Coronary Artery Disease (CAD) in patients undergoing Percutaneous Coronary Intervention (PCI) MedDRA version: 16.1 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery disorders System Organ Class: 100000004849
Conditions
Interventions
Product Name: pegnivacogin
Product Code: REG 1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pegnivacogin
Current Sponsor code: RB006
Other descriptive name: R01AZ
Concentration uni
Sponsors
Regado Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The study population will consist of patients with CAD undergoing PCI. Three key subgroups will be included as follows: a. Subgroup A: Patients with ischemic symptoms at rest and positive cardiac biomarkers (troponin I or T or creatine kinase-MB) related to an acute coronary syndrome event within 7 days; b. Subgroup B: Patients not meeting criteria for Subgroup A with at least one of the following risk factors: • Current presentation with an acute coronary syndrome with positive cardiac biomarkers >7 days prior to randomization • Current presentation with unstable angina (ACS without positive cardiac biomarkers) • Age >70 years • Diabetes • Chronic kidney disease (estimated CrCl =65 years) yes F.1.3.1 Number of subjects for this age range 6600
Exclusion criteria
Exclusion criteria: 1. Acute ST-segment elevation myocardial infarction within 48 hours of randomization; of the following: 2. Evidence of current clinical instability including the following: a. Sustained systolic blood pressure <90 mm Hg or cardiogenic shock; b. Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade; c. Suspected dissecting aortic aneurysm; 3. Evidence of a contraindication to anticoagulation or increased risk of bleeding such as: a. Any evidence or history of intracranial bleeding or intracranial aneurysm; b. Known hypercoagulable state, including treatment for malignancy (excluding basal cell skin carcinoma) in the past year, or coagulopathy with abnormal bleeding tendency; c. History of intraocular hemorrhage other than due to diabetic retinopathy; d. History of thrombocytopenia associated with abnormal bleeding; e. History of thrombocytosis associated with a thrombotic event; f. Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within 3 months; g. Prolonged cardiopulmonary resuscitation within 3 months; h. Major gastrointestinal bleeding within 3 months; i. Spontaneous genitourinary bleeding within 3 months; j. Any planned additional invasive procedure within 30 days after randomization; 4. Use of any investigational drug or device within 30 days of randomization or the planned use of an investigational drug or device through EOS (Day 30 follow-up); 5. Use of the following antithrombotic agents: a. Fibrinolytic agents within 48 hours; b. GP IIb/IIIa inhibitors within 24 hours; c. Bivalirudin within 24 hours d. Prior exposure to any component of REG1; 6. Baseline hemoglobin (Hgb) <9 g/dL or equivalent; 7. Renal impairment as determined by any one of the following: a. Baseline estimated glomerular filtration rate (GFR) = 10 mL/min/1.73m²; b. Currently undergoing renal replacement therapy (hemodialysis or peritoneal dialysis); c. Degree of renal impairment for which use of bivalirudin is prohibited or contraindicated per local label instructions; 8. Baseline platelet count <100,000/mm3 9. Known allergy or intolerance to aspirin, to all available ADP/P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor), or to bivalirudin or REG1 (or any of their respective components); ; 10. The following planned procedures: a. Planned staged PCI procedure within 30 days after randomization; b. Planned CABG or valve surgery within 30 days after randomization; 11. Any other medical or psychiatric condition that in the Investigator’s judgment precludes participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of REG1 compared to bivalirudin in patients with coronary artery disease (CAD) undergoing Percutaneous Coronary Intervention (PCI) for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent target lesion revascularization (TLR) through Day 3.;Secondary Objective: 1. Determine the efficacy of REG1 compared to bivalirudin for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke, urgent TLR and stent thrombosis (including intra-procedural) through Day 3. 2. Determine the safety of REG1 compared to bivalirudin on major hemorrhagic complications of PCI through Day 3 and Day 30. 3. Determine the efficacy of REG1 compared to bivalirudin for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 30. 4. Determine the efficacy of REG1 compared to bivalirudin in cardiac biomarker-positive patients for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3. 5. Determine the efficacy of REG1 compared to bivalirudin in cardiac biomarker-negative patients for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.;Primary end point(s): The composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.;Timepoint(s) of evaluation of this end point: Day 3 -10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The composite of death, nonfatal myocardial infarction, nonfatal stroke, urgent TLR and stent thrombosis (including intra-procedural) through Day 3; 2. Major non-CABG bleeding (Bleeding Academic Research Consortium [BARC] Types 3 and 5) through Day 3; 3. The composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 30; 4. The composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR in Subgroup A (cardiac biomarker-positive patients) through Day 3; 5. The composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR in Subgroups B and C (cardiac biomarker-negative patients) through Day 3. 6. Major non-CABG bleeding (BARC Types 3 and 5) through Day 30. Safety Endpoints 1. Incidence of bleeding (not related to CABG); 2. Incidence and severity of allergic adverse events, as well as the following: a. Immunologic biomarker analysis; b. Evaluations associated with risk mitigations strategies for possible allergic reactions; 3. Incidence of treatment emergent adverse events.;Timepoint(s) of evaluation of this end point: Through Day 3 and Day 30. | — |
Countries
Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactRaul Lima - Clinical Operations
Regado Biosciences, Inc.
Outcome results
None listed