Efficacy of Early Administration of Clotinab in Acute Myocardial Infarction (ECLAT-STEMI)
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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 |
- MACCE (death, MI, TVR, cerebrovascular event) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and 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 | |
| Inje University Pusan Paik Hospital | |
| Pusan, Korea, Republic of, 614-735 | |
| Pusan National University Hospital | |
| Pusan, Korea, Republic of, 602-741 | |
| Hallym University sacred Heart Hospital | |
| Pyungchon, Korea, Republic of, 431-070 | |
| Seoul National University Bundang Hospital | |
| Seongnam, Korea, Republic of, 463-804 | |
| Gachon University Gil Medical Center | |
| Seoul, Korea, Republic of, 405-222 | |
| Korea University Anam Hospital | |
| Seoul, Korea, Republic of, 139-705 | |
| Kyung Hee University Medical Center | |
| Seoul, Korea, Republic of, 130-702 | |
| Yonsei University Youngdong Severance Hospital | |
| Seoul, Korea, Republic of, 135-723 | |
| Catholic University of Korea, St. Mary's Hospital | |
| Seoul, Korea, Republic of, 150-713 | |
| Yonsei University | |
| Seoul, Korea, Republic of, 120-752 | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-737 | |
| Eulji General Hospital | |
| Seoul, Korea, Republic of, 139-711 | |
| 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 | |
| Catholic University of Korea, kangnam St. Mary's Hospital | |
| Seoul, Korea, Republic of, 137-702 | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of, 135-710 | |
| Hallym University kangnam sacred Heart Hospital | |
| Seoul, Korea, Republic of, 150-951 | |
| Inje University Sanggye Paik Hospital | |
| Seoul, Korea, Republic of, 137-708 | |
| 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 | |
| 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 Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Abciximab Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Anticoagulants |
ClinicalTrials.gov processed this record on May 16, 2013