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

Primary Purpose

Myocardial Infarction, Ischemia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Abciximab
Sponsored by
Olivier F. Bertrand
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, Rescue-PCI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Laval Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1 intracoronary + infusion

2 intravenous

3 Placebo

Arm Description

Bolus abciximab i.c. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).

Bolus abciximab i.v. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).

Bolus of placebo followed by 12 h infusion (placebo).

Outcomes

Primary Outcome Measures

TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-month follow-up

Secondary Outcome Measures

1 Composite of death, stroke, repeat-MI, urgent target vessel revascularization and major bleedings at 30 days after rescue PCI
2 Composite of death, repeat-MI, repeat target vessel revascularization at 6 months following rescue PCI
3 Proportion of patients with platelet aggregation inhibition ≥ 95% and mean platelet aggregation inhibition 10 min post-bolus administration
4 Angiographic late loss and restenosis rate (diameter stenosis ≥ 50%) in the culprit artery
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

Full Information

First Posted
February 23, 2007
Last Updated
May 7, 2013
Sponsor
Olivier F. Bertrand
Collaborators
Eli Lilly and Company, Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00440895
Brief Title
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI and Rescue-PCI
Acronym
EASY-RESCUE
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olivier F. Bertrand
Collaborators
Eli Lilly and Company, Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

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, Rescue-PCI

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1 intracoronary + infusion
Arm Type
Experimental
Arm Description
Bolus abciximab i.c. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).
Arm Title
2 intravenous
Arm Type
Active Comparator
Arm Description
Bolus abciximab i.v. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).
Arm Title
3 Placebo
Arm Type
Placebo Comparator
Arm Description
Bolus of placebo followed by 12 h infusion (placebo).
Intervention Type
Drug
Intervention Name(s)
Abciximab
Other Intervention Name(s)
Abciximab (ReoPro)
Intervention Description
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).
Primary Outcome Measure Information:
Title
TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-month follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
1 Composite of death, stroke, repeat-MI, urgent target vessel revascularization and major bleedings at 30 days after rescue PCI
Time Frame
1 month
Title
2 Composite of death, repeat-MI, repeat target vessel revascularization at 6 months following rescue PCI
Time Frame
6 months
Title
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
Title
4 Angiographic late loss and restenosis rate (diameter stenosis ≥ 50%) in the culprit artery
Time Frame
6 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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
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

Learn more about this trial

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

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