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

Primary Purpose

Non-ST-elevation Acute Coronary Syndromes

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Rosuvastatin

About this trial

This is an interventional treatment trial for Non-ST-elevation Acute Coronary Syndromes focused on measuring MI reduction, intensive statin treatment, NSTE-ACS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Zhongshan Hospital Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

40mg Rosuvastatin group

20mg Rosuvastatin group

no statin group

Arm Description

The subjects in this group will receive Rosuvastatin 40mg within 12±2h before PCI, follow 20mg post PCI for 30days.

The subjects in this group will receive Rosuvastatin 20mg within 12±2h before PCI, follow 20mg post PCI for 30days.

The subjects in this group will not receive Rosuvastatin before PCI, follow 10mg post PCI for 30days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

MACE reduction

Major Adverse Cardiac Events(MACE) event including death, Myocardial infarction(MI), target vessel revascularization, ischemic stroke

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.

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.

Full Information

NCT ID

NCT02284503

First Posted

October 30, 2014

Last Updated

November 3, 2014

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02284503

Brief Title

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

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-ST-elevation Acute Coronary Syndromes

Keywords

MI reduction, intensive statin treatment, NSTE-ACS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

40mg Rosuvastatin group

Arm Type

Experimental

Arm Description

The subjects in this group will receive Rosuvastatin 40mg within 12±2h before PCI, follow 20mg post PCI for 30days.

Arm Title

20mg Rosuvastatin group

Arm Type

Experimental

Arm Description

The subjects in this group will receive Rosuvastatin 20mg within 12±2h before PCI, follow 20mg post PCI for 30days.

Arm Title

no statin group

Arm Type

Experimental

Arm Description

The subjects in this group will not receive Rosuvastatin before PCI, follow 10mg post PCI for 30days.

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

Rosuvastatin Calcium Tablets

Intervention Description

The subjects will receive intensive Rosuvastatin before and after PCI

Primary Outcome Measure Information:

Title

myocardial injury reduction

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

MACE reduction

Description

Major Adverse Cardiac Events(MACE) event including death, Myocardial infarction(MI), target vessel revascularization, ischemic stroke

Time Frame

30 days

Title

the change of lipid

Description

Time Frame

30 days

Title

the change of hsCRP

Description

The change of inflammatory marker High sensitivity C-reactive protein(hsCRP) between Rosuvastatin 10 mg/day and 20 mg/day treatment at 30 days.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yinman Wang, Master

Phone

+86 21 64041990

Ext

2521

wang.yinman@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junbo Ge, M.D.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yinman Wang, Master

Phone

+86 21 64041990

Ext

2521

wang.yinman@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Junbo Ge, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20558366

Citation

Yeh RW, Sidney S, Chandra M, Sorel M, Selby JV, Go AS. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med. 2010 Jun 10;362(23):2155-65. doi: 10.1056/NEJMoa0908610.

Results Reference

result

PubMed Identifier

15277322

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.

Results Reference

result

PubMed Identifier

20825761

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.

Results Reference

result

PubMed Identifier

20471117

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.

Results Reference

result

PubMed Identifier

18706705

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.

Results Reference

result

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.

Results Reference

result

Learn more about this trial

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

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