NCT01372930

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

June 14, 2011

Status Verified

March 1, 2010

Enrollment Period

4.3 years

First QC Date

June 10, 2011

Last Update Submit

June 11, 2011

Conditions

Myocardial Infarction

Keywords

Etanerceptacute ST segment elevated myocardial infarctionpercutaneous coronary interventionmyocardial reperfusion injury

Outcome Measures

Primary Outcomes (1)

  • Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke

    30 days

Secondary Outcomes (3)

  • 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

  • Elevation of ALT, AST and CK

    30 days

  • serum adiponectin concentration, activity and isoforms

    30 days

Study Arms (2)

Etanercept

EXPERIMENTAL
Drug: Etanercept

saline

PLACEBO COMPARATOR
Drug: saline

Interventions

EtanerceptDRUG

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

Also known as: Enbrel
Etanercept
salineDRUG

saline 1ml(subcutaneous injection) at 2h and 72h after PCI

saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionMyocardial Reperfusion Injury

Interventions

EtanerceptSodium Chloride

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCardiomyopathiesReperfusion InjuryPostoperative Complications

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Ling Tao, M.D Ph.D

CONTACT

+86-15002955798lingtao2006@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 14, 2011

Study Start

April 1, 2010

Primary Completion

July 1, 2014

Last Updated

June 14, 2011

Record last verified: 2010-03

Locations

CN(1)