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

Phase 4

• Conditions: Non-ST-elevation Acute Coronary Syndromes
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT02284503
• Lead Sponsor: Shanghai Zhongshan Hospital

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 PCI procedure is large and increasing rapidly in China.Quite a few trials have focused on high loading dose statin before PCI to improve cardiovascular outcomes in ACS. In Asian, high loading dose statin therapy showed different outcome. Rosuvastatin (RSV) is one of the most potent statins.Nowadays, quite a few experts think ACS patients undergoing PCI not only need loading dose statin, but also post PCI intensive statin treatment is rather important. Chinese consensus and western guidelines recommend intensive statin treatment in these patients. However, Chinese consensus referred to the western study as there's no relevant intensive statin treatment peri-PCI study in China until now.

Thus this study is designed to explore the efficacy of intensive statin treatment peri-PCI (early loading dose-RSV 40 mg or 20mg before PCI and subsequent 20mg post PCI) in periprocedural myocardial injury and 30 days MACE reduction in Chinese NSTE-ACS patients and explore efficacy of 30-day RSV 20 mg post-PCI treatment in lipid profile, inflammatory factors compared with baseline.

Study Timeline

• Study First Submitted: 2014-10-30
• Status Verified: 2014-11
• Study Start: 2014-11
• Study First Submitted QC: 2014-11-03
• Last Update Submitted: 2014-11-03
• Study First Posted: 2014-11-06
• Last Update Posted: 2014-11-06
• Primary Completion: 2014-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40mg Rosuvastatin group	Rosuvastatin	The subjects in this group will receive Rosuvastatin 40mg within 12±2h before PCI, follow 20mg post PCI for 30days.
20mg Rosuvastatin group	Rosuvastatin	The subjects in this group will receive Rosuvastatin 20mg within 12±2h before PCI, follow 20mg post PCI for 30days.
no statin group	Rosuvastatin	The subjects in this group will not receive Rosuvastatin before PCI, follow 10mg post PCI for 30days.

Primary Outcome Measures

Name	Time	Method
myocardial injury reduction	30 days	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.

Secondary Outcome Measures

Name	Time	Method
MACE reduction	30 days	Major Adverse Cardiac Events(MACE) event including death, Myocardial infarction(MI), target vessel revascularization, ischemic stroke
the change of hsCRP	30 days	The change of inflammatory marker High sensitivity C-reactive protein(hsCRP) between Rosuvastatin 10 mg/day and 20 mg/day treatment at 30 days.
the change of lipid	30 days	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.

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China