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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Regado Biosciences, Inc.

ClinicalTrials.gov Identifier:

NCT00932100

First received: July 1, 2009

Last updated: March 1, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 1, 2009

Last Updated Date

March 1, 2012

Start Date ^ICMJE

July 2009

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The composite incidence of major and minor bleeding [ Time Frame: Through Day 30 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00932100 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Primary Outcome Bleeding Secondary Outcome Ischemia

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Coronary Syndrome (ACS)

Intervention ^ICMJE

Drug: REG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
Drug: Heparin
IV dose per standard of care at the local institution
Other Names:
- unfractionated heparin
- low molecular weight heparin

Study Arm (s)

Experimental: REG1-a
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

Intervention: Drug: REG1
Experimental: REG1-b
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

Intervention: Drug: REG1
Experimental: REG1-c
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

Intervention: Drug: REG1
Experimental: REG1-d
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

Intervention: Drug: REG1
Active Comparator: Heparin
Heparin per standard of care at the local institution

Intervention: Drug: Heparin

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

640

Completion Date

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:
1. 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;
2. Elevated troponin I, T, or creatine phosphokinase-MB isoenzyme level within 24 hours of signing consent as defined by the universal MI definition
3. 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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, France, Germany

Administrative Information

NCT Number ^ICMJE

NCT00932100

Other Study ID Numbers ^ICMJE

REG-CLIN211

Has Data Monitoring Committee

Yes

Responsible Party

Regado Biosciences, Inc.

Study Sponsor ^ICMJE

Regado Biosciences, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

John H Alexander, MD MHS FACC

Duke Clinical Research Institute

Information Provided By

Regado Biosciences, Inc.

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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