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A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI (EASY-MI)

Primary Purpose

Myocardial Infarction, Ischemia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Abciximab
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Coronary artery stenting, Trans-radial, Intracoronary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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:

  • 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.
  • 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

Sites / Locations

  • Laval Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Gr 1 - intracoronary + infusion

Gr 2 - intracoronary

Gr 3 - intravenous

Gr 4 - intravenous

Arm Description

abciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion

100% abciximab bolus dose 0.3 mg/kg ic

abciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion

100% abciximab bolus dose 0.3 mg/kg iv

Outcomes

Primary Outcome Measures

Percentage of patients with at least 95% platelet aggregation inhibition, and mean platelet aggregation inhibition.

Secondary Outcome Measures

Composite of death, stroke, repeat MI, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.
Composite of cardiovascular death, repeat MI and repeat target vessel revascularization at 6-month follow-up.
Proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel.
Restenosis rate (diameter stenosis equal or higher than 50%) and late loss in the culprit vessel at 6-month follow-up.
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.

Full Information

First Posted
February 23, 2007
Last Updated
November 23, 2011
Sponsor
Laval University
Collaborators
Eli Lilly and Company, Cordis Corporation, Quebec Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00440778
Brief Title
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI
Acronym
EASY-MI
Official Title
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute Myocardial Infarction: The EASY-MI Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Eli Lilly and Company, Cordis Corporation, Quebec Heart Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Ischemia
Keywords
Coronary artery stenting, Trans-radial, Intracoronary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gr 1 - intracoronary + infusion
Arm Type
Experimental
Arm Description
abciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion
Arm Title
Gr 2 - intracoronary
Arm Type
Experimental
Arm Description
100% abciximab bolus dose 0.3 mg/kg ic
Arm Title
Gr 3 - intravenous
Arm Type
Active Comparator
Arm Description
abciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion
Arm Title
Gr 4 - intravenous
Arm Type
Experimental
Arm Description
100% abciximab bolus dose 0.3 mg/kg iv
Intervention Type
Drug
Intervention Name(s)
Abciximab
Other Intervention Name(s)
Abciximab (ReoPro)
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of patients with at least 95% platelet aggregation inhibition, and mean platelet aggregation inhibition.
Time Frame
10 min after bolus of abciximab
Secondary Outcome Measure Information:
Title
Composite of death, stroke, repeat MI, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.
Time Frame
30 days
Title
Composite of cardiovascular death, repeat MI and repeat target vessel revascularization at 6-month follow-up.
Time Frame
6 months
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier F Bertrand, MD, PhD
Organizational Affiliation
Laval Hospital Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval Hospital
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20578162
Citation
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.
Results Reference
derived

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A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI

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