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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02105870
Other study ID # SVH 001
Secondary ID
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


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
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