A clinical trial to assess the role of Low dose Rivaroxaban and Aspirin for patients with Peripheral artery disease

Phase 4

Not yet recruiting

Conditions: Atherosclerosis of native arteriesof the extremities,

Registration Number: CTRI/2020/11/029272

Lead Sponsor: pritee sharma

Brief Summary: Rationale for the study:

Patientswith PAD are at heightened risk for major cardiovascular and adverse limbevents. The mainstay of treatment forpatients with peripheral artery disease includes use of antiplatelet agentdaily to prevent major adverse cardiovascular events. . Other antithromboticregimens have been tested in patients with peripheral artery disease includingvitamin K antagonists and newer antiplatelet agents including P2Y12 antagonistsused alone or in combination with aspirin, but none have been shown to besuperior to antiplatelet therapy alone. The peripheral artery disease analysisof the COMPASS trial showed that in stable PAD use of low-dose Rivaroxabantwice a day, together with aspirin once a day, reduced cardiovascular death,myocardial infarction, stroke, and acute limb ischaemia and amputation,compared with aspirin alone.

Patientspursue revascularization procedures to alleviate PAD symptoms and improvefunction. Post-revascularization PAD population high risk of subsequent vascular complications,particularly ALI. (17, 18)

The VOYAGER PAD showed significant benefitwith Rivaroxaban vascular dose and aspirin post revascularisation as comparedto standard antiplatelet therapy.

The Global Vascular Guidelines on the Management ofChronic Limb-Threatening Ischemia recommends low-dose aspirin and Rivaroxaban,2.5 mg twice daily, to reduce adverse cardiovascular events and lower extremityischemic events in patients with chronic limb threatening Ischemia. (Grade 2,Level of Evidence B)

PADpatients have different risk profiles throughout the disease spectrum.Therefore, studies in dedicated PAD populations, with a relevant PAD endpoints,are needed to identify optimal strategies to increase the limb salvage rates,amputation free survival and at the same time minimise adverse cardiac and limbevents. The aim of the study is to assess the role of low dose Rivaroxaban andaspirin in patients with peripheral artery disease.

**AIM:**

To assess therole of low dose Rivaroxaban and Aspirin in stable PAD patients and PADpatients post revascularisation.

**OBJECTIVE:**

Primary: Limb Salvage andamputation free survival in Peripheral arterial disease

Secondary:

1.    Major adversecardiac events (MACE): MI, Cardiovascular death, Stroke

2.    Major adverse limbevents (MALE): Acute Limb ischemia, Amputation

3.    Bleeding events

**Studydesign**

Prospective, single centre, Randomised controlledtrial

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

â€¢Stable PAD : Claudicant- functional limitations in walking activity â€¢Critical Limb Ischemia undergoing revascularisation (open surgery/ endovascular procedure/ hybrid procedure) for: ïƒ˜Ischemic rest pain ïƒ˜Ischemic tissue loss.

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 < 1 year Breast feeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Limb Salvage and amputation free survival in Peripheral arterial disease	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	2.Major adverse limb events (MALE): Acute Limb ischemia, Amputation

Trial Locations

Locations (1): Care Outpatient centre
🇮🇳
Hyderabad, TELANGANA, India
Care Outpatient centre
🇮🇳Hyderabad, TELANGANA, India
Pritee Sharma
Principal investigator
9650470040
priteepedgaonkar@gmail.com