Acute Myocardial InfarctionPhase 2ICENCT00945308
Effectiveness of Intracoronary Injection of Eptifibatide in Primary Coronary Intervention in STEMI Patients
A Phase 2 study testing Eptifibatide in people with Acute Myocardial Infarction, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The achievement of high local concentration of Eptifibatide, a GP 2b3a inhibitor,via direct intracoronary injection, promotes (in vitro) clot disaggregation. It remains unclear if it is of superior benefit than the routine intravenous administration of these agents. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Eptifibatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Feb 2010
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial infarction candidate for primary coronary angioplasty, presenting within 12 hours of onset of pain and ability to clearly identified only one infarct related artery.
Who cannot join
- Contraindications for antiplatelet therapy such as bleeding disorders,
- Thrombocytopenia,
- Severe uncontrolled hypertension,
- Recent stroke (<6 months),
- Intracranial hemorrhage at any time
- Patients after recent major surgery (<30 days),
- Previous myocardial infarction
- Previous revascularization either by CABG or PCI and 9)patients presented with cardiogenic shock.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf Harofeh Medical Center
Beer Yakov, Beer Yakov, 70300
Alberto Hendler, MD, +9726467757, ahendler@asaf.health.gov.il
Alberto Hendler, MD
About this study
Official title: Effectiveness of Intracoronary Injection of Eptifibatide as Adjunctive Antiplatelet Therapy in Primary Coronary Intervention in Patients With ST Segment Elevation Acute Myocardial Infarction.
The achievement of high local concentration of Eptifibatide, a GP 2b3a inhibitor,via direct intracoronary injection, promotes (in vitro) clot disaggregation. It remains unclear if it is of superior benefit than the routine intravenous administration of these agents.
In patients presenting with acute myocardial infarction, and undergoing primary coronary intervention, intracoronary administration of Eptifibatide may increase local drug concentration by several orders of magnitude and promote clot disaggregation with a minimal increase in systemic drug concentration, and in that way enhancing myocardial perfusion and survival.
Read the detailed description
Patients will be randomized, prospectively, single blinded into one of two arms:1)intravenous administration of Eptifibatide and 2) intracoronary administration. The primary end-point will be the angiographic achievement of TIMI 3 flow at the infarct related artery and TIMI myocardial perfusion grade (blush) and the electrocardiographic surrogate of myocardial perfusion the ST segment resolution.
The secondary end-points will be the occurrence of bleeding or hemorrhagic complication according to TIMI classification and the LVEF at one month compared with baseline
- Conditions
- Acute Myocardial Infarction
- Being tested
- Eptifibatide
- Keywords
- Primary PCI, Acute myocardial infarction, Myocardial blush, Primary coronary intervention in acute myocardial infarction, focusing on the effect of the study drug on the immediate TIMI, flow at the infarct related artery and on the myocardial, perfusion evaluated by the TIMI myocardial perfusion grade or, blush
- Medical subject headings
- Blushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EptifibatideDrug
Intracoronary injection of Eptifibatide injected in two consecutive bolus of 180 mcg/kg each, followed immediately by continuous infusion of 2 mcg/kg/min for 12 hs.
EptifibatideDrug
Intravenous injection of Eptifibatide in two consecutive boluses of 180 mcg/kg followed by continuous intravenous injection dosing 2 mcg/kg/min for 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Eptifibatide (intracoronary) | Active comparator | Not described Receives: Drug: Eptifibatide |
| Eptifibatide (intravenous) | Active comparator | Not described Receives: Drug: Eptifibatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary angiography
Measured: At the time of the procedure
Secondary outcomes (1)
Electrocardiogram
Measured: 90 min after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945308
- Sponsor's protocol ID
- 97/09
- Acronym
- ICE
- Status last verified
- Jul 2009
- First submitted
- 8 Jul 2009
- Last updated
- 24 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intracoronary Injection of Eptifibatide as Adjunctive Antiplatelet Therapy in Primary Coronary Intervention in Patients With ST Segment Elevation Acute Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT00945308
- Acronym / sponsor ID
- ICE / 97/09
- Conditions
- Acute Myocardial Infarction
- Keywords
- Primary PCI, Acute myocardial infarction, Myocardial blush, Primary coronary intervention in acute myocardial infarction, focusing on the effect of the study drug on the immediate TIMI, flow at the infarct related artery and on the myocardial, perfusion evaluated by the TIMI myocardial perfusion grade or, blush
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Aug 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 24 Jul 2009 (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.
The achievement of high local concentration of Eptifibatide, a GP 2b3a inhibitor,via direct intracoronary injection, promotes (in vitro) clot disaggregation. It remains unclear if it is of superior benefit than the routine intravenous administration of these agents.
In patients presenting with acute myocardial infarction, and undergoing primary coronary intervention, intracoronary administration of Eptifibatide may increase local drug concentration by several orders of magnitude and promote clot disaggregation with a minimal increase in systemic drug concentration, and in that way enhancing myocardial perfusion and survival.
Detailed description
Patients will be randomized, prospectively, single blinded into one of two arms:1)intravenous administration of Eptifibatide and 2) intracoronary administration. The primary end-point will be the angiographic achievement of TIMI 3 flow at the infarct related artery and TIMI myocardial perfusion grade (blush) and the electrocardiographic surrogate of myocardial perfusion the ST segment resolution.
The secondary end-points will be the occurrence of bleeding or hemorrhagic complication according to TIMI classification and the LVEF at one month compared with baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eptifibatide (intracoronary) | Active comparator | Drug: Eptifibatide |
| Eptifibatide (intravenous) | Active comparator | Drug: Eptifibatide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute myocardial infarction candidate for primary coronary angioplasty, presenting within 12 hours of onset of pain and ability to clearly identified only one infarct related artery.
Key exclusion criteria (8 listed)
- Contraindications for antiplatelet therapy such as bleeding disorders,
- Thrombocytopenia,
- Severe uncontrolled hypertension,
- Recent stroke (<6 months),
- Intracranial hemorrhage at any time
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 |
|---|---|---|
| EptifibatideIntracoronary injection of Eptifibatide injected in two consecutive bolus of 180 mcg/kg each, followed immediately by continuous infusion of 2 mcg/kg/min for 12 hs. | Drug | Eptifibatide (intracoronary) |
| EptifibatideIntravenous injection of Eptifibatide in two consecutive boluses of 180 mcg/kg followed by continuous intravenous injection dosing 2 mcg/kg/min for 12 hours | Drug | Eptifibatide (intravenous) |
Primary outcome
Coronary angiography
Time frame: At the time of the procedure
1 secondary outcome
Electrocardiogram
Time frame: 90 min after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2009.
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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 Phase 2 study testing Eptifibatide in people with Acute Myocardial Infarction, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 8 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 24 Jul 2009. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alberto Hendler, MD (+972526467757, ahendler@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary angiography (time frame: At the time of the procedure). 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 24 Jul 2009.