Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic TherapyNCT01971788
The MATRIX OCT Substudy
A study testing Optical Coherence Tomography of the infarct related artery in people with Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy, run by S.M. Misericordia Hospital at 1 site in Italy.
Trial summary
Residual thrombosis of stent struts may occur after the end of primary angioplasty and determine distal embolization and further myocardial damage. Bivalirudin is considered the most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase in stent thrombosis has been reported. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy
- What is being tested?
- Optical Coherence Tomography of the infarct related artery
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study showing the following features:
- patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
- patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
- patients with a coronary anatomy suitable for OCT evaluation.
Who cannot join
- The same criteria used in MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Misericordia Hospital
Grosseto, Italy, 58100
Ugo Limbruno, MD,PhD, FESC, +390564483465, ulimbru@tin.it
Andrea Picchi, MD, PhD, +3905644834645, andre.picchi@gmail.com
About this study
Residual thrombosis of stent struts may occur after the end of primary angioplasty and determine distal embolization and further myocardial damage. Bivalirudin is considered the most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase in stent thrombosis has been reported. In order to overcome this potential adverse event, a prolonged infusion of bivalirudin after the end of PCI has been proposed.
This aim of this study is to test whether the use of long-term bivalirudin infusion, as compared to the intra-procedural only administration, reduces residual thrombosis of stent struts evaluated by optical coherence tomography (OCT) at the end of primary PCI and at 3-5 days follow-up.
Read more
A subgroup of patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study will be selected showing the following inclusion criteria:
- patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
- patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
- patients whose anatomy is suitable for OCT evaluation.
- Being tested
- Optical Coherence Tomography of the infarct related artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography of the infarct related arteryDevice
| Study group | Role | What they receive |
|---|---|---|
| Prolonged bivalirudin infusion | Experimental | Bivalirudin infusion is prolonged after the end of primary PCI Receives: Device: Optical Coherence Tomography of the infarct related artery |
| Intra-procedural bivalirudin infusion | Active comparator | Bivalirudin infusion is stopped at the end of primary PCI Receives: Device: Optical Coherence Tomography of the infarct related artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Minimal Flow Area (MinFA) measured at the end of primary PCI and at 4/5-day follow-up
Measured: At the end of primary PCI and 4-5 day later
Secondary outcomes (1)
Change in the number of stent cross sections with a thrombotic area > 10% measured at the end of prymary PCI and at 4/5-day follow-up
Measured: Athe end of primary PCI and 4/5 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic TherapyStudies 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
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.M. Misericordia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Picchi, S.M. Misericordia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971788
- Sponsor's protocol ID
- MATRIXOCT2013
- Status last verified
- Oct 2013
- First submitted
- 18 Oct 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MATRIX OCT Substudy
- ClinicalTrials.gov ID
- NCT01971788
- Acronym / sponsor ID
- MATRIXOCT2013
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- S.M. Misericordia HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 29 Oct 2013 (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.
Residual thrombosis of stent struts may occur after the end of primary angioplasty and determine distal embolization and further myocardial damage. Bivalirudin is considered the most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase in stent thrombosis has been reported. In order to overcome this potential adverse event, a prolonged infusion of bivalirudin after the end of PCI has been proposed.
This aim of this study is to test whether the use of long-term bivalirudin infusion, as compared to the intra-procedural only administration, reduces residual thrombosis of stent struts evaluated by optical coherence tomography (OCT) at the end of primary PCI and at 3-5 days follow-up.
A subgroup of patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study will be selected showing the following inclusion criteria:
- patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
- patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
- patients whose anatomy is suitable for OCT evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged bivalirudin infusion | Experimental | Device: Optical Coherence Tomography of the infarct related arteryBivalirudin infusion is prolonged after the end of primary PCI |
| Intra-procedural bivalirudin infusion | Active comparator | Device: Optical Coherence Tomography of the infarct related arteryBivalirudin infusion is stopped at the end of primary PCI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study showing the following features:
Key exclusion criteria (1 listed)
- The same criteria used in MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study.
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 |
|---|---|---|
| Optical Coherence Tomography of the infarct related artery | Device | Intra-procedural bivalirudin infusion, Prolonged bivalirudin infusion |
Primary outcome
Change in Minimal Flow Area (MinFA) measured at the end of primary PCI and at 4/5-day follow-up
Time frame: At the end of primary PCI and 4-5 day later
1 secondary outcome
Change in the number of stent cross sections with a thrombotic area > 10% measured at the end of prymary PCI and at 4/5-day follow-up
Time frame: Athe end of primary PCI and 4/5 days later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography of the infarct related artery in people with Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy, run by S.M. Misericordia Hospital at 1 site in Italy.
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 4 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 29 Oct 2013. 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 Italy. 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. 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?
Contact Ugo Limbruno, MD, PhD, FESC (+390564483465, ulimbru@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Minimal Flow Area (MinFA) measured at the end of primary PCI and at 4/5-day follow-up (time frame: At the end of primary PCI and 4-5 day later). 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 29 Oct 2013.