Symptomatic CAD patients due to undergo an elective (non emergent) Percutaneous Coronary Intervention (PCI) on one or two lesions in the native coronary vessel(s). MedDRA version: 13.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: UnFractionated Heparin (UFH)
Product Name: Unfractionated heparin (UFH
Product Code: Unfractionated heparin
Pharmaceutical Form: Injection
INN or Proposed INN: Heparin
CAS Number: 9005-49-
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female subject aged 18 years or more with no upper age limit and willing to comply with the protocol. 2) Symptomatic coronary artery disease due to undergo an elective (non- emergent) PCI on one or two lesions in the native coronary vessel(s). Cardiac standard troponin at baseline is within the normal limits. 3) Subject is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC after receiving detailed written and oral information prior to any study specific procedures. 4) Ability to understand and follow study-related instructions. 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 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1) Conditions that may increase the risk of the PCI procedure o Lesion-specific conditions: - Left main coronary artery disease - Chronic Total Occlusions - Bifurcation lesions involving a contiguous side branch with a diameter bigger or equal to 2.5mm by visual estimate - Three vessel disease requiring treatment of more than 2 lesions (no staging is allowed) o Clinical condition at screening visit: - ST-segment elevation myocardial infarction within 14 days prior to randomization - New York Heart Association class III or IV congestive heart failure - Hemodynamic instability - Severe hypertension not adequately controlled by antihypertensive therapy at the time of the study entry (BP > 180/110mmHg) 2) Conditions that may increase the risk of bleeding, but are not limited to the following: • Active internal bleeding • Clinically significant gastrointestinal bleeding within 12 months before randomization • History of intracranial, intraocular, spinal, or atraumatic intraarticular bleeding • History of hemorrhagic stroke • Major surgery (including CABG), biopsy of a parenchymal organ, ophthalmic surgery, or serious trauma (including head trauma) within 30 days before randomization • Known intracranial neoplasm, cerebral metastases, arteriovenous malformation, or aneurysm at time of screening • Known coagulopathy or bleeding diathesis (including congenital bleeding disorders such as von Willebrand’s disease or hemophilia; acquired bleeding disorders; and unexplained clinically significant bleeding disorders) • Platelet count 3x the upper limit of normal) • Known allergy, hypersensitivity or contraindication to aspirin, clopidogrel, heparin, rivaroxaban or contrast media • Known HIV infection at time of screening • Any other medical condition requiring systemic anticoagulation therapy • Lactating/pregnant women • Treatment with other investigational drugs or devices within 30 days before enrolment or planned use of investigational drugs or devices during the study • Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting of performing study requirements • Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator 4. Concomitant medication: • Current use of anticoagulant drugs including VKA. factor IIa, of Factor Xa inhibitors. • Systemic treatment with strong inhibitor or/and inducer of CYP3A4 • Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs) • Chronic treatment with aspirin > 100mg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess whether rivaroxaban, as compared to unfractionated heparin, on the background of standard dual antiplatelet therapy (DAPT), can effectively suppress thrombosis, and related adverse ischemic events, upon balloon inflation and stent expansion, during elective PCI, without increasing bleeding.;Secondary Objective: To investigate the safety of rivaroxaban plus DAPT in the setting of elective PCI. Secondary objectives are safety criteria with respect to bleeding (TIMI major, TIMI monor and BARC type 2, 3 and 5) and the composite of clinical ischemic events (all death, non-fatal myocardial infarction [MI], non-fatal stroke and Target Lesion Revascularization [TLR]) be determined up to 30 days. ;Primary end point(s): The anticoagulant effect will be determined during the PCI procedure based on the number of subjects who: - require bail-out anticoagulant therapy in the context of an ischemic coronary event and/or - experience an angiographic flow limiting thrombotic event (i.e. abrupt vessel closure, visible thrombus, no-reflow) and/or - experience thrombus formation on the PCI equipment (i.e. guiding catheter and guidewire thrombus) and/or - experience an Myocardial Infarction (MI) due to the PCI procedure (i.e. procedural MI) ;Timepoint(s) of evaluation of this end point: Day 1 (the day of the PCI procedure). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy variables: - Separate components of the primary endpoint - Clinical ischemic events up to 30 days after index PCI assessed by the compositeendpoint of: o All death o Non-fatal myocardial infarction (excluding those events due to the procedure alone and reported as primary endpoint) o Stroke o Clinically indicated TLR - The incidence of clinically indicated TLR up to 30 days after index PCI - Definite and probable stent thrombosis up to 30 days after index PCI according to theAcademic Research Consortium (ARC) definition Safety variables: - Bleeding events up to 30 days post index PCI procedure: o Incidence of clinically significant bleeding according to: - TIMI major - TIMI minor - Requiring medical attention o Incidence of bleeding according to BARC type 2, 3 and 5 - Any other SAEs up to 30 days post index PCI procedure.;Timepoint(s) of evaluation of this end point: till 30 days + 7 days. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactCTP Team /Ref:"EU CTR"/
Bayer HealthCare AG
Outcome results
None listed