A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function

NCT ID: NCT02105870

Last Updated: 2014-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intracoronary abciximab (Reopro)

Intracoronary abciximab (Reopro)

Group Type EXPERIMENTAL

Abciximab

Intervention Type DRUG

This drug will be administered intracoronary before percutaneous coronary intervention.

Control group

Intracoronary Reopro

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Abciximab

This drug will be administered intracoronary before percutaneous coronary intervention.

Intervention Type DRUG

Other Intervention Names

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Reopro

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

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A/P Andrew Wilson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Wilson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Locations

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St Vincent's Hospital

Fitzroy, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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SVH 001

Identifier Type: -

Identifier Source: org_study_id

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