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Serp-1 for the Treatment of Acute Coronary Syndrome

NCT00243308 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2009-02-06

No results posted yet for this study

Summary

Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2 contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for percutaneous coronary angioplasty. The primary objective of this study is to evaluate the safety of Serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.

Conditions

  • Unstable Angina
  • Coronary Atherosclerosis
  • Coronary Restenosis

Interventions

DRUG

Serine proteinase-1 (Serp-1)

Sponsors & Collaborators

  • Viron Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Alexandra Lucas, MD · Chief Clinical Officer- Viron Therapeutics

  • Jean-Claude Tardif, MD · Director- Montreal Heart Institute Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-07-31
Completion
2008-12-31

Countries

  • United States
  • Canada

Study Locations

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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 NCT00243308 on ClinicalTrials.gov