Efficacy of Early Administration of Clotinab in Acute Myocardial Infarction

NCT00841438 | Completed Phase 4 DMC

• 1 other identifier: ISU-CLT-07001
• Study Type: interventional
• Target: 786
• Locations: 1 country
• Sites: 31

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 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.

Conditions

Myocardial Infarction

Keywords

Angioplasty; Transluminal; Percutaneous Coronary

Outcome Measures

Primary Outcomes (1)

• MACCE (death, MI, TVR, cerebrovascular event)

  30 days

Secondary Outcomes (3)

• MACCE (death, MI, TVR, cerebrovascular event)

  9 months

• TIMI flow at before and after PCI

  Immediate post procedure

• Corrected TIMI frame count after PCI

  Immediate postprocedure

Study Arms (2)

Provisional use of Clotinab

ACTIVE COMPARATOR

Provisional use of clotinab

Drug: Clotinab

Upstream use of clotinab

EXPERIMENTAL

early upstream use of clotinab

Drug: Clotinab

Interventions

Clotinab DRUG

Clotinab: IV bolus 0.25 mg per Kg and a 12-hour IV infusion 0.125 μg per kg

Also known as: Clotinab, Gp IIb/IIIa inhibitor

Provisional use of Clotinab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead
• ISU ABXIS (Korea pharmaceutical company): collaborator

Study Sites (31)

Dankook University Hospital

Cheonan, 330-716, South Korea

Location

Chonbuk National University Hospital

Cheonju, 561-716, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Yeungnam University Hospital

Daegu, 705-717, South Korea

Location

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Goyang, 410-719, South Korea

Location

Dongguk University International Hospital

Goyang, 410-773, South Korea

Location

Myongji Hospital

Goyang, 412-270, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-759, South Korea

Location

Pusan National University Hospital

Pusan, 602-741, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, 614-735, South Korea

Location

Hallym University sacred Heart Hospital

Pyungchon, 431-070, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 463-804, South Korea

Location

Yonsei University

Seoul, 120-752, South Korea

Location

Kyung Hee University Medical Center

Seoul, 130-702, South Korea

Location

Kyung Hee University East-West Nea Medical Center

Seoul, 134-090, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Yonsei University Youngdong Severance Hospital

Seoul, 135-723, South Korea

Location

Catholic University of Korea, kangnam St. Mary's Hospital

Seoul, 137-702, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, 137-708, South Korea

Location

Asan Medical Center

Seoul, 138-737, South Korea

Location

Korea University Anam Hospital

Seoul, 139-705, South Korea

Location

Eulji General Hospital

Seoul, 139-711, South Korea

Location

Catholic University of Korea, St. Mary's Hospital

Seoul, 150-713, South Korea

Location

Hallym University kangnam sacred Heart Hospital

Seoul, 150-951, South Korea

Location

Gachon University Gil Medical Center

Seoul, 405-222, South Korea

Location

Korea University Guro Hospital

Seoul, 82-2-818-6635, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

Wonju Christian Hospital

Wŏnju, 220-702, South Korea

Location

Related Publications (1)

• Kim JS, Park SM, Kim BK, Ko YG, Choi D, Hong MK, Seong IW, Kim BO, Gwon HC, Hong BK, Tahk SJ, Park SW, Kim CJ, Jeong MH, Yoon J, Jang Y; ECLAT-STEMI Trial investigators. Efficacy of clotinab in acute myocardial infarction trial-ST elevation myocardial infarction (ECLAT-STEMI). Circ J. 2012;76(2):405-13. doi: 10.1253/circj.cj-11-0676. Epub 2011 Dec 7.

  PMID: 22146757 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Yangsoo Jang, MD, Ph D

  Division of Cardiology, Cardiovascular Hospital, Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 11, 2009
• Study Start: July 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 4, 2010

Record last verified: 2009-02

Locations

KR (31)