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

NCT02284503 | Unknown Phase 4

• 1 other identifier: ISSCRES0169
• Study Type: interventional
• Target: 1,350
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-ST-elevation Acute Coronary Syndromes

Keywords

MI reduction; intensive statin treatment; NSTE-ACS

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (3)

• MACE reduction

  30 days

• the change of lipid

  30 days

• the change of hsCRP

  30 days

Study Arms (3)

40mg Rosuvastatin group

EXPERIMENTAL

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

Drug: Rosuvastatin

20mg Rosuvastatin group

EXPERIMENTAL

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

Drug: Rosuvastatin

no statin group

EXPERIMENTAL

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

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

The subjects will receive intensive Rosuvastatin before and after PCI

Also known as: Rosuvastatin Calcium Tablets

20mg Rosuvastatin group; 40mg Rosuvastatin group; no statin group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (6)

• 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.

  PMID: 20558366 RESULT

• 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.

  PMID: 15277322 RESULT

• 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.

  PMID: 20825761 RESULT

• 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.

  PMID: 20471117 RESULT

• 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.

  PMID: 18706705 RESULT

• 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.

  RESULT

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Junbo Ge, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinman Wang, Master

CONTACT

+86 21 64041990; wang.yinman@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 6, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2016
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

CN (1)