MedTrace Logo

Anticoagulation With rNAPc2 to Eliminate MACE/TIMI 32

NCT00116012 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2006-11-29

No results posted yet for this study

Summary

The primary focus of this study is to explore the safety of a range of doses of rNAPc2 in subjects who are managed in hospitals that most typically practice an early invasive strategy (catheterization during the index admission). After completion of the ascending dose-ranging part of the trial and review of these data by the Data and Safety Monitoring Board (DSMB), the maximum tolerated dose of rNAPc2 will be studied in single-arm, open-label panels (approximately 25 subjects each) of rNAPc2 with descending doses of unfractionated heparin (UFH).

Conditions

  • Coronary Disease

Interventions

DRUG

rNAPc2

Sponsors & Collaborators

  • The TIMI Study Group

    collaborator OTHER

  • ARCA Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven Deitcher, MD · ARCA Biopharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00116012 on ClinicalTrials.gov