Myocardial InfarctionPhase 4EASY-RESCUENCT00440895
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI and Rescue-PCI
A Phase 4 study testing Abciximab in people with Myocardial Infarction and Ischemia, run by Olivier F. Bertrand at 1 site in Canada.
Trial summary
Abciximab administration is safe and reduces ischemic complications in patients undergoing rescue PCI after failed thrombolysis compared to placebo. Abciximab improves angiographic scores and ventricular function after rescue-PCI compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Ischemia
- What is being tested?
- Abciximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2007to May 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with acute myocardial infarction eligible for rescue PCI within 24 hrs of symptoms.
- Failed thrombolysis (defined as less than 50% reduction of ST-elevation at 90 min ECG in the lead with previous maximal ST-segment elevation).
- Patient > 18 years old.
- 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 transradial/transulnar approach.
- The culprit lesion in a native coronary artery can identified and is suitable for immediate angioplasty and stent implantation.
Who cannot join
- Age > 75 years old
- Body weight < 65 kg
- Concurrent participation in other investigational study
- Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months
- Any significant blood dyscrasia, diathesis or INR > 2.0.
- Any clinical contraindication to abciximab administration i.e. known structural intracranial lesion, thrombocytopenia (< 100,000), hemoglobin level < 10 g/dl
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- Patient has received more than one dose of thrombolytic within 24 hours of symptoms
- Previous treatment with glycoproteins IIb-IIIa inhibitors within 30 days
- Perceived increased risk of intracranial or severe bleeding i.e. previous stroke/TIA, alteration of consciousness, recent trauma or major surgery.
- 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
- Evident cardiogenic shock
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 and RESCUE-PCI: The EASY-RESCUE Pilot Study
- Abciximab administration is safe and reduces ischemic complications in patients undergoing rescue PCI after failed thrombolysis compared to placebo.
- Abciximab improves angiographic scores and ventricular function after rescue-PCI compared to placebo.
- Intracoronary abciximab administration is more effective than intravenous route of administration in terms of acute and mid-term angiographic and clinical results.
- Intracoronary and intravenous bolus administration of abciximab dose provides similar platelet aggregation inhibition (PAI).
- There is a significant relationship between PAI after abciximab administration and indexes of myocardial perfusion.
- Routine use of Sirolimus-eluting stents (Cypher, Cordis, US) in rescue-PCI is associated with a low rate of target vessel revascularization.
- Cardiac MRI early and late after rescue-PCI provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores.
- After uncomplicated trans-radial rescue PCI, patients can be retransferred early to their referring center.
Read the detailed description
OBJECTIVES AND END-POINTS
The objectives of the present pilot study are to assess 1) the benefits and safety of abciximab i.c. or i.v. compared to placebo in rescue PCI and trans-radial approach, 2) the relationship between platelet aggregation inhibition and perfusion scores and to demonstrate 3) better perfusion scores with i.c. abciximab as compared to i.v. abciximab or placebo.
The Primary ANGIOGRAPHIC end-point will be the TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-months follow-up.
The Secondary CLINICAL end-point will be:
- the composite of death, stroke, repeat-myocardial infarction, urgent target vessel revascularization and major bleedings at 30 days after rescue PCI.
- composite of death, repeat-myocardial infarction, repeat target vessel revascularization at 6 months following rescue PCI.
The Secondary PLATELETS end-point will be the proportion of patients with platelet aggregation inhibition ≥ 95% and mean platelet aggregation inhibition 10 minutes post-bolus administration.
The Secondary ANGIOGRAPHIC end-points will be the angiographic late loss and the restenosis rate (Diameter stenosis ≥ 50%) in the culprit artery.
Other exploratory end-points include the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and PAI 6 hr after bolus administration.
- Conditions
- Myocardial Infarction, Ischemia
- Being tested
- Abciximab
- Keywords
- Coronary artery stenting, Trans-radial, Intracoronary, Rescue-PCI
- 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)
Abciximab (bolus) i.c. or i.v. or placebo, bolus dose is calculated according to current dosage (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).
| Study group | Role | What they receive |
|---|---|---|
| 1 intracoronary + infusion | Experimental | Bolus abciximab i.c. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min). Receives: Drug: Abciximab |
| 2 intravenous | Active comparator | Bolus abciximab i.v. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min). Receives: Drug: Abciximab |
| 3 Placebo | Placebo comparator | Bolus of placebo followed by 12 h infusion (placebo). Receives: Drug: Abciximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-month follow-up
Measured: 6 months
Secondary outcomes (5)
1 Composite of death, stroke, repeat-MI, urgent target vessel revascularization and major bleedings at 30 days after rescue PCI
Measured: 1 month
2 Composite of death, repeat-MI, repeat target vessel revascularization at 6 months following rescue PCI
Measured: 6 months
3 Proportion of patients with platelet aggregation inhibition ≥ 95% and mean platelet aggregation inhibition 10 min post-bolus administration
Measured: 10 min post PCI
4 Angiographic late loss and restenosis rate (diameter stenosis ≥ 50%) in the culprit artery
Measured: 6 months
5 Exploratory end-points include the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and PAI 6 h after bolus administration
Measured: 6-hr post PCI to hospital discharge
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 2012
- Study completionMay 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olivier F. Bertrand
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Cordis US Corp.
