Comparison of Outcomes of Chronic Limb Threatening Ischemia in Diabetic and Hypertensive Patients With Hypercholesterolemia: Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin, in Mayo Hospital, Lahore
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Major Adverse Limb Events (MALEs)
研究概览
简要总结
The goal of this **clinical trial** is to compare the effectiveness of **low-dose rivaroxaban plus aspirin versus aspirin alone** in patients aged 40-70 years with **chronic limb-threatening ischemia, diabetes mellitus, hypertension, and hypercholesterolemia**. The main questions it aims to answer are:
- Does low-dose rivaroxaban plus aspirin reduce **major adverse limb events (MALE)**, such as acute limb ischemia and amputation?
- Does the combination therapy reduce **major adverse cardiovascular events (MACE)**, such as myocardial infarction and stroke, and improve limb-related outcomes?
Researchers will compare **low-dose rivaroxaban (2.5 mg twice daily) plus aspirin (75-100 mg daily)** with **aspirin alone** to see if combination therapy provides better outcomes over a period of **6 months**.
Participants will:
- Undergo baseline clinical assessment, blood tests, ABPI/TBI, and Doppler/duplex assessment.
- Be randomly assigned to either the rivaroxaban plus aspirin group or the aspirin-alone group.
- Attend follow-up visits at specified intervals for assessment of **WIFI score, ABPI, wound healing, MALE, MACE, and quality of life**.
- Be assessed for treatment compliance, side effects, and bleeding during follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of CLTI managed conservatively
- •ASA score of 3 or more
- •Age 40-70 yrs
- •Diagnosed case of Diabetes mellitus type 2 (HbA1c >8)
- •Blood Pressue ( >130/90 , <180/100 )
- •Hypercholestrolemia (Total cholesterol ≥200 mg/dL )
- •ABPI < 0.6
- •Claudication distance < 100 meters
- •Provided written informed consent (for prospective or interventional studies)
排除标准
- •Cholesterol >300mg/dl
- •HbA1c >12 mg/dl
- •Previous amputation or debridement of vascular ulcers
- •Diagnosed varicose veins
- •History of SEPS(subfacial endoscopic perforator surgery)
- •Active bleeding disorder
- •Recent major surgery (<1 month)
- •Renal failure requiring dialysis
- •Coagulopathy
- •Pregnancy or breastfeeding
研究组 & 干预措施
Aspirin
干预措施: Aspirin tablet (Drug)
Low-Dose Rivaroxaban and Aspirin,
Low dose Rivaroxaban 2.5 mg used orally twice a day in combination with Aspirin is a vascular protective dose as described in COMPASS and VOYEGAR PAD trials. This low dose has antithrombotic effect without full anticoagulation ,thus less bleeding risk compared to standard anticoagulant dose.
干预措施: Low-Dose Rivaroxaban Plus Aspirin, (Drug)
结局指标
主要结局
Major Adverse Limb Events (MALEs)
时间窗: 6 months
Major Adverse Cardiovascular Events
时间窗: 6 months
次要结局
未报告次要终点
研究者
javeria khalid
principle investigator
King Edward Medical University