Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With Non ST-segment Elevated Acute Coronary Syndrome(NSTE-ACS)

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Rosuvastatin Calcium

Criteria

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.