A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function

Coronary Artery Disease Clinical Trial

— Intracor  

Official title:

A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02105870
• Other study ID #: SVH 001
• Status: Active, not recruiting
• Phase: N/A
• First received: December 9, 2013
• Last updated: April 2, 2014
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2014
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• Abciximab
This drug will be administered intracoronary before percutaneous coronary intervention.

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Fitzroy	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index of Microvascular Resistance	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.	within 3 hours	No
Secondary	Incidence of periprocedural myocardial infarction	We will assess for periprocedural myocardial infarction 8 to 24 hours post PCI	within 24 hours	Yes