Prospective, multi-center, randomized, heparin-controlled dose-finding trial to evaluate the efficacy and safety of rivaroxaban, a direct factor Xa inhibitor, on the background of standard dual antiplatelet therapy to support elective percutaneous coronary intervention (X-Plorer).
- Conditions
- chest painnarrowing of the coronary artery10011082
- Registration Number
- NL-OMON35762
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The anticoagulant effect will be determined during the index PCI procedure<br /><br>based on the number of subjects who:<br /><br><br /><br>-Require bail-out anticoagulant therapy in the context of an ischemic coronary<br /><br>event, and/or<br /><br>-Experience an angiographic flow limiting thrombotic event (i.e. abrupt vessel<br /><br>closure, visible thrombus, no-reflow) and/or<br /><br>-Experience thrombus formation on the PCI equipment (i.e. guiding catheter and<br /><br>guidewire thrombus) and/or<br /><br>-Experience an MI due to the PCI procedure (i.e. procedural MI).<br /><br><br /><br>Note: The PCI procedure starts when the target lesion is crossed with the<br /><br>guidewire and ends when the guiding catheter is removed and the subject has<br /><br>left the catheterization laboratory.</p><br>
- Secondary Outcome Measures
Name Time Method