Outcomes of Rivaroxaban and Aspirin in PAD After Endovascular Revascularization

NCT05308030 | Unknown Early Phase 1

• 1 other identifier: Rivaroxaban in PAD after ER
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Patency

  Determination of patency of the target limb is essentially by measuring Ankle brachial Index(ABI)

  One year

Interventions

Rivaroxaban and Aspirin DRUG

After the endovascular intervention, Anticoagulant therapy plus Antiplatelet therapy will be maintained (Aspirin 100 mg once daily and Rivaroxaban 2.5 mg twice daily) for 3 months, and then Aspirin alone indefinitely

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Ahmed Hassan Elshimy

CONTACT

+201032062360; ahmedelshimy186@gmail.com

Mohamad Ibrahim Ahmed

CONTACT

+201014503088; Mohamadibrahimahmed2017@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 1, 2022
• Study Start: August 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07