Exploring the efficacy and safety of rivaroxaban to support elective percutaneous coronary intervention.

• Conditions: 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: 14.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001094-58-NL
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-30
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

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

1) Conditions that may increase the risk of the PCI procedure
oLesion-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)

oClinical 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 <90.000/µl at screening visit
•Fibrinolytics within 10 days before randomization
•Any other condition known to increase the risk of bleeding
3. Concomitant conditions or diseases, such as:
•Significant valvular heart disease
•Calculated creatinine clearance =30 mL/min
•Known liver disease or high concentrations of ALT (> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified