Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.

Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01080638
• Other study ID #: H-0906-046-283
• Status: Recruiting
• Phase: Phase 4
• First received: February 16, 2010
• Last updated: March 2, 2010
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Seoul National University Hospital
• Contact: Myung-Ki Seo, MD
• Phone: 82-2-2072-3757
• Email: clotinab[@]gmail.com
• Is FDA regulated: No
• Health authority: Republic of Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST elevation Myocardial infarction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• non-ST segment elevation acute myocardial infarction

• within 48 hours presence of chest pain

• Troponin-T or I positive before CAG

• First myocardial infarction

• will be performed coronary angioplasty

Exclusion Criteria:

• under 18 years of age,80 years or older

• Bleeding tendency

• History of major surgery within 4 weeks

• Major stroke within 2 years

• Thrombocytopenia (<120,000 / uL)

• Cardiogenic shock

• Known allergy to aspirin, heparin, or abciximab

• Contraindication of MRI at study entry (implanted pacemakers, defibrillators, intracranial metallic implants etc)

• Chronic atrial fibrillation

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty
• Infarction
• Myocardial Infarction

Intervention

Drug:
• glycoprotein IIb/IIIa inhibitor (abciximab)
patients intracoronary bolus only group and intravenous bolus and 12-hours continuous infusion group bolus:0.25mg/kg body weight,continus 12hrs-0.125ug/kg per minute(maximum: 10ug/min)

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In cardiac MRI- infarct size (total late enhancement volume at day 3-7)	MRI: magnetic resonance image	day 3~7 after percutaneous coronary intervention	No
Secondary	in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc.		1 month	No
Secondary	b. major bleeding : Hemoglobin 4 or more reduction, 2-unit If you need more than two RBC transfusions, intracranial or retroperitoneal bleeding, urgent operation for bleeding complication.	RBC: red blood cell	1 month	Yes
Secondary	TIMI III flow count /myocardial blush score after PCI	TIMI: thrombolysis in myocardial infarction PCI: percutaneous coronary intervention	1 day	No
Secondary	At cardiac MRI : LV ejection fraction,LV end-systolic volume,LV end diastolic volume,regional wall motion score index	LV: left ventricle	1 week	No
Secondary	Discharge, 1- month after comparing NT-proBNP	NT-proBNP : N-terminal pro-B-Type natriuretic peptide	1 month	No