chest pain narrowing of the coronary artery
Conditions
Interventions
Study-specific intervention/therapy (e.g. apart from standardly performed PCI):
Patients participating in the study will receive 1 of the 2 doses rivaroxaban
(10 or 20 mg), or 10 mg rivaroxaban foll
Sponsors
Bayer
Eligibility
Age
18 Years to 99 Years
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.
Exclusion criteria
Exclusion criteria: 1) Conditions that may increase the risk of the PCI procedure • Lesion-specific conditions • Clinical condition at screening visit: 2) Conditions that may increase the risk of bleeding (e.g. a clinically significant gastrointestinal bleeding within 12 months before randomization; history of hemorrhagic stroke; active internal bleeding etc.) 3) Concomitant conditions or diseases (e.g. known HIV infection at time of screening; significant valvular heart disease etc.) 40 Concomitant medication (e.g. current use of anticoagulant drugs; Chronic treatment with non-steroidal anti-inflammatory drugs, NSAIDs) The complete list can be found in the protocol chapter 5.1.2 on page 33 till 35.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The anticoagulant effect will be determined during the index 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 MI due to the PCI procedure (i.e. procedural MI). Note: The PCI procedure starts when the target lesion is crossed with the guidewire and ends when the guiding catheter is removed and the subject has left the catheterization laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy variables - Separate components of the primary endpoint - Clinical ischemic events up to 30 days after index PCI assessed by the composite endpoint of: - All death - Non-fatal myocardial infarction (excluding those events due to the procedure alone and reported as primary endpoint) - Stroke - Clinically indicated target lesion revascularization (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 the Academic Research Consortium (ARC) definition11 Safety variables - Bleeding events up to 30 days after index PCI: - Incidence of clinically significant bleeding according to: - TIMI major - TIMI minor - Requiring medical attention - Incidence of bleeding according to BARC type 2, 3 and 5 - Any other SAEs up to 30 days after index PCI | — |
Countries
Netherlands
Outcome results
None listed