Non-ST-elevation Acute Coronary Syndromes Clinical Trial
Official title:
A 30-day, Randomized, Open-Label, Multicenter Study Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With NSTE-ACS
This is a 30-day, randomized, open-label, 3-arm, parallel-group, multicenter study exploring efficacy of intensive rosuvastatin treatment peri-PCI in Chinese patients with NSTE-ACS.
| Status | Not yet recruiting |
| Enrollment | 1350 |
| Est. completion date | June 2016 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: 1. 18-80 year old males and non-child-bearing period females. 2. Clinical diagnosed with NSTE-ACS, including unstable angina or non-ST-segment elevation myocardial infarction(NSTEMI). - For unstable angina, the diagnose should meet all below: Clinical onset features: angina for at least 20 min when resting; initial onset angina pectoris(new onset within one month) manifests spontaneous angina or labor angina (CCS grade II or III); Symptoms of original stable angina pectoris aggravate in one month and at least achieve CCS grade III (accelerated angina pectoris); angina onset within one month after MI. ECG: At least twice in one month: ST depression or elevation >0.1millivolt (mv) or T-wave inversion =0.2 mv in 2 or more contiguous electrocardiographic leads when onset and the ST-T changes recovered after remission of chest pain. Myocardial damage marker do not elevate or reach the MI diagnostic level. - For NSTEMI, the diagnose should meet all below ischemia symptoms(ischemic chest pain lasting more than 30 min and cannot relief significantly by sub-lingual NTG) ECG change: new ST-T dynamic development (new or transient ST depression =0.1mv or T-wave inversion=0.2mv). Myocardial damage marker level is normal or elevated to the MI diagnostic level. 3. Received early (within 48 h) Percutaneous Coronary Intervention(PCI). 4. Should be statin- naïve(last 3 months). 5. Only receive drug-eluting stents. 6. Sign the Informed Consent Form(ICF) Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Diagnosis as STEMI; 2. NSTE-ACS with high-risk features warranting emergency coronary angiography; 3. Receive only medical therapy or Coronary Artery Bypass Graft(CABG) 4. Active liver disease or dysfunction including agnogenic serum transaminase sustained elevation or higher than 3 times upper limit of normal(ULN); 5. Left ventricular ejection fraction<30%; 6. Previous or current treatment with statins; 7. Patients with myopathy or serum creatine kinase > 5 times the upper limit of normal not caused by myocardial injury; 8. Severe renal function damage (creatinine clearance rate<30 ml/min); 9. Severe anemia (haemoglobin< 6g/L); 10. Diagnosed with malignancy within 5 years; 11. Concurrent use ciclosporin; 12. Investigator evaluated as not appropriate for statins. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Zhongshan Hospital Fudan University | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Zhongshan Hospital |
China,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | myocardial injury reduction | Myocardial injury assessed by creatine kinase-MB. (CK-MB) elevation, defined as a post-procedural elevation of CK-MB values >3×99th percentile Upper Reference Limit (URL) in patients with normal baseline values >99th percentile URL or a rise of CK-MB values>20% if the baseline values are elevated and are stable or falling; or assessed by cTn elevation, defined as a post-procedural elevation of cardiac troponin (cTn) values >5×99th percentile URL in patients with normal baseline values >99th percentile URL or a rise of cTn values>20% if the baseline values are elevated and are stable or falling. | 30 days | No |
| Secondary | MACE reduction | Major Adverse Cardiac Events(MACE) event including death, Myocardial infarction(MI), target vessel revascularization, ischemic stroke | 30 days | No |
| Secondary | the change of lipid | the change of lipid marker, including Low-density lipoprotein cholesterol(LDL-C), total cholesterol(TC), High-density lipoprotein cholesterol(HDL-C), triglyceride(TG), non-HDL-C, between Rosuvastatin 10 mg/day and 20 mg/day treatment at 30 days. | 30 days | No |
| Secondary | the change of hsCRP | The change of inflammatory marker High sensitivity C-reactive protein(hsCRP) between Rosuvastatin 10 mg/day and 20 mg/day treatment at 30 days. | 30 days | No |