Overview

This trial is active, not recruiting.

Condition st-elevation myocardial infarction
Treatments abciximab
Sponsor University Medical Centre Groningen
Start date September 2008
End date May 2010
Trial size 534 participants
Trial identifier NCT00927615, 200807

Summary

The primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
intracoronary administration of abciximab (0.25 mg/kg body weight)
abciximab ReoPro
0.25 mg/kg body weight (intracoronary)
(Active Comparator)
intravenous administration of abciximab (0.25 mg/kg body weight)
abciximab ReoPro
0.25 mg/kg body weight (intravenous)

Primary Outcomes

Measure
incidence of ST-segment resolution >70%
time frame: 30 to 60 minutes post-PCI

Secondary Outcomes

Measure
Bleeding complications
time frame: in-hospital
Thrombolysis In Myocardial Infarction (TIMI) flow
time frame: post-PCI
Myocardial Blush Grade (MBG)
time frame: post-PCI
Incidence of distal embolization
time frame: post-PCI
persistent residual ST-segment deviation
time frame: 30 to 60 minutes post-PCI
enzymatic infarct size
time frame: in-hospital
Major Adverse Cardiac Events (MACE)
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: a diagnosis of STEMI defined by - chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission - time from onset of symptoms of less than 12 hours - ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads 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 - 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, hypertensive or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins)

Additional Information

Official title Coronary Versus Intravenous abCiximab Administration During Emergency Reperfusion Of ST-segment Elevation Myocardial Infarction - the CICERO Trial
Principal investigator Felix Zijlstra, MD PhD
Description The contemporary management of ST-segment elevation myocardial infarction (STEMI) consists of primary percutaneous coronary intervention (PCI) including thrombus aspiration and stenting. There is, however, still a high incidence of impaired post-procedural myocardial perfusion, which is associated with poorer clinical outcomes. Intravenous (IV) administration of the glycoprotein IIb/IIIa inhibitor abciximab during primary PCI plays an important role in the treatment of patients with STEMI. With higher local drug concentrations, abciximab may have additional anti-platelet, anti-thrombotic and anti-inflammatory features. These possible benefits may be obtained by intracoronary (IC) administration of abciximab. Recent small- to medium-scaled studies have suggested that IC administration of abciximab instead of the (IV) route is associated with improved post-procedural myocardial perfusion and a clinically relevant reduction of major adverse cardiac events. Because of the limited number of patients included in these studies, a larger randomized clinical trial is needed to evaluate the effect of IC abciximab in patients with STEMI. Furthermore, the combined strategy of PCI with thrombus aspiration and IC use of abciximab has not been investigated. Therefore, the investigators intend to evaluate the effect of IC bolus administration of abciximab compared to IV bolus administration on post-procedural myocardial perfusion as assessed by the extent of ST-segment elevation resolution in patients with STEMI undergoing primary PCI. The study is a single-center, prospective, randomized trial with blinded evaluation of endpoints.
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by University Medical Centre Groningen.