A multinational, randomized, double-blind, double-dummy, exploratory, parallel-group, dose-ranging phase II study to evaluate the pharmacodynamics, the safety and tolerability, and the pharmacokinetics of several intravenous regimens of the factor Xa inhibitor otamixaban (XRP0673), in comparison to intravenous unfractionated heparin, in subjects undergoing non-urgent Percutaneous Coronary Intervention. - The SEPIA-PCI Trial
- Conditions
- Patients with coronary heart disease who will be undergoing non-urgent Percutaneous Coronary Intervention (PCI)
- Registration Number
- EUCTR2004-000904-41-ES
- Lead Sponsor
- Aventis Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 930
· 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
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 (< 3 months) significant bleeding, including gastrointestinal bleeding or gross hematuria
· Ischemic stroke within 12 months or history of any previous hemorrhagic stroke
· Known structural damage or other pathologic process involving the central nervous system (including, but not limited to, intracranial tumor or intracerebral vascular malformation)
· Recent (< 1 month) trauma (including cardiac resuscitation), major surgery (including bypass surgery) or parenchymal organ biopsy
· Uncontrolled arterial hypertension (systolic blood pressure > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method