We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

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.
ClinicalTrials.gov Identifier: NCT01372930
Recruitment Status : Unknown
Verified March 2010 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : June 14, 2011
Last Update Posted : June 14, 2011
Information provided by:
Xijing Hospital

June 10, 2011
June 14, 2011
June 14, 2011
April 2010
July 2014   (Final data collection date for primary outcome measure)
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke [ Time Frame: 30 days ]
Same as current
No Changes Posted
  • Composite endpoint of major cardiovascular events, non-elective coronary revascularization procedures and hospitalization for unstable angina Cardiovascular death Non-fatal myocardial infarction Non-fatal stroke of all classifications [ Time Frame: 30 days ]
  • Elevation of ALT, AST and CK [ Time Frame: 30 days ]
  • serum adiponectin concentration, activity and isoforms [ Time Frame: 30 days ]
Same as current
Not Provided
Not Provided
Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction
The Safety and Efficacy of Etanercept in Treating Patient With Acute ST Segment Elevated Myocardial Infarction
Our aim is to observe whether anti-TNF-alpha regimen will effect serum adiponectin concentration after myocardial infarction/reperfusion and also beneficial for the patients undergoing percutaneous coronary intervention (PCI).
Ischemic/reperfusion injury in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) is associated with increased inflammatory cytokines that including TNF-alpha that can exert deleterious effects and therefore contribute to cardiac dysfunction and cardiomyocytes apoptosis. Several studies on rodents have reported administration of sTNFR-Fc, a scavenger of the pro-inflammatory cytokine TNF-alpha at the time of reperfusion would protect against ischemic/reperfusion injury. Also reports had shown that serum TNF-alpha concentration is negatively correlated with a cardioprotective cytokine adiponectin. Adiponectin (Ad) is an abundant protein hormone regulatory of numerous metabolic processes. The major intracellular pathway activated by Ad includes phosphorylation of AMP-activated protein kinase, which is responsible for many of Ad's metabolic regulatory, anti-inflammatory, vascular protective, and anti-ischemic properties. The aim of the present study was to verify whether the administration of Etanercept, an FDA approved rheumatoid arthritis treating sTNFR-Fc, at the reperfusion time would protect against ischemic/reperfusion injury on patient, and effect serum adiponectin level.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myocardial Infarction
  • Drug: Etanercept
    Etanercept 25mg in 1ml(subcutaneous injection)at 2h and 72h after PCI
    Other Name: Enbrel
  • Drug: saline
    saline 1ml(subcutaneous injection) at 2h and 72h after PCI
  • Experimental: Etanercept
    Intervention: Drug: Etanercept
  • Placebo Comparator: saline
    Intervention: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
Not Provided
July 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with acute ST segment elevated myocardial infarction in 12h

Exclusion Criteria:

  • Cardiogenic shock
  • old myocardial infarction
  • other causes of cardiac insufficiency
  • tumor
  • Coronary anatomy unsuitable for PCI or Need of emergency coronary artery by-pass grafting
  • Pregnancy
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Ling Tao, Department of Cardiology of Xijing Hospital; Fourth Military Medical University
Xijing Hospital
Not Provided
Not Provided
Xijing Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP