Acute coronary syndrome MedDRA version: 12.0 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery disorders
Conditions
Interventions
Product Name: RB006
Product Code: REG 1
Pharmaceutical Form: Solution for injection
Current Sponsor code: R01AZ
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentratio
Sponsors
Regado Biosciences, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any studyrelated activities; 2. Subject is male or female between the ages of 18–85 years (inclusive); 3. Chest pain or other ischemic symptoms a minimum of 10 minutes in duration within 72 hours of randomization and anticipated cardiac catheterization within 24 hours of randomization 4. 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 definition1 - Documented coronary artery disease as evidenced on prior angiography, or by prior angioplasty, bypass graft surgery, or myocardial infarction; 5. Subject is a female with a negative urine or serum pregnancy test orpost-menopausal for at least 1 year prior to randomization. Females of childbearing potential must be practicing adequate birth control to be eligible. It is the Investigator’s responsibility for determining whether the Subject has adequate birth control for study participation 6. Subject is able and willing to comply with the protocol and all study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Acute ST-segment elevation myocardial infarction; of the following criteria apply: 2. Subject has significant medical or psychiatric condition or other risk factor that in the opinion of the Investigator precludes participation in the study; 3. Subject weighs >120 kg; 4. Subject has evidence of clinical instability including the following: a. Sustained systolic blood pressure 180 mm Hg or diastolic >110 mm Hg); 6. Use of the following medications before the study: a. Use of any investigational drug or device within 30 days of signing consent or the planned use of an investigational drug or device through the EOS visit (Day 31); b. Use of low-molecular-weight heparin within 3 days of signing consent; c. Use of warfarin, bivalirudin, fibrinolytic agents or glycoprotein IIb/IIIa inhibitors within 7 days of signing consent; 7. Subject has clinically significant abnormal laboratory findings (from local clinical laboratory) that would preclude safe administration of study drug. Specifically, subject will be excluded if they meet the following: a. Baseline hemoglobin (Hgb) 2.5 times the upper limit of normal range; c. Platelet count <100,000/mm3 8. Planned use of femoral arterial sheath size greater than 7 French or Intra Aortic Balloon Pump or other support device, and/or any non-femoral vascular access approaches for index procedure; ; 9. Subject has known allergy or intolerance to aspirin, clopidogrel, and/or prasugrel or any other agent mandated by the study; 10. Subject has a history of illicit drug abuse in the past year or current evidence of such abuse in the opinion of the Investigator and; 11. Subject is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of the REG1 Anticoagulation System in Acute Coronary Syndrome patients undergoing cardiac catheterization by determination of the clinically acceptable dose range of RB007, which can be used to reliably reverse the anticoagulant effect of RB006.;Secondary Objective: 1. Estimate the efficacy of the REG1 System in suppressing ischemic events (death, nonfatal myocardial infarction, recurrent ischemia in target vessel distribution, or urgent target vessel revascularization) compared to heparin (UFH or LMWH); 2. Confirm the anti-Factor IXa activity of RB006 by pharmacodynamic coagulation measurements; 3. Determine if the target doses of RB007 yield the predicted pharmacodynamic observed responses; 4. Compare the time required to achieve anticoagulation and time to reverse anticoagulation for both the REG1 System and heparin; 5. Compare the length of hospitalization for subjects receiving the REG1 System to subjects receiving heparin; 6. Determine the feasibility of early sheath removal using the REG1 System; and 7. Determine the effect of different RB007 dose ranges on the reversal of RB006 anticoagulation as it relates to clinical and laboratory markers of anticoagulation;Primary end point(s): The composite incidence of major and minor bleeding (not related to CABG) through Day 30. | — |
Countries
France, Germany, Netherlands
Outcome results
None listed