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

NCT00440778 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2011-11-24

No results posted yet for this study

Summary

HYPOTHESES

1. Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration.
2. Total dose of abciximab can be given as a single bolus and is more effective than bolus (0.25 mg/kg) + 12 hrs infusion in terms of acute and mid-term angiographic and clinical results.
3. Intracoronary (ic) abciximab administration is more effective than intravenous (iv) route of administration in terms of acute and mid-term angiographic and clinical results.
4. There is a relationship between PAI and angiographic perfusion scores.
5. Routine use of sirolimus-eluting stents (Cypher, Cordis) in primary-PCI is associated with a low rate of target vessel revascularization and complications.
6. Cardiac MRI early and late after primary-PCI provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores.
7. After uncomplicated trans-radial PCI, patients can be retransferred early to their referring center.

Conditions

Interventions

DRUG

Abciximab

100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Cordis Corporation

    collaborator INDUSTRY

  • Quebec Heart Institute

    collaborator OTHER

  • Laval University

    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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-10-31
Completion
2008-10-31

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 NCT00440778 on ClinicalTrials.gov