Status:

COMPLETED

Efficacy of Early Administration of Clotinab in Acute Myocardial Infarction

Lead Sponsor:

Yonsei University

Collaborating Sponsors:

ISU ABXIS (Korea pharmaceutical company)

Conditions:

Myocardial Infarction

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

Brief Summary

The ADMIRAL (Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction) study demonstrated that early administration of abciximab in patients with ST elevation a...

Detailed Description

It is well known that platelet-mediated thrombosis is account for the pathophysiology of acute coronary syndrome (ACS) (1,2). In the treatment of ACS, intravenous platelet glycoprotein (GP) IIb/IIIa r...

Eligibility Criteria

Inclusion

  • The patient must be at least 18-80 years of age.
  • The patient had the symptoms of acute myocardial infarction within 12 hours with ST segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB.
  • The patient or guardian agrees to the study protocol and provides informed, written consent.

Exclusion

  • Patients to whom PCI can not be undergone within 12 hours from receiving the study drug
  • Cardiogenic shock or symptomatic hypotension or sitting SBP \< 95 mmHg
  • The history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal or genitourinary bleeding within recent 6 weeks;
  • History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
  • Severe or malignant hypertension (= sitting SBP \> 180 mmHg and/or sitting DBP \> 105 mmHg)
  • The patients who require oral anticoagulants during the trial; patients who have been administrated oral anticoagulants within 7 days
  • The history or diagnosis of vasculitis; renal insufficiency (the level of serum creatinine is two times higher than the upper limit of normal of each center)
  • The patients who could not take anti-platelet drugs
  • The patients who might die of other disease than cardiac disease during the trial.

Key Trial Info

Start Date :

July 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2009

Estimated Enrollment :

786 Patients enrolled

Trial Details

Trial ID

NCT00841438

Start Date

July 1 2007

End Date

December 1 2009

Last Update

May 4 2010

Active Locations (31)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 8 (31 locations)

1

Dankook University Hospital

Cheonan, South Korea, 330-716

2

Chonbuk National University Hospital

Cheonju, South Korea, 561-716

3

Keimyung University Dongsan Medical Center

Daegu, South Korea, 700-712

4

Kyungpook National University Hospital

Daegu, South Korea, 700-721