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

Regado Biosciences

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome (ACS)

Treatments: Drug: Heparin; Drug: REG1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00932100

REG-CLIN211

Details and patient eligibility

About

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.

Full description

Primary Outcome Bleeding Secondary Outcome Ischemia

Enrollment: 640 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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640 participants in 5 patient groups

REG1-a

Experimental group

Description:

Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

Treatment:

Drug: REG1

REG1-b

Experimental group

Description:

Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

Treatment:

Drug: REG1

REG1-c

Experimental group

Description:

Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

Treatment:

Drug: REG1

REG1-d

Experimental group

Description:

Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

Treatment:

Drug: REG1

Heparin

Active Comparator group

Description:

Heparin per standard of care at the local institution

Treatment:

Drug: Heparin