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

NCT00440895 | Completed Phase 4 DMC

• 1 other identifier: EASY-RESCUE
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Ischemia

Keywords

Coronary artery stenting; Trans-radial; Intracoronary; Rescue-PCI

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (5)

• 1 Composite of death, stroke, repeat-MI, urgent target vessel revascularization and major bleedings at 30 days after rescue PCI

  1 month

• 2 Composite of death, repeat-MI, repeat target vessel revascularization at 6 months following rescue PCI

  6 months

• 3 Proportion of patients with platelet aggregation inhibition ≥ 95% and mean platelet aggregation inhibition 10 min post-bolus administration

  10 min post PCI

• 4 Angiographic late loss and restenosis rate (diameter stenosis ≥ 50%) in the culprit artery

  6 months

• 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

  6-hr post PCI to hospital discharge

Study Arms (3)

1 intracoronary + infusion

EXPERIMENTAL

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

Drug: Abciximab

2 intravenous

ACTIVE COMPARATOR

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

Drug: Abciximab

3 Placebo

PLACEBO COMPARATOR

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

Drug: Abciximab

Interventions

Abciximab DRUG

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).

Also known as: Abciximab (ReoPro)

1 intracoronary + infusion; 2 intravenous; 3 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Olivier F. Bertrand: lead
• Eli Lilly and Company: collaborator
• Cordis US Corp.: collaborator

Study Sites (1)

Laval Hospital

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Myocardial Infarction; Ischemia

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Olivier F Bertrand, MD, PhD

  Laval Hospital Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: May 1, 2013
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

CA (1)