Health Condition 1: I702- Atherosclerosis of native arteriesof the extremities
Conditions
Interventions
Intervention1: RIVAROXABAN: Tab Rivaroxaban 2.5 mg twice daily oral lifelong
Sponsors
pritee sharma
P C Gupta
Eligibility
Inclusion criteria
Inclusion criteria: • Stable PAD : Claudicant- functional limitations in walking activity • Critical Limb Ischemia undergoing revascularisation (open surgery/ endovascular procedure/ hybrid procedure) for: ï?? Ischemic rest pain ï?? Ischemic tissue loss
Exclusion criteria
Exclusion criteria: Patient requiring systemic anticoagulation for any other reason Patient requiring dual anti platelets for any other reason. Systemic treatment with strong inhibitors of both Cytochrome P450 isoenzyme 3A4 (CYP3A4) and p-glycoprotein (P-gp) inhibitors (e.g., systemic azole antimycotics, such as ketoconazole fluconazole is permitted], and human immunodeficiency virus [HIV]- protease inhibitors, such as ritonavir), or strong inducers of CYP3A4 (e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine) 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) Hypersensitivity or any other contraindication listed in the local labeling for Aspirin or Rivaroxaban Any known hepatic disease associated with coagulopathy or bleeding risk Any condition requiring dialysis or renal replacement therapy. Confirmed acute coronary syndrome (ACS) within 30 days prior to initial assessment Major trauma or accidents within 30 days prior to initial assessment Any medically documented history of intracranial haemorrhage, stroke, or transient ischemic attack (TIA) Known active malignancy (as determined through review of medical history), excluding local skin cancer (basal or squamous cell carcinoma) Severe uncontrolled hypertension (at the discretion of investigator) Overall life expectancy Breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Limb Salvage and amputation free survival in Peripheral arterial diseaseTimepoint: 1st/3rd/6th/9th/12th month after initial assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Major adverse cardiac events (MACE): MI, Cardiovascular death, Stroke 2. Major adverse limb events (MALE): Acute Limb ischemia, Amputation 3. Bleeding events Timepoint: o 1st/3rd/6th/9th/12th month after initial assessment | — |
Countries
India
Contacts
Public ContactPritee Sharma
Care Hospital
Outcome results
None listed