Status:
UNKNOWN
Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With Non ST-segment Elevated Acute Coronary Syndrome(NSTE-ACS)
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Non-ST-elevation Acute Coronary Syndromes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
Non ST-segment elevated acute coronary syndrome(NSTE-ACS) is increasing rapidly, and is more frequent than ST-segment elevated acute coronary syndrome (STE-ACS) now. NSTE-ACS patients sent to early PC...
Eligibility Criteria
Inclusion
- 18-80 year old males and non-child-bearing period females.
- 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.
- Received early (within 48 h) Percutaneous Coronary Intervention(PCI).
- Should be statin- naïve(last 3 months).
- Only receive drug-eluting stents.
- Sign the Informed Consent Form(ICF)
Exclusion
- Any of the following is regarded as a criterion for exclusion from the study:
- Diagnosis as STEMI;
- NSTE-ACS with high-risk features warranting emergency coronary angiography;
- Receive only medical therapy or Coronary Artery Bypass Graft(CABG)
- Active liver disease or dysfunction including agnogenic serum transaminase sustained elevation or higher than 3 times upper limit of normal(ULN);
- Left ventricular ejection fraction\<30%;
- Previous or current treatment with statins;
- Patients with myopathy or serum creatine kinase \> 5 times the upper limit of normal not caused by myocardial injury;
- Severe renal function damage (creatinine clearance rate\<30 ml/min);
- Severe anemia (haemoglobin\< 6g/L);
- Diagnosed with malignancy within 5 years;
- Concurrent use ciclosporin；
- Investigator evaluated as not appropriate for statins.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
1350 Patients enrolled
Trial Details
Trial ID
NCT02284503
Start Date
November 1 2014
End Date
June 1 2016
Last Update
November 6 2014
Active Locations (1)
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1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032