Coronary versus Intravenous abCiximab administration during Emergency Reperfusion Of ST-segment elevation myocardial infarction – the CICERO trial - CICERO

Conditions: ST-segment elevation myocardial infarction (STEMI)

Registration Number: EUCTR2008-004485-12-NL

Lead Sponsor: niversity Medical Center of Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- a diagnosis of STEMI defined by
a. chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission
b. time from onset of symptoms of less than 12 hours
c. ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads
- primary PCI performed
- verbal followed by written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- rescue PCI after thrombolytic therapy
- need for emergency coronary artery bypass grafting
- presence of cardiogenic shock
- known existence of a life-threatening disease with a life expectancy of less than 6 months
- inability to provide informed consent
- age below 18 years
- contra-indications for the use of abciximab (active internal bleeding, history of stroke within 2 years, recent major surgery or intracranial or intraspinal trauma or surgery within 2 months, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensie or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether intracoronary bolus administration of abciximab during primary percutaneous coronary intervention is superior to intravenous bolus administration in improving myocardial perfusion in patients with STEMI. ;Secondary Objective: To assess the impact of abciximab on<br>- Bleeding complications<br>- Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow, myocardial blush grade and distal embolization on coronary angiography<br>-Persistent residual ST-segment deviation 30 to 60 minutes after the procedure<br>-Enzymatic infarct size<br>-Quantitative Coronary Angiographic measurements of vessel and lesion<br>-Mortality and Major Adverse Cardiac Events (MACE, a combined end point of target vessel revascularization, reinfarction, and cardiovascular mortality) at 30 days and 1 year.<br>;Primary end point(s): The primary end point is a 25% increase in the incidence of ST-segment resolution >70% in the group treated with IC administration of abciximab.

Secondary Outcome Measures