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

PAD - Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994223
• Other study ID #: PAD
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 2, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2022
• Source: Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
• Contact: Ayesha masood, MBBS, FCPS Surgery
• Phone: +923059159699
• Email: laparoscopy.6[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• PAD - Peripheral Arterial Disease
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Rivaroxaban 10 MG Oral Tablet [Xarelto]
rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival

Locations

Country	Name	City	State
Pakistan	Combined Military Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALI	acute limb ischemia	upto 1 year
Primary	major amputation for vascular reasons	any type of major amputation after revascularivation for PAD	upto 1 year
Primary	MI	myocardial infarction	upto 1 year
Primary	ischemic stroke	ischemic stroke	upto 1 year
Primary	cardiovascular death	death because of cardiovascular events	upto 1 year
Secondary	thrombolysis in myocardial infarction(TIMI)major bleeding	combined therapy effect may result in increased bleeding tendency	2, 30, 180 and 365 days