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Completed

NCT Number: NCT00932100

A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome

The purpose of this study is to evaluate the safety and efficacy of the REG1 anticoagulation System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization.

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Key information

Conditions

Acute Coronary Syndrome (ACS) Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver Hospital, Vancouver, British Columbia, Canada

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About this study

Primary Outcome Bleeding Secondary Outcome Ischemia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chest pain or other ischemic symptoms a minimum of 10 minutes in duration within 72 hours before anticipated cardiac catheterization;
  • At least one of the following criteria are met:
  • New or presumably new ST-segment depression of at least 1 mm or transient (30 minutes) ST-segment elevation of at least 1 mm in 2 contiguous leads;
  • Elevated troponin I, T, or creatine phosphokinase-MB isoenzyme level within 24 hours of signing consent as defined by the universal MI definition
  • Documented coronary artery disease as evidenced on prior angiography, or by prior angioplasty, bypass graft surgery, or myocardial infarction

Exclusion criteria

  • Acute ST-segment elevation myocardial infarct
  • Anticipated inability to perform angiography within 24 hours of dosing
  • Evidence of clinical instability
  • Contraindications to anticoagulant use
  • Recent cardiac intervention
  • Clinically abnormal laboratory or test findings during screening
  • Subject is pregnant or lactating

Treatment and study plan

REG1

Drug

IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention

Heparin

Drug

IV dose per standard of care at the local institution

Other names: unfractionated heparin, low molecular weight heparin

Primary outcomes

  1. The composite incidence of major and minor bleeding

    Time frame: Through Day 30

Sponsors and collaborators

Lead sponsor

Regado Biosciences, Inc.

Industry

Registry information

Acronym: RADAR

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 3, 2009
Registry last updated
Mar 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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