Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

The Safety and Efficacy of Etanercept in Treating Patient With Acute ST Segment Elevated Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01372930
• Other study ID #: xjyy110504
• Status: Recruiting
• Phase: Phase 4
• First received: June 10, 2011
• Last updated: June 11, 2011
• Start date: April 2010

Study information

• Verified date: March 2010
• Source: Xijing Hospital
• Contact: Ling Tao, M.D Ph.D
• Phone: +86-15002955798
• Email: lingtao2006[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Etanercept
Etanercept 25mg in 1ml(subcutaneous injection)at 2h and 72h after PCI
• saline
saline 1ml(subcutaneous injection) at 2h and 72h after PCI

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke		30 days	Yes
Secondary	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		30 days	Yes
Secondary	Elevation of ALT, AST and CK		30 days	No
Secondary	serum adiponectin concentration, activity and isoforms		30 days	No