Clopidogrel Aspirin Therapy (CAT) Versus Apixiban Aspirin Therapy (AAT) After Lower Limb Revascularization

NCT04168398 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: R.19.06.544.R1 - 2019/07/03
• Study Type: interventional
• Target: 1,536
• Locations: 1 country
• Sites: 1

Brief Summary

the Aim of the work is to compare the effect of CAT (Clopidogrel aspirin therapy) and AAT (Apixiban aspirin therapy) after lower extremity revascularization. The study will be conducted at the department of vascular surgery in Mansoura university hospitals in a randomized controlled Prospective study over 2 years: 2019-2021. It will include all patients presented to our department fulfilling the ,We revascularize about 5-10 limbs per week and the study will be carried over 30 months; sample size will be 600-1200 patients,The study will be conducted in patients with lower limb ischemia who need revascularization. All Symptomatic peripheral artery disease according to Rutherford stages 3 to 6; will be included Patients with severe groin or limb infection, can't give consent (unconscious) and those with mental or behavioral disorders; will be excluded. Therapies:CAT (Clopidogrel aspirin therapy) Clopidogrel 75 mg (Plavix 75mg) plus Aspirin 81 mg. AAT (Apixiban aspirin therapy): Apixiban 2.5 twice daily (Eliquis 2.5mg) plus Aspirin 81 mg. Every patient will be followed every week till first month, then every 3 months till 1 years. Hemodynamic improvement was assessed by ankle brachial pressure index (ABI), performed before and after the procedure and every 3 months. Evaluation made by CTA or duplex ultrasonography to determine 1ry and 2ry patency, Coagulation profile (platelet count, INR, prothrombin time and activated partial thromboplastin time). Adverse bleeding complications will be documented

Conditions

Ischemia; Anticoagulants

Keywords

Clopidogrel, Apixiban and Lower Limb Revascularization

Outcome Measures

Primary Outcomes (1)

• Major adverse limb events (MALES);

  * Endovascular or surgical revascularization * Acute vessel thrombosis, * Amputation of the target limb

  two year

Secondary Outcomes (1)

• Major adverse cardiovascular events (MACE);

  two year

Study Arms (2)

Plavix 75mg and juspirin 81 mg therapy

EXPERIMENTAL

Clopidogrel 75 mg (Plavix 75mg) plus Aspirin (juspirin) 81 mg.

Drug: Combination drug

Eliquis 2.5mg and juspirin 81 mg therapy):

EXPERIMENTAL

Apixiban 2.5 twice daily (Eliquis 2.5mg) plus Aspirin (juspirin) 81 mg.

Drug: Combination drug

Interventions

Combination drug DRUG

Anticoagulation

Also known as: anticoagulations plus antiplatelets

Eliquis 2.5mg and juspirin 81 mg therapy):; Plavix 75mg and juspirin 81 mg therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic peripheral artery disease according to Rutherford stages 3 to 6.

You may not qualify if:

• Patients with severe groin or limb infection.
• who can't give consent (unconscious)
• Those with mental or behavioral disorders will be excluded.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura

Al Mansurah, Mansoura University, 35111, Egypt

Location

MeSH Terms

Conditions

Ischemia

Interventions

Drug Combinations

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Nshaat A Elsaadany, MSc

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Block randomization: Two elements A for CAT, B for AAT A A B B A B A B A B B A B B A A B A B A B A A B
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled Prospective study: It will include all patients presented to our department fulfilling the inclusion criteria. We revascularize about 5-10 limbs per week and the study will be carried over 30 months; sample size will be 600-1200 patients

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 19, 2019
• Study Start: July 3, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 3, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

EG (1)