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

NCT00440895 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2013-05-08

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Cordis Corporation

    collaborator INDUSTRY

  • Olivier F. Bertrand

    lead OTHER

Principal Investigators

  • Olivier F Bertrand, MD, PhD · Laval Hospital Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2012-10-31
Completion
2013-05-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00440895 on ClinicalTrials.gov