A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function

Not Applicable

• Conditions: Myocardial Infarction; Coronary Artery Disease
• Interventions: Drug: Abciximab

• Registration Number: NCT02105870
• Lead Sponsor: University of Melbourne

Brief Summary

Microvascular dysfunction is a key determinant of pathogenesis and outcome in patients suffering an acute myocardial infarction.

The investigators hypothesise that treatment with intracoronary abciximab, a potent anti platelet agent, at the time of coronary stent insertion, will improve microvascular function.

Detailed Description

The index of microcirculatory resistance (IMR), an invasive measure of coronary microvascular function, correlates with clinical outcomes in patients with stable angina and ST elevation myocardial infarction. The glycoprotein IIb/IIIa receptor inhibitor, abciximab, improves coronary microvascular function and reduces major cardiac adverse events in patients with acute coronary syndromes. This study will investigate whether an intracoronary bolus of abciximab in patients with non-ST elevation myocardial infarction decreases IMR and improves microvascular function.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-12-09
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-02
• Last Update Submitted: 2014-04-02
• Study First Posted: 2014-04-07
• Last Update Posted: 2014-04-07
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patient with acute coronary syndromes

Exclusion Criteria

• Patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent Patients with STEMI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracoronary abciximab (Reopro)	Abciximab	Intracoronary abciximab (Reopro)

Primary Outcome Measures

Name	Time	Method
Index of Microvascular Resistance	within 3 hours	We will assess IMR in the catheterisation laboratory immediately before PCI, then intracoronary reopro or placebo will be administered and we will re-assess IMR 15 minutes post delivery of the study drug. Finally we will perform PCI and immediately measure IMR post-procedure.

Secondary Outcome Measures

Name	Time	Method
Incidence of periprocedural myocardial infarction	within 24 hours	We will assess for periprocedural myocardial infarction 8 to 24 hours post PCI

Trial Locations

Locations (1)

St Vincent's Hospital; 🇦🇺 Fitzroy, Victoria, Australia