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A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention

NCT01327183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2016-11-02

No results posted yet for this study

Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.

Conditions

Interventions

PROCEDURE

Percutaneous Coronary Intervention (PCI)

at least 1 hour and up to 24 hours after completion of drug infusion

DRUG

RO4905417

5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI

DRUG

RO4905417

20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI

DRUG

placebo

iv infusion, completed at least 1 hour and up to 24 hours before PCI

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States
  • Canada
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Drugs
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 NCT01327183 on ClinicalTrials.gov