Peripheral artery disease MedDRA version: 20.0 Level: LLT Classification code 10053375 Term: Peripheral revascularization System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Xarelto 2.5 mg film-coated tablets
Product Name: Rivaroxaban 2.5mg
Product Code: BAY 59-7939
Pharmaceutical Form: Film-coated tablet
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =50 - Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease as evidenced by ALL of the following: a. clinically, by functional limitations in walking activity, ischemic rest pain, or ischemic ulceration, b. anatomically, by imaging evidence of peripheral artery disease distal to the external iliac artery in the index leg within 12 months prior to or at the time of the qualifying revascularization AND c. hemodynamically in either leg (within 12 months prior to, or at the time of, the qualifying revascularization) by: an ABI = 0.80 or TBI = 0.60 for patients without a prior history of limb revascularization, OR an ABI = 0.85 or TBI = 0.65 for patients with a prior history of limb revascularization; - Technically successful peripheral revascularization distal to the external iliac artery (surgical and/or endovascular; for definition see Section 9.3.3) for symptomatic PAD within the last 10 days prior to randomization - Written informed consent by patient or his/her legal representative; - Patient understands and is willing and able to comply with the study instructions and follow-up visit; - Negative serum pregnancy test (in women of childbearing potential only); - Women of reproductive potential must agree to use adequate contraception* when sexually active. This applies for the time period between signing of the informed consent form (ICF) to the last administration of study drug. (*The definition of adequate contraception [with a failure rate of less than 1% per year] will be based on the judgment of the investigator and on local requirements. Acceptable methods of contraception include, but are not limited to: oral contraceptives, contraceptive injections, intrauterine device, double barrier method, male partner sterilization 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 2210 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4290
Exclusion criteria
Exclusion criteria: - Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg - Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis - Prior revascularization on the index leg within 10 days of the qualifying revascularization; - Acute limb ischemia (ALI) within 2 weeks prior to the qualifying revascularization. - Patients with major tissue loss (defined as significant ulceration/gangrene proximal to the metatarsal heads, i.e. heel or midfoot) in either leg; Exclusion criteria related to concomitant and study treatment: - Patients requiring treatment with ASA at doses >100 mg; - Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to ASA for >6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drug coated products or devices), and is only allowed for up to 6 months for complex procedures or devices that in the investigator's opinion require longer use; see section 8.1 for further guidance on clopidogrel; - Planned* use of any additional antiplatelet agent other than clopidogrel and ASA after the qualifying revascularization procedure (*This exclusion criterion refers to the clinical condition at the time of randomization. The use of DAPT with ASA plus clopidogrel, for new indication(s) occurring after randomization is permitted); Exclusion criteria related to bleeding risks or systemic conditions: - Medical history or active clinically significant bleeding, lesions, or conditions within the last 6 months prior to randomization, considered to be a significant risk for major bleeding (this may include current medically confirmed gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, current or recent brain or spinal injury, known esophageal varices, vascular aneurysms of the large arteries or major intraspinal or intracerebral vascular abnormalities); Other exclusion criteria: - Previous (within 30 days) or concomitant participation in another clinical study with investigational product (s); - Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person (e.g., employee or student of the investigational site). - Breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether rivaroxaban added to acetylsalicylic acid (ASA) is superior to ASA alone in reducing the risk of major thrombotic vascular events (defined as myocardial infarction (MI), ischemic stroke, cardiovascular (CV) death, acute limb ischemia (ALI), and major amputation of a vascular etiology) in symptomatic PAD patients undergoing lower extremity revascularization procedure. To evaluate the overall safety and tolerability of rivaroxaban added to ASA compared to ASA alone. ; Secondary Objective: - To evaluate whether rivaroxaban + ASA is superior to ASA alone in reducing the risk of MI, ischemic stroke, coronary heart disease mortality, ALI, and major amputation of a vascular etiology; - To evaluate whether rivaroxaban + ASA is superior to ASA alone in reducing the risk of an unplanned index limb revascularization for recurrent limb ischemia (subsequent index leg revascularizations that were not planned or considered as part of the initial treatment plan at the time of randomization) - To evaluate whether rivaroxaban + ASA is superior to ASA alone in reducing the risk of MI, ischemic stroke, all-cause mortality, ALI, and major amputation of a vascular etiology; - To evaluate whether rivaroxaban + ASA is superior to ASA alone in reducing the risk of vascular hospitalizations for a coronary or peripheral event (either limb) of a thrombotic nature; See Protocol section 4 for the full list of objectives ; Primary end point(s): 1. Time from randomization to the first occurrence of any of the following major thrombotic vascular events: MI (Myocardial infarction), ischemic stroke, CV (Cardiovascular) death, ALI (Acute limb ischemia), and major amputation 2. Time from randomization to first occurrence of major bleeding events according to the Thrombolysis in Myocardial Infarct | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Approximately 2 years; Secondary end point(s): 1. Time from randomization to first occurrence of an index limb revascularization 2. Time from randomization to the first occurrence of an index limb revascularization (subsequent index leg revascularization that was not planned or considered as part of the initial treatment plan at the time of randomization) 3. Time from randomization to first occurrence of myocardial infarction, ischemic stroke, all-cause mortality,acute limb ischemia, and major amputation of a vascular etiology 4. Time from randomization to first occurrence of hospitalization for a coronary or peripheral cause (either lower limb) of a thrombotic nature 5. Time from randomization to first occurrence of myocardial infarction, all-cause stroke, cardiovascular death, acute limb ischemia, and major amputation of a vascular etiology 6. Time from randomization to first occurrence of venous thromboembolic (VTE) events 7. Time from randomization to all-cause mortality | — |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed