Efficacy of Early Administration of Clotinab in Acute Myocardial Infarction

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 acute myocardial infarction prior to PCI improves clinical outcomes but no specifically designed randomized study has addressed the issue of early upstream use of GP IIb/IIIa inhibitors in ST elevation acute myocardial infarction who are undergoing PCI, especially in the era of routine pretreatment with 600 mg of clopidogrel. Therefore, the objective of the randomized ECLAT-STEMI study was to assess the hypothesis that the early upstream use of Clotinab is a useful therapy in patients with ST elevation MI undergoing PCI compared to "provisional use", even after pretreatment with a 600-mg loading dose of clopidogrel.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Collaborator: ISU ABXIS (Korea pharmaceutical company)
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

1. The patient must be at least 18-80 years of age.

2. 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.

3. The patient or guardian agrees to the study protocol and provides informed, written consent.

Exclusion Criteria:

1. Patients to whom PCI can not be undergone within 12 hours from receiving the study drug

2. Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg

3. The history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal or genitourinary bleeding within recent 6 weeks;

4. History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit

5. Severe or malignant hypertension (= sitting SBP > 180 mmHg and/or sitting DBP > 105 mmHg)

6. The patients who require oral anticoagulants during the trial; patients who have been administrated oral anticoagulants within 7 days

7. 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)

8. The patients who could not take anti-platelet drugs

9. The patients who might die of other disease than cardiac disease during the trial.