Status:
COMPLETED
Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Cardiovascular Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Balloon angioplasty (Percutaneous Coronary Intervention (PCI)) is commonly used to treat patients with obstructive coronary artery disease (CAD). Although PCI is highly effective for the management of...
Eligibility Criteria
Inclusion
- Male or female subject aged 18 years or more with no upper age limit and willing to comply with the protocol
- Symptomatic coronary artery disease due to undergo an elective (non-emergent) Percutaneous Coronary Intervention (PCI) on one or two lesions in the native coronary vessel(s). Cardiac standard troponin at baseline is within the normal limits
Exclusion
- Conditions that may increase the risk of the PCI procedure
- Conditions that may increase the risk of bleeding
- Significant valvular heart disease
- Calculated creatinine clearance ≤30 mL/min
- Current use of anticoagulant drugs including Vitamin K antagonist (VKA), factor IIa or factor XA inhibitors
- Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs)
- Chronic treatment with aspirin \> 100mg
Key Trial Info
Start Date :
October 12 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2013
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01442792
Start Date
October 12 2011
End Date
March 4 2013
Last Update
June 23 2022
Active Locations (7)
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1
Hasselt, Belgium, 3500
2
Liège, Belgium, 4000
3
Roeselare, Belgium, 8800
4
Amsterdam, Netherlands, 1091 AC