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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Shanghai Zhongshan Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284503
First Posted: November 6, 2014
Last Update Posted: November 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
  Purpose
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.

Condition Intervention Phase
Non-ST-elevation Acute Coronary Syndromes Drug: Rosuvastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 30-day, Randomized, Open-Label, Multicenter Study Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With NSTE-ACS

Resource links provided by NLM:


Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • myocardial injury reduction [ Time Frame: 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:
  • MACE reduction [ Time Frame: 30 days ]
    Major Adverse Cardiac Events(MACE) event including death, Myocardial infarction(MI), target vessel revascularization, ischemic stroke

  • the change of lipid [ Time Frame: 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.

  • the change of hsCRP [ Time Frame: 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.


Estimated Enrollment: 1350
Study Start Date: November 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40mg Rosuvastatin group
The subjects in this group will receive Rosuvastatin 40mg within 12±2h before PCI, follow 20mg post PCI for 30days.
Drug: Rosuvastatin
The subjects will receive intensive Rosuvastatin before and after PCI
Other Name: Rosuvastatin Calcium Tablets
Experimental: 20mg Rosuvastatin group
The subjects in this group will receive Rosuvastatin 20mg within 12±2h before PCI, follow 20mg post PCI for 30days.
Drug: Rosuvastatin
The subjects will receive intensive Rosuvastatin before and after PCI
Other Name: Rosuvastatin Calcium Tablets
Experimental: no statin group
The subjects in this group will not receive Rosuvastatin before PCI, follow 10mg post PCI for 30days.
Drug: Rosuvastatin
The subjects will receive intensive Rosuvastatin before and after PCI
Other Name: Rosuvastatin Calcium Tablets

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284503


Contacts
Contact: Yinman Wang, Master +86 21 64041990 ext 2521 wang.yinman@zs-hospital.sh.cn

Locations
China, Shanghai
Zhongshan Hospital Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Yinman Wang, Master    +86 21 64041990 ext 2521    wang.yinman@zs-hospital.sh.cn   
Principal Investigator: Junbo Ge, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Principal Investigator: Junbo Ge, M.D. Fudan University
  More Information

Publications:
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.

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02284503     History of Changes
Other Study ID Numbers: ISSCRES0169
First Submitted: October 30, 2014
First Posted: November 6, 2014
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by Shanghai Zhongshan Hospital:
MI reduction
intensive statin treatment
NSTE-ACS

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors