Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease

Study Overview
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Brief Summary
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EFFECTIVENESS OF COMBINED ANTICOAGULATION AND ANTITHROMBOTIC THERAPY VS ANTITHROMBOTIC THERAPY ALONE AFTER LOWER EXTREMITY REVASCULARIZATION FOR PERIPHERAL ARTERIAL DISEASE.

Detailed Description
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Anticoagulation and antithrombotic therapy is a crucial part of PAD management as it prolongs the patecy of grafts in open surgical revascularization procedures so its proper dosage and duration without increasing risks to the patient and maximizing the benefits is very important. Currently literature in Pakistan regarding this problem couldn't be found so this study would help assessing the outcomes of anticoagulation and antithrombotic therapy in this population with respect to treatment options available and presentation variability of the peripheral arterial disease. Patients with PAD would be enrolled for 6 months and would be followed upto 12 months and then upto 24 months. Eligible subjects will be randomized 1:1 to receive either rivaroxaban 5 mg twice daily plus aspirin 75 mg once daily or rivaroxaban-matching placebo twice daily plus aspirin 75 mg once daily stratified by type of procedure; the treatment assignment will be double-blinded. Randomization and study treatment will begin as soon as possible but no later than 10 days after a successfull lower extremity revascularization. Patients will be prohibited from taking any additional antithrombotic therapy other drugs, including anticoagulants, doses of aspirin >100 mg daily, vorapaxar, ticagrelor, prasugrel, or cilostazol. Enrolled subjects will be having symptomatic PAD defined by evidence of an abnormal ankle-brachial index ≤0.80 in either limb with an anatomy of occlusive disease of involving segments. Subjects would be randomized who had undergone a technically successful endovascular, hybrid, or surgical LER within 10 days and had achieved adequate hemostasis before randomization.

Official Title
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Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease

Conditions
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Combined Anticoagulation and Antithrombotic Therapy, PAD - Peripheral Arterial Disease

Intervention / Treatment
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* Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - all patients with PAD candidates for revascularization procedures Exclusion Criteria: planned long-term dual antiplatelet therapy (>6 months), clinical requirement for therapeutic anticoagulation, recent acute limb ischemia or acute coronary syndrome, medical condition that could increase the risk of major bleeding, significantly impaired renal function at baseline (estimated glomerular filtration rate <15 mL•min-1•1.73 m-2), any documented history of intracranial hemorrhage, stroke, or transient ischemic attack

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients enrolled in the study would be taken informed consent and divided in two groups, group A receiving rivaroxaban plus aspirin and Group B receiving placebo plus aspirin
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A(combined anticoagulation plus antithrombotic therapy group)<br>group A patients would be receiving rivaroxaban and aspirin as experimental group to see the efficacy of rivaroxaban in peripheral arterial disease. | Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]<br>* rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival<br>|
| Active Comparator: Group B( antithrombotic therapy alone group)<br>group B patients would be those receiving traditional antithrombotic therapy as usually given n Peripheral Arterial Disease. | Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]<br>* rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALI | acute limb ischemia | upto 1 year | 
| major amputation for vascular reasons | any type of major amputation after revascularivation for PAD | upto 1 year | 
| MI | myocardial infarction | upto 1 year | 
| ischemic stroke | ischemic stroke | upto 1 year | 
| cardiovascular death | death because of cardiovascular events | upto 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thrombolysis in myocardial infarction(TIMI)major bleeding | combined therapy effect may result in increased bleeding tendency | 2, 30, 180 and 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rivaroxaban in PAD