Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07832578
EARLY_PHASE1

Comparison of Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin in Chronic Limb-Threatening Ischemia

Sponsor: King Edward Medical University

View on ClinicalTrials.gov

Summary

The goal of this \*\*clinical trial\*\* is to compare the effectiveness of \*\*low-dose rivaroxaban plus aspirin versus aspirin alone\*\* in patients aged 40-70 years with \*\*chronic limb-threatening ischemia, diabetes mellitus, hypertension, and hypercholesterolemia\*\*. The main questions it aims to answer are: * Does low-dose rivaroxaban plus aspirin reduce \*\*major adverse limb events (MALE)\*\*, such as acute limb ischemia and amputation? * Does the combination therapy reduce \*\*major adverse cardiovascular events (MACE)\*\*, such as myocardial infarction and stroke, and improve limb-related outcomes? Researchers will compare \*\*low-dose rivaroxaban (2.5 mg twice daily) plus aspirin (75-100 mg daily)\*\* with \*\*aspirin alone\*\* to see if combination therapy provides better outcomes over a period of \*\*6 months\*\*. Participants will: * Undergo baseline clinical assessment, blood tests, ABPI/TBI, and Doppler/duplex assessment. * Be randomly assigned to either the rivaroxaban plus aspirin group or the aspirin-alone group. * Attend follow-up visits at specified intervals for assessment of \*\*WIFI score, ABPI, wound healing, MALE, MACE, and quality of life\*\*. * Be assessed for treatment compliance, side effects, and bleeding during follow-up.

Official title: Comparison of Outcomes of Chronic Limb Threatening Ischemia in Diabetic and Hypertensive Patients With Hypercholesterolemia: Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin, in Mayo Hospital, Lahore

Key Details

Gender

All

Age Range

40 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-06-01

Completion Date

2027-04-01

Last Updated

2026-09-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Aspirin tablet

75 mg once daily

DRUG

Low-Dose Rivaroxaban Plus Aspirin,

Low dose Rivaroxaban 2.5 mg used orally twice a day in combination with Aspirin is a vascular protective dose as described in COMPASS and VOYEGAR PAD trials. This low dose has antithrombotic effect without full anticoagulation ,thus less bleeding risk compared to standard anticoagulant dose.

Locations (1)

Mayo Hospital Lahore

Lahore, Punjab Province, Pakistan