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

November 3, 2014 updated by: Shanghai Zhongshan Hospital

A 30-day, Randomized, Open-Label, Multicenter Study Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With NSTE-ACS

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Rosuvastatin Calcium Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE reduction
Time Frame: 30 days
Major Adverse Cardiac Events(MACE) event including death, Myocardial infarction(MI), target vessel revascularization, ischemic stroke
30 days
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.
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSCRES0169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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