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

November 23, 2011 updated by: Olivier F. Bertrand, Laval University

A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute Myocardial Infarction: The EASY-MI Pilot Study.

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. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Laval Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gr 1 - intracoronary + infusion
abciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion
Drug: 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 Names:
  • Abciximab (ReoPro)
Experimental: Gr 2 - intracoronary
100% abciximab bolus dose 0.3 mg/kg ic
Drug: 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 Names:
  • Abciximab (ReoPro)
Active Comparator: Gr 3 - intravenous
abciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion
Drug: 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 Names:
  • Abciximab (ReoPro)
Experimental: Gr 4 - intravenous
100% abciximab bolus dose 0.3 mg/kg iv
Drug: 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 Names:
  • Abciximab (ReoPro)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with at least 95% platelet aggregation inhibition, and mean platelet aggregation inhibition.
Time Frame: 10 min after bolus of abciximab
10 min after bolus of abciximab

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite of death, stroke, repeat MI, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.
Time Frame: 30 days
30 days
Composite of cardiovascular death, repeat MI and repeat target vessel revascularization at 6-month follow-up.
Time Frame: 6 months
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
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
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
At 6hr post-PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Eli Lilly and Company
Cordis Corporation
Quebec Heart Institute

Investigators

  • Principal Investigator: Olivier F Bertrand, MD, PhD, Laval Hospital Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

November 24, 2011

Last Update Submitted That Met QC Criteria

November 23, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EASY-MI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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