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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Cordis Corporation
Information provided by (Responsible Party):
Olivier F. Bertrand, Laval University
ClinicalTrials.gov Identifier:
NCT00440895
First received: February 23, 2007
Last updated: May 7, 2013
Last verified: May 2013
  Purpose
  • 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.

Condition Intervention Phase
Myocardial Infarction
Ischemia
Drug: Abciximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-month follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1 Composite of death, stroke, repeat-MI, urgent target vessel revascularization and major bleedings at 30 days after rescue PCI [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • 2 Composite of death, repeat-MI, repeat target vessel revascularization at 6 months following rescue PCI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 4 Angiographic late loss and restenosis rate (diameter stenosis ≥ 50%) in the culprit artery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: February 2007
Study Completion Date: May 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 intracoronary + infusion
Bolus abciximab i.c. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).
Drug: Abciximab
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).
Other Name: Abciximab (ReoPro)
Active Comparator: 2 intravenous
Bolus abciximab i.v. (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).
Drug: Abciximab
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).
Other Name: Abciximab (ReoPro)
Placebo Comparator: 3 Placebo
Bolus of placebo followed by 12 h infusion (placebo).
Drug: Abciximab
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).
Other Name: Abciximab (ReoPro)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440895

Locations
Canada
Laval Hospital
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Olivier F. Bertrand
Eli Lilly and Company
Cordis Corporation
Investigators
Principal Investigator: Olivier F Bertrand, MD, PhD Laval Hospital Research Center
  More Information

No publications provided

Responsible Party: Olivier F. Bertrand, MD PhD, Laval University
ClinicalTrials.gov Identifier: NCT00440895     History of Changes
Other Study ID Numbers: EASY-RESCUE
Study First Received: February 23, 2007
Last Updated: May 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Coronary artery stenting
Trans-radial
Intracoronary
Rescue-PCI

Additional relevant MeSH terms:
Infarction
Ischemia
Myocardial Infarction
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Abciximab
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014