- Responsible party
- Sponsor-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
- NCT00440895
- Sponsor's protocol ID
- EASY-RESCUE
- Acronym
- EASY-RESCUE
- Status last verified
- May 2013
- First submitted
- 23 Feb 2007
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. 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 and RESCUE-PCI: The EASY-RESCUE Pilot Study
- ClinicalTrials.gov ID
- NCT00440895
- Acronym / sponsor ID
- EASY-RESCUE / EASY-RESCUE
- Conditions
- Myocardial Infarction, Ischemia
- Keywords
- Coronary artery stenting, Trans-radial, Intracoronary, Rescue-PCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Olivier F. BertrandUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Cordis US Corp.
- Study start
- Feb 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2013 (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.
- Abciximab administration is safe and reduces ischemic complications in patients undergoing rescue PCI after failed thrombolysis compared to placebo.
- Abciximab improves angiographic scores and ventricular function after rescue-PCI compared to placebo.
- Intracoronary abciximab administration is more effective than intravenous route of administration in terms of acute and mid-term angiographic and clinical results.
- Intracoronary and intravenous bolus administration of abciximab dose provides similar platelet aggregation inhibition (PAI).
- There is a significant relationship between PAI after abciximab administration and indexes of myocardial perfusion.
- Routine use of Sirolimus-eluting stents (Cypher, Cordis, US) in rescue-PCI is associated with a low rate of target vessel revascularization.
- Cardiac MRI early and late after rescue-PCI provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores.
- After uncomplicated trans-radial rescue PCI, patients can be retransferred early to their referring center.
Detailed description
OBJECTIVES AND END-POINTS
The objectives of the present pilot study are to assess 1) the benefits and safety of abciximab i.c. or i.v. compared to placebo in rescue PCI and trans-radial approach, 2) the relationship between platelet aggregation inhibition and perfusion scores and to demonstrate 3) better perfusion scores with i.c. abciximab as compared to i.v. abciximab or placebo.
The Primary ANGIOGRAPHIC end-point will be the TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-months follow-up.
The Secondary CLINICAL end-point will be:
- the composite of death, stroke, repeat-myocardial infarction, urgent target vessel revascularization and major bleedings at 30 days after rescue PCI.
- composite of death, repeat-myocardial infarction, repeat target vessel revascularization at 6 months following rescue PCI.
The Secondary PLATELETS end-point will be the proportion of patients with platelet aggregation inhibition ≥ 95% and mean platelet aggregation inhibition 10 minutes post-bolus administration.
The Secondary ANGIOGRAPHIC end-points will be the angiographic late loss and the restenosis rate (Diameter stenosis ≥ 50%) in the culprit artery.
Other exploratory end-points include the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and PAI 6 hr after bolus administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 intracoronary + infusion | Experimental | Drug: AbciximabBolus abciximab i.c. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min). |
| 2 intravenous | Active comparator | Drug: AbciximabBolus abciximab i.v. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min). |
| 3 Placebo | Placebo comparator | Drug: AbciximabBolus of placebo followed by 12 h infusion (placebo). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with acute myocardial infarction eligible for rescue PCI within 24 hrs of symptoms.
- Failed thrombolysis (defined as less than 50% reduction of ST-elevation at 90 min ECG in the lead with previous maximal ST-segment elevation).
- Patient > 18 years old.
- Patient and treating interventional cardiologist agree for randomization.
- Patient will be informed of the randomization process and will sign an informed consent.
Key exclusion criteria (12 listed)
- Age > 75 years old
- Body weight < 65 kg
- Concurrent participation in other investigational study
- Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 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)Abciximab (bolus) i.c. or i.v. or placebo, bolus dose is calculated according to current dosage (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min). | Drug | 1 intracoronary + infusion, 2 intravenous, 3 Placebo |
Primary outcome
TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-month follow-up
Time frame: 6 months
5 secondary outcomes
1 Composite of death, stroke, repeat-MI, urgent target vessel revascularization and major bleedings at 30 days after rescue PCI
Time frame: 1 month
2 Composite of death, repeat-MI, repeat target vessel revascularization at 6 months following rescue PCI
Time frame: 6 months
3 Proportion of patients with platelet aggregation inhibition ≥ 95% and mean platelet aggregation inhibition 10 min post-bolus administration
Time frame: 10 min post PCI
4 Angiographic late loss and restenosis rate (diameter stenosis ≥ 50%) in the culprit artery
Time frame: 6 months
5 Exploratory end-points include the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and PAI 6 h after bolus administration
Time frame: 6-hr post PCI to hospital discharge
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 8 May 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.
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 Olivier F. Bertrand 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 7 inclusion and 12 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 8 May 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 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. 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.
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?
TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-month follow-up (time frame: 6 months). 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 8 May 2013.