A clinical trial to assess the role of Low dose Rivaroxaban and Aspirin for patients with Peripheral artery disease
- Conditions
- Health Condition 1: I702- Atherosclerosis of native arteriesof the extremities
- Registration Number
- CTRI/2020/11/029272
- Lead Sponsor
- pritee sharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
•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
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 < 1 year
Breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method imb Salvage and amputation free survival in Peripheral arterial diseaseTimepoint: 1st/3rd/6th/9th/12th month after initial assessment
- Secondary Outcome Measures
Name Time Method 1.Major adverse cardiac events (MACE): MI, Cardiovascular death, Stroke <br/ ><br>2.Major adverse limb events (MALE): Acute Limb ischemia, Amputation <br/ ><br>3.Bleeding events <br/ ><br>Timepoint: o1st/3rd/6th/9th/12th month after initial assessment