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

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

Study Overview

• Status: Recruiting
• Conditions: PAD - Peripheral Arterial Disease; Combined Anticoagulation and Antithrombotic Therapy
• Intervention / Treatment: Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ayesha masood, MBBS, FCPS Surgery; Phone Number: +923059159699; Email: laparoscopy.6@gmail.com
• Study Contact Backup: Name: Muhammad Irfan, MBBS,FCPS Surgery,; Phone Number: +923339259643; Email: irfan1373@yahoo.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Recruiting
      • Combined Military Hospital
      • Contact: muhammad jamil, MBBS, FCPS General Surgery; Phone Number: +923216409020
      • Contact: muhammad irfan, MBBS,FCPS Surgery; Phone Number: +923339259643; Email: irfan1373@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- all patients with PAD candidates for revascularization procedures

Exclusion Criteria:

1. planned long-term dual antiplatelet therapy (>6 months),
2. clinical requirement for therapeutic anticoagulation,
3. recent acute limb ischemia or acute coronary syndrome,
4. 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),
5. any documented history of intracranial hemorrhage, stroke, or transient ischemic attack

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A(combined anticoagulation plus antithrombotic therapy group); 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]; rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival
Active Comparator: Group B( antithrombotic therapy alone group); group B patients would be those receiving traditional antithrombotic therapy as usually given n Peripheral Arterial Disease.	Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]; rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: rivaroxaban in PAD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: PAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: title
• IPD Sharing Time Frame: 6 months from start of study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No