Patients with coronary heart disease who will be undergoing non-urgent Percutaneous Coronary Intervention (PCI)
Conditions
Interventions
Product Name: otamixaban
Product Code: XRP0673
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: otamixaban
CAS Number: 219672-50-1
Current Sponsor code: XRP0673
Concent
Sponsors
Aventis Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Men or women = 18 years of age · Due to undergo non-urgent PCI with a femoral approach, with balloon angioplasty (with or without stent) of a single or multiple sites of native vessel(s) during the same procedure · Planned treatment with aspirin and clopidogrel prior to PCI (unless allergic to one of these medications). · Informed consent obtained in writing at enrollment into the study (oral consent alone is not allowed) 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: General · Breastfeeding or pregnancy · Inability to give informed consent or high likelihood of being unavailable for Day 31 follow-up · Treatment with other investigational agents (including placebo) or devices within 30 days days prior to enrollment or planned use of investigational drugs or devices during the study Cardiovascular · Onset of acute coronary syndrome (STEMI, unstable angina/NSTEMI) within 48 hours prior to randomization . Ischemic discomfort at rest within 24 hours prior to randomization · Congestive heart failure of New York Heart Association class III or IV at enrollment · Hemodynamic instability at enrollment · Significant valvular disease with hemodynamic impairment · Radial approach for the planned PCI Related to bleeding risk · Active or recent ( 180 mmHg or diastolic blood pressure > 110 mmHg) · Past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand’s disease or hemophilia, acquired bleeding disorders, or unexplained repeated bleeding episodes) Related to prior/concomitant medications · Chronic daily use of NSAIDs or oral corticosteroids · Thrombolytic therapy within the previous 14 days · History of hypersensitivity or contraindication to unfractionated heparin · Treatment with unfractionated heparin, enoxaparin, nadropirin, dalteparin, reviparin, or bivalirudin within the 12 hours preceding randomization . Treatment with tinzaparin or fondaparinux within 24 hours preceding randomization · Treatment with abciximab within 10 days prior to randomization · Treatment with eptifibatide or tirofiban within 12 hours prior to randomization Laboratory values · Known thrombocytopenia (platelet count = 100 000/µL) at enrollment · Known international normalized ratio (INR) > 1.2 at enrollment · Known estimated creatinine clearance = 30 mL/min at enrollment (Cockroft and Gault formula) · Known clinically significant anemia (hemoglobin < 10 g/dL) at enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: in subjects undergoing non-urgent percutaneous coronary intervention (PCI): · to determine the effect of several intravenous (IV) regimens of otamixaban on the pharmacodynamic marker F1 + F2 (marker of thrombin generation) at the end of the infusion, as compared to IV unfractionated heparin (UFH) · and to determine the effect of several IV regimens of otamixaban on the pharmacodynamic marker anti-factor Xa (anti-FXa) activity at the end of the infusion. ;Secondary Objective: to identify a safe range of dosages of IV otamixaban in comparison to UFH. Safety and tolerability will include: · assessments of bleeding, based on the incidence of the composite endpoint of TIMI major, minor and minimal bleeding episodes up to Day 3 or hospital discharge (whichever comes first), composite endpoint of TIMI major and minor bleeds, and the components TIMI major bleeds, and TIMI minor bleeds · adverse events (AEs) and laboratory safety data to assess the effect of several IV regimens of otamixaban on clinical efficacy, as represented by the incidence of the composite endpoint of death, myocardial infarction (MI), and target vessel revascularization (urgent and non-urgent) for 30 days after randomization ;Primary end point(s): The primary analysis variables are the following two pharmacodynamic markers: · F1 + F2 (marker of thrombin generation) change from baseline assessed at the end of the 3-hour infusion · anti-FXa activity assessed at the end of the 3-hour infusion | — |
Countries
Czech Republic, Slovakia, Spain
Outcome results
None listed