CTRI/2020/11/029272尚未招募4 期
Role of low dose Rivaroxaban and Aspirin in Peripheral artery disease- A Randomised control Trial
pritee sharma0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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