Myocardial InfarctionIntracorNCT02105870
A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
A study testing Abciximab in people with Myocardial Infarction and Coronary Artery Disease, run by University of Melbourne at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- Abciximab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with acute coronary syndromes
Who cannot join
- Patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent Patients with STEMI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
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.
Read the 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.
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Being tested
- Abciximab
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbciximabDrug
Also called Reopro
This drug will be administered intracoronary before percutaneous coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary abciximab (Reopro) | Experimental | Intracoronary abciximab (Reopro) Receives: Drug: Abciximab |
| Control group | Placebo comparator | Intracoronary Reopro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 3 hours
Secondary outcomes (1)
Incidence of periprocedural myocardial infarction
We will assess for periprocedural myocardial infarction 8 to 24 hours post PCI
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startFeb 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A/P Andrew Wilson, University of Melbourne
- Investigators
- Andrew Wilson, MD PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105870
- Sponsor's protocol ID
- SVH 001
- Acronym
- Intracor
- Status last verified
- Apr 2014
- First submitted
- 9 Dec 2013
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
- ClinicalTrials.gov ID
- NCT02105870
- Acronym / sponsor ID
- Intracor / SVH 001
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracoronary abciximab (Reopro) | Experimental | Drug: AbciximabIntracoronary abciximab (Reopro) |
| Control group | Placebo comparator | –Intracoronary Reopro |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with acute coronary syndromes
Key exclusion criteria (1 listed)
- Patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent Patients with STEMI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbciximabAlso: ReoproThis drug will be administered intracoronary before percutaneous coronary intervention. | Drug | Intracoronary abciximab (Reopro) |
Primary outcome
Index of Microvascular Resistance
Time frame: 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.
1 secondary outcome
Incidence of periprocedural myocardial infarction
Time frame: within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Wilson, MD PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abciximab in people with Myocardial Infarction and Coronary Artery Disease, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of Microvascular Resistance (time frame: within 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.