1 and 6 months, 1, 2, 3 years
All revascularization
Time frame: 1 and 6 months, 1, 2, 3 years
target lesion revascularization
Time frame: 1 and 6 months, 1, 2, 3 years
target vessel revascularization
Time frame: 1 and 6 months, 1, 2, 3 years
stent thrombosis
Time frame: 1 and 6 months, 1, 2, 3 years