A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI
NCT ID: NCT00440778
Last Updated: 2011-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
105 participants
INTERVENTIONAL
2007-02-28
2008-10-31
Brief Summary
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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. 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.
3. Intracoronary (ic) abciximab administration is more effective than intravenous (iv) route of administration in terms of acute and mid-term angiographic and clinical results.
4. There is a relationship between PAI and angiographic perfusion scores.
5. Routine use of sirolimus-eluting stents (Cypher, Cordis) in primary-PCI is associated with a low rate of target vessel revascularization and complications.
6. Cardiac MRI early and late after primary-PCI provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores.
7. After uncomplicated trans-radial PCI, patients can be retransferred early to their referring center.
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Gr 1 - intracoronary + infusion
abciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion
Abciximab
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
Gr 2 - intracoronary
100% abciximab bolus dose 0.3 mg/kg ic
Abciximab
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
Gr 3 - intravenous
abciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion
Abciximab
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
Gr 4 - intravenous
100% abciximab bolus dose 0.3 mg/kg iv
Abciximab
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
Interventions
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Abciximab
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Cordis Corporation
INDUSTRY
Quebec Heart Institute
OTHER
Laval University
OTHER
Responsible Party
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Olivier F. Bertrand
MD, PhD
Principal Investigators
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Olivier F Bertrand, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Laval Hospital Research Center
Locations
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Laval Hospital
Québec, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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EASY-MI
Identifier Type: -
Identifier Source: org_study_id