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

Early Phase 1

• Conditions: PAD - Peripheral Arterial Disease; Combined Anticoagulation and Antithrombotic Therapy
• Interventions: Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]

• Registration Number: NCT04994223
• Lead Sponsor: Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi

Brief Summary

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

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 Timeline

• Study Start: 2021-07-02
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-06
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-03
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B( antithrombotic therapy alone group)	Rivaroxaban 10 MG Oral Tablet [Xarelto]	group B patients would be those receiving traditional antithrombotic therapy as usually given n Peripheral Arterial Disease.
Group A(combined anticoagulation plus antithrombotic therapy group)	Rivaroxaban 10 MG Oral Tablet [Xarelto]	group A patients would be receiving rivaroxaban and aspirin as experimental group to see the efficacy of rivaroxaban in peripheral arterial disease.

Primary Outcome Measures

Name	Time	Method
cardiovascular death	upto 1 year	death because of cardiovascular events
ALI	upto 1 year	acute limb ischemia
major amputation for vascular reasons	upto 1 year	any type of major amputation after revascularivation for PAD
MI	upto 1 year	myocardial infarction
ischemic stroke	upto 1 year	ischemic stroke

Secondary Outcome Measures

Name	Time	Method
thrombolysis in myocardial infarction(TIMI)major bleeding	2, 30, 180 and 365 days	combined therapy effect may result in increased bleeding tendency

Trial Locations

Locations (1)

Combined Military Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan