Myocardial InfarctionPhase 4EASY-MINCT00440778
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI
A Phase 4 study testing Abciximab in people with Myocardial Infarction and Ischemia, run by Laval University at 1 site in Canada.
Trial summary
HYPOTHESES 1. Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Ischemia
- What is being tested?
- Abciximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2007to Oct 2008
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with acute myocardial infarction eligible for primary PCI within 6 h of symptoms: patient must have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of ischemia not eliminated with nitrates and onset within 6 h of randomization, and one of the following:
- ST-segment elevation ≥ 2 mm in 2 or more contiguous precordial ECG leads (anterior infarction)
- ST-segment depression ≥ 2 mm in V1, V2 or V2, V3 with reciprocal 1 mm ST-elevation in II, augmented unipolar foot (left leg) lead (AVF), and V6 (true posterior infarction)
- ST-segment elevation ≥ 1 mm in 2 or more contiguous limb ECG leads (other infarction)
- New or presumably new left bundle branch block (LBBB)
- Patient must be > 18 years of age.
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- Patient and treating interventional cardiologist agree for randomization.
- Patient will be informed of the randomization process and will sign an informed consent.
- Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.
- The culprit lesion can be identified on a native coronary vessel, which is suitable for primary PCI with stent implantation.
Who cannot join
- Patient has received thrombolytic therapy (within the last 4 weeks) and is referred for rescue PCI
- Concurrent participation in other investigational study
- Femoral sheath (artery)
- Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for at least 12 months
- Any significant blood dyscrasia, diathesis or INR > 2.0
- Any clinical contraindication to abciximab (ReoPro®) administration i.e. known structural intracranial lesion, thrombocytopenia < 100,000, active or recent bleeding or hemoglobin level known < 10 g/dl.
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- Any glycoprotein IIb-IIIa inhibitors use in the previous 30 days
- Uncontrolled high blood pressure i.e. systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
- Life expectancy less than 6 months owing to non-cardiac cause
- Infarction caused by in-stent thrombosis or restenosis
- Cardiogenic shock evident before randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute Myocardial Infarction: The EASY-MI Pilot Study.
HYPOTHESES
- Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration.
- Total dose of abciximab can be given as a single bolus and is more effective than bolus (0.25 mg/kg) + 12 hrs infusion in terms of acute and mid-term angiographic and clinical results.
- Intracoronary (ic) abciximab administration is more effective than intravenous (iv) route of administration in terms of acute and mid-term angiographic and clinical results.
- There is a relationship between PAI and angiographic perfusion scores.
- Routine use of sirolimus-eluting stents (Cypher, Cordis) in primary-PCI is associated with a low rate of target vessel revascularization and complications.
- Cardiac MRI early and late after primary-PCI provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores.
- After uncomplicated trans-radial PCI, patients can be retransferred early to their referring center.
Read the detailed description
OBJECTIVES AND END-POINTS The objectives of the present study are to assess the benefits and safety of 1) a single bolus of abciximab (100% dose) compared with the standard bolus (ca 80% of the total dose) + 12h infusion (ca 20% of the total dose), and 2) intracoronary abciximab bolus administration compared with intravenous route of abciximab administration in primary PCI.
The primary PLATELETS end-points are the percentage of patients with ≥ 95% platelet aggregation inhibition 10 minutes after abciximab bolus (MAX) and the mean platelet aggregation inhibition 10 minutes after abciximab bolus (MEAN).
The secondary CLINICAL end-points of the study are:
- The composite of death, stroke, repeat myocardial infarction, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.
- The composite of cardiovascular death, repeat myocardial infarction and repeat target vessel revascularization at 6-months follow-up.
The secondary ANGIOGRAPHIC end-points of the study are:
- The proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel.
- The restenosis rate (diameter stenosis ≥ 50%) and late loss in the culprit vessel at 6-months follow-up.
Other exploratory end-points are the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, the cardiac MRI measurements and platelet aggregation inhibition at 6h post-PCI.
- Conditions
- Myocardial Infarction, Ischemia
- Being tested
- Abciximab
- Keywords
- Coronary artery stenting, Trans-radial, Intracoronary
- Medical subject headings
- Myocardial Infarction, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbciximabDrug
Also called Abciximab (ReoPro)
100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion
| Study group | Role | What they receive |
|---|---|---|
| Gr 1 - intracoronary + infusion | Experimental | abciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion Receives: Drug: Abciximab |
| Gr 2 - intracoronary | Experimental | 100% abciximab bolus dose 0.3 mg/kg ic Receives: Drug: Abciximab |
| Gr 3 - intravenous | Active comparator | abciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion Receives: Drug: Abciximab |
| Gr 4 - intravenous | Experimental | 100% abciximab bolus dose 0.3 mg/kg iv Receives: Drug: Abciximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at least 95% platelet aggregation inhibition, and mean platelet aggregation inhibition.
Measured: 10 min after bolus of abciximab
Secondary outcomes (5)
Composite of death, stroke, repeat MI, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.
Measured: 30 days
Composite of cardiovascular death, repeat MI and repeat target vessel revascularization at 6-month follow-up.
Measured: 6 months
Proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel.
Measured: At end of PCI
Restenosis rate (diameter stenosis equal or higher than 50%) and late loss in the culprit vessel at 6-month follow-up.
Measured: 6 months
Exploratory end-points: feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and platelet aggregation inhibition at 6hr post-PCI.
Measured: At 6hr post-PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Cordis US Corp., Quebec Heart Institute
- Responsible party
- Principal investigator, Olivier F. Bertrand, Laval University
- Investigators
- Olivier F Bertrand, MD, PhD, Principal investigator, Laval Hospital Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440778
- Sponsor's protocol ID
- EASY-MI
- Acronym
- EASY-MI
- Status last verified
- Nov 2011
- First submitted
- 23 Feb 2007
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bertrand OF, Larose E, Costerousse O, Mongrain R, Rodes-Cabau J, Dery JP, Nguyen CM, Barbeau G, Gleeton O, Proulx G, De Larochelliere R, Noel B, Roy L. Effects of aspiration thrombectomy on necrosis size and ejection fraction after transradial percutaneous coronary intervention in acute ST-elevation myocardial infarction. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):475-82. doi: 10.1002/ccd.22692.
PubMed 20578162
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute Myocardial Infarction: The EASY-MI Pilot Study.
- ClinicalTrials.gov ID
- NCT00440778
- Acronym / sponsor ID
- EASY-MI / EASY-MI
- Conditions
- Myocardial Infarction, Ischemia
- Keywords
- Coronary artery stenting, Trans-radial, Intracoronary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Cordis US Corp., Quebec Heart Institute
- Study start
- Feb 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 27 Feb 2007 (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.
HYPOTHESES
- Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration.
- Total dose of abciximab can be given as a single bolus and is more effective than bolus (0.25 mg/kg) + 12 hrs infusion in terms of acute and mid-term angiographic and clinical results.
- Intracoronary (ic) abciximab administration is more effective than intravenous (iv) route of administration in terms of acute and mid-term angiographic and clinical results.
- There is a relationship between PAI and angiographic perfusion scores.
- Routine use of sirolimus-eluting stents (Cypher, Cordis) in primary-PCI is associated with a low rate of target vessel revascularization and complications.
- Cardiac MRI early and late after primary-PCI provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores.
- After uncomplicated trans-radial PCI, patients can be retransferred early to their referring center.
Detailed description
OBJECTIVES AND END-POINTS The objectives of the present study are to assess the benefits and safety of 1) a single bolus of abciximab (100% dose) compared with the standard bolus (ca 80% of the total dose) + 12h infusion (ca 20% of the total dose), and 2) intracoronary abciximab bolus administration compared with intravenous route of abciximab administration in primary PCI.
The primary PLATELETS end-points are the percentage of patients with ≥ 95% platelet aggregation inhibition 10 minutes after abciximab bolus (MAX) and the mean platelet aggregation inhibition 10 minutes after abciximab bolus (MEAN).
The secondary CLINICAL end-points of the study are:
- The composite of death, stroke, repeat myocardial infarction, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.
- The composite of cardiovascular death, repeat myocardial infarction and repeat target vessel revascularization at 6-months follow-up.
The secondary ANGIOGRAPHIC end-points of the study are:
- The proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel.
- The restenosis rate (diameter stenosis ≥ 50%) and late loss in the culprit vessel at 6-months follow-up.
Other exploratory end-points are the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, the cardiac MRI measurements and platelet aggregation inhibition at 6h post-PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gr 1 - intracoronary + infusion | Experimental | Drug: Abciximababciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion |
| Gr 2 - intracoronary | Experimental | Drug: Abciximab100% abciximab bolus dose 0.3 mg/kg ic |
| Gr 3 - intravenous | Active comparator | Drug: Abciximababciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion |
| Gr 4 - intravenous | Experimental | Drug: Abciximab100% abciximab bolus dose 0.3 mg/kg iv |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient with acute myocardial infarction eligible for primary PCI within 6 h of symptoms: patient must have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of ischemia not eliminated with nitrates and onset within 6 h of randomization, and one of the following:
- Patient must be > 18 years of age.
- Patient and treating interventional cardiologist agree for randomization.
- Patient will be informed of the randomization process and will sign an informed consent.
- Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.
Key exclusion criteria (11 listed)
- Patient has received thrombolytic therapy (within the last 4 weeks) and is referred for rescue PCI
- Concurrent participation in other investigational study
- Femoral sheath (artery)
- Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for at least 12 months
- Any significant blood dyscrasia, diathesis or INR > 2.0
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: Abciximab (ReoPro)100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion | Drug | Gr 1 - intracoronary + infusion, Gr 2 - intracoronary, Gr 3 - intravenous, Gr 4 - intravenous |
Primary outcome
Percentage of patients with at least 95% platelet aggregation inhibition, and mean platelet aggregation inhibition.
Time frame: 10 min after bolus of abciximab
5 secondary outcomes
Composite of death, stroke, repeat MI, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.
Time frame: 30 days
Composite of cardiovascular death, repeat MI and repeat target vessel revascularization at 6-month follow-up.
Time frame: 6 months
Proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel.
Time frame: At end of PCI
Restenosis rate (diameter stenosis equal or higher than 50%) and late loss in the culprit vessel at 6-month follow-up.
Time frame: 6 months
Exploratory end-points: feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and platelet aggregation inhibition at 6hr post-PCI.
Time frame: At 6hr post-PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
- Derived from this study: PubMed 20578162Bertrand OF, Larose E, Costerousse O, Mongrain R, Rodes-Cabau J, Dery JP, Nguyen CM, Barbeau G, Gleeton O, Proulx G, De Larochelliere R, Noel B, Roy L. Effects of aspiration thrombectomy on necrosis size and ejection fraction after transradial percutaneous coronary intervention in acute ST-elevation myocardial infarction. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):475-82. doi: 10.1002/ccd.22692.
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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.
Olivier F Bertrand, MD, PhD principal investigator
Laval Hospital Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abciximab in people with Myocardial Infarction and Ischemia, run by Laval University at 1 site in Canada.
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 10 inclusion and 11 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: finished, as of the sponsor's last update on 24 Nov 2011. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients with at least 95% platelet aggregation inhibition, and mean platelet aggregation inhibition. (time frame: 10 min after bolus of abciximab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00440778, which also lists 1 linked publication.
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 Nov 2011.