Clinical trial NCT02284503: Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With Non ST-segment Elevated Acute Coronary Syndrome(NSTE-ACS)
Official title: A 30-day, Randomized, Open-Label, Multicenter Study Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With NSTE-ACS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-ST-elevation Acute Coronary Syndromes
Keywords: MI reduction
intensive statin treatment
NSTE-ACS
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: myocardial injury reduction
timeFrame: 30 days
Secondary outcomes:
measure: MACE reduction
timeFrame: 30 days
measure: the change of lipid
timeFrame: 30 days
measure: the change of hsCRP
timeFrame: 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Junbo Ge, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2004 Aug 10;110(6):674-8. doi: 10.1161/01.CIR.0000137828.06205.87. Epub 2004 Jul 26.
citation: Winchester DE, Wen X, Xie L, Bavry AA. Evidence of pre-procedural statin therapy a meta-analysis of randomized trials. J Am Coll Cardiol. 2010 Sep 28;56(14):1099-109. doi: 10.1016/j.jacc.2010.04.023. Epub 2010 Aug 31.
citation: Yun KH, Oh SK, Rhee SJ, Yoo NJ, Kim NH, Jeong JW. 12-month follow-up results of high dose rosuvastatin loading before percutaneous coronary intervention in patients with acute coronary syndrome. Int J Cardiol. 2011 Jan 7;146(1):68-72. doi: 10.1016/j.ijcard.2010.04.052. Epub 2010 May 14.
citation: Yun KH, Jeong MH, Oh SK, Rhee SJ, Park EM, Lee EM, Yoo NJ, Kim NH, Ahn YK, Jeong JW. The beneficial effect of high loading dose of rosuvastatin before percutaneous coronary intervention in patients with acute coronary syndrome. Int J Cardiol. 2009 Nov 12;137(3):246-51. doi: 10.1016/j.ijcard.2008.06.055. Epub 2008 Aug 15.
citation: Gao yuan et al. Comparison of Effects of Loading Dose Rosuvastatin VERSUS Atorvastatin Therapy in Non-ST Segment Elevation Acute Coronary Syndrome Patients. Journal of China Medical University. 2013; 42:235-239.