Status:

UNKNOWN

Outcomes of Rivaroxaban and Aspirin in PAD After Endovascular Revascularization

Lead Sponsor:

Assiut University

Conditions:

Peripheral Arterial Disease

Eligibility:

All Genders

40+ years

Phase:

EARLY_PHASE1

Brief Summary

Assessing the outcomes of using Rivaroxaban plus Aspirin in patients with Lower Extremity Peripheral Arterial Disease after Endovascular Revascularization

Detailed Description

Globally more than 200 million people suffer from peripheral artery disease (PAD), and the incidence is rising due to advancing age, high rates of smoking in certain regions of the world, and the risi...

Eligibility Criteria

Inclusion

  • Age ≥40 .
  • Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease.
  • Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization.
  • Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
  • Subject has provided written informed consent.

Exclusion

  • Subject's age less than 40.
  • Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
  • Imminent or foreseeable amputation.
  • Subject already had a major amputation on the affected extremity
  • Subject has emergent ischemic lesion \[such as gas forming infection\].
  • Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre- treatment.
  • Subject is not in the position to be primarily revascularized or refuses surgery.
  • Acute embolic ischemia.

Key Trial Info

Start Date :

August 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2023

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT05308030

Start Date

August 1 2022

End Date

July 1 2023

Last Update

July 20 2022

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