A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Coronary Syndrome (ACS)	Drug: REG1 Drug: Heparin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin Dalteparin sodium

U.S. FDA Resources

Further study details as provided by Regado Biosciences, Inc.:

Primary Outcome Measures:

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

Enrollment:	640
Study Start Date:	July 2009
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: REG1-a Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)	Drug: REG1 IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
Experimental: REG1-b Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)	Drug: REG1 IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
Experimental: REG1-c Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)	Drug: REG1 IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
Experimental: REG1-d Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)	Drug: REG1 IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
Active Comparator: Heparin Heparin per standard of care at the local institution	Drug: Heparin IV dose per standard of care at the local institution Other Names: unfractionated heparin low molecular weight heparin

Detailed Description:

Primary Outcome Bleeding Secondary Outcome Ischemia

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932100

Show 43 Study Locations

Sponsors and Collaborators

Regado Biosciences, Inc.

Investigators

Principal Investigator:

John H Alexander, MD MHS FACC

Duke Clinical Research Institute

More Information

No publications provided by Regado Biosciences, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Povsic TJ, Cohen MG, Chan MY, Zelenkofske SL, Wargin WA, Harrington RA, Alexander JH, Rusconi CP, Becker RC. Dose selection for a direct and selective factor IXa inhibitor and its complementary reversal agent: translating pharmacokinetic and pharmacodynamic properties of the REG1 system to clinical trial design. J Thromb Thrombolysis. 2011 Jul;32(1):21-31.

Povsic TJ, Cohen MG, Mehran R, Buller CE, Bode C, Cornel JH, Kasprzak JD, Montalescot G, Joseph D, Wargin WA, Rusconi CP, Zelenkofske SL, Becker RC, Alexander JH. A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: design and rationale of the RADAR Phase IIb trial. Am Heart J. 2011 Feb;161(2):261-268.e1-2.

Responsible Party:	Regado Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT00932100 History of Changes
Other Study ID Numbers:	REG-CLIN211
Study First Received:	July 1, 2009
Last Updated:	March 1, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Regado Biosciences, Inc.:

ACS
Acute Coronary Syndrome
Catheterization

Additional relevant MeSH terms:

Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Calcium heparin
Heparin

Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013

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