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Efficacy of Early Administration of Clotinab in Acute Myocardial Infarction (ECLAT-STEMI)

This study has been completed.
Sponsor:
Collaborator:
ISU ABXIS (Korea pharmaceutical company)
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00841438
First received: February 10, 2009
Last updated: May 3, 2010
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: Clotinab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Clotinab in Acute Myocardial Infarction Trial- ST Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • MACCE (death, MI, TVR, cerebrovascular event) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MACCE (death, MI, TVR, cerebrovascular event) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • TIMI flow at before and after PCI [ Time Frame: Immediate post procedure ] [ Designated as safety issue: No ]
  • Corrected TIMI frame count after PCI [ Time Frame: Immediate postprocedure ] [ Designated as safety issue: No ]

Enrollment: 786
Study Start Date: July 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Provisional use of Clotinab
Provisional use of clotinab
Drug: Clotinab
Clotinab: IV bolus 0.25 mg per Kg and a 12-hour IV infusion 0.125 μg per kg
Other Name: Clotinab, Gp IIb/IIIa inhibitor
Experimental: Upstream use of clotinab
early upstream use of clotinab
Drug: Clotinab
Clotinab: IV bolus 0.25 mg per Kg and a 12-hour IV infusion 0.125 μg per kg
Other Name: Clotinab, Gp IIb/IIIa inhibitor

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841438

Locations
Korea, Republic of
Dankook University Hospital
Cheonan, Korea, Republic of, 330-716
Chonbuk National University Hospital
Cheonju, Korea, Republic of, 561-716
Yeungnam University Hospital
Daegu, Korea, Republic of, 705-717
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 700-712
Chungnam National University Hospital
Daejeon, Korea, Republic of, 301-721
Dongguk University International Hospital
Goyang, Korea, Republic of, 410-773
Myongji Hospital
Goyang, Korea, Republic of, 412-270
National Health Insurance Corporation Ilsan Hospital
Goyang, Korea, Republic of, 410-719
Chonnam National University Hospital
Gwangju, Korea, Republic of, 501-759
Pusan National University Hospital
Pusan, Korea, Republic of, 602-741
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of, 614-735
Hallym University sacred Heart Hospital
Pyungchon, Korea, Republic of, 431-070
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-804
Catholic University of Korea, St. Mary's Hospital
Seoul, Korea, Republic of, 150-713
Catholic University of Korea, kangnam St. Mary's Hospital
Seoul, Korea, Republic of, 137-702
Yonsei University Youngdong Severance Hospital
Seoul, Korea, Republic of, 135-723
Eulji General Hospital
Seoul, Korea, Republic of, 139-711
Gachon University Gil Medical Center
Seoul, Korea, Republic of, 405-222
Asan Medical Center
Seoul, Korea, Republic of, 138-737
Inje University Sanggye Paik Hospital
Seoul, Korea, Republic of, 137-708
Korea University Anam Hospital
Seoul, Korea, Republic of, 139-705
Korea University Guro Hospital
Seoul, Korea, Republic of, 82-2-818-6635
Kyung Hee University East-West Nea Medical Center
Seoul, Korea, Republic of, 134-090
Kyung Hee University Medical Center
Seoul, Korea, Republic of, 130-702
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Yonsei University
Seoul, Korea, Republic of, 120-752
Hallym University kangnam sacred Heart Hospital
Seoul, Korea, Republic of, 150-951
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
Wonju Christian Hospital
Wonju, Korea, Republic of, 220-702
Sponsors and Collaborators
Yonsei University
ISU ABXIS (Korea pharmaceutical company)
Investigators
Principal Investigator: Yangsoo Jang, MD, Ph D Division of Cardiology, Cardiovascular Hospital, Yonsei University
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yangsoo Jang, Severance hospital, Yonsei university
ClinicalTrials.gov Identifier: NCT00841438     History of Changes
Other Study ID Numbers: ISU-CLT-07001
Study First Received: February 10, 2009
Last Updated: May 3, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
Angioplasty
Transluminal
Percutaneous Coronary

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Abciximab
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014