Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia

Inclusion criteria

• Written informed consent.
• Infra-inguinal PAD presenting as CLI defined as a Rutherford category of 3, 4, or 5
• More than 50% stenosis in the target infrainguinal vessel
• Good candidates for PTA using POBA (plain old balloon angioplasty) with or without stenting defined as TASC a and b lesions.

Exclusion criteria

• Rutherford scale of 0,1,2 or 6
• Acute limb-threatening ischemia (e.g. embolic disease)
• Previous infrainguinal bypass or PTA procedures of the affected leg
• Hybrid procedures
• Creatinine clearance <30 mL/min
• Platelet count <100x109/L
• INR >1.5; Hbg <100 g/L
• History of or condition associated with increased bleeding risk including, but not limited to:

• Major surgical procedure or trauma within 30 days before the randomization visit
• Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
• History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
• Chronic hemorrhagic disorder
• Known intracranial neoplasm, arteriovenous malformation, or aneurysm
• Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
• Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive) within 3 months or any stroke within 14 days before the randomization visit
• Aspirin in combination with thienopyridines within 5 days before randomization
• Intravenous antiplatelets within 5 days before randomization
• Fibrinolytics within 10 days before randomization
• Known HIV infection at time of screening
• Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT >3ULN)
• Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
• Drug addiction or alcohol abuse within 12 months before the randomization visit
• Systemic treatment with strong CYP 3A4 and P-glycoprotein inhibitors : such as ketoconazole, itraconazole, posaconazole, or ritonavir
• Known allergy or hypersensitivity to any component of rivaroxaban, ASA or clopidogrel
• Need for long term anticoagulation or double antiplatelet agents other than PAD such as atrial fibrillation, heart valve replacement, acute coronary syndrome, stroke or venous thromboembolism
• Anticipated need for chronic (> 4 weeks) therapy with non-steroidal anti-inflammatory drugs.
• Concomitant treatment with any other anticoagulant, including oral anticoagulants, such as warfarin, dabigatran, apixaban, except under circumstances of switching therapy to or from study treatment.
• Inability to adhere to protocol.
• Severe concomitant condition or disease (e.g. life expectancy <6 months secondary to cancer, advanced liver disease or dementia)