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Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01372930
First received: June 10, 2011
Last updated: June 11, 2011
Last verified: March 2010

June 10, 2011
June 11, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01372930 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Elevation of ALT, AST and CK [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • serum adiponectin concentration, activity and isoforms [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
200
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
Both
18 Years to 80 Years
No
Contact: Ling Tao, M.D Ph.D +86-15002955798 lingtao2006@gmail.com
China
 
NCT01372930
xjyy110504
No
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