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

Sponsor:	Olivier F. Bertrand
Collaborators:	Eli Lilly and Company Cordis Corporation
Information provided by (Responsible Party):	Olivier F. Bertrand, Laval University
ClinicalTrials.gov Identifier:	NCT00440895

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 IV

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:

MedlinePlus related topics: Heart Attack

Drug Information available for: Abciximab

U.S. FDA Resources

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 ]

Estimated Enrollment:	100
Study Start Date:	February 2007
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 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

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

Contacts

Contact: Olivier F Bertrand, MD, PhD	+1 418 656 8711	olivier.bertrand@crhl.ulaval.ca
Contact: Olivier JP Costerousse, PhD	+1 418 656 8711	olivier.costerousse@crhl.ulaval.ca

Locations

Canada
Laval Hospital	Recruiting
Quebec, Canada, G1V 4G5
Contact: Olivier F Bertrand, MD, PhD +1 418 656 8711 olivier.bertrand@crhl.ulaval.ca
Contact: Michele Jadin, MSc +1 418 656 8711 michele.jadin@crhl.ulaval.ca
Principal Investigator: Olivier F Bertrand, MD, PhD
Sub-Investigator: Eric Larose, MD, DVM
Sub-Investigator: Josep Rodes-Cabau, MD

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:	October 20, 2011
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
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on February 09, 2012