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NOT YET RECRUITING
NCT07512960
PHASE3

Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization

Sponsor: Fondation Hôpital Saint-Joseph

View on ClinicalTrials.gov

Summary

Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD).Revascularization is the cornerstone of therapy to relieve ischemic pain, prevent limb loss and preserve patient autonomy. Revascularization procedures often involve below-the-knee arterial disease in CLTI population. Dual antiplatelet therapy (DAPT, with aspirin, and clopidogrel) is recommended for at least 1-month after peripheral angioplasty. However, the exact duration of this DAPT remains controversial. Angioplasty of below-the-knee arteries is often followed by a longer period of DAPT, 3-months to one-year, due to a high risk of arterial thrombosis/stenosis.It will be the first trial on duration of DAPT in patients with below-the-knee angioplasty for CLTI, the end-stage of PAD

Official title: Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization: a Randomized, Double-blind Trial PALADIN [PeripherAL Arterial DIsease Network] -DAPTCLTI

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

614

Start Date

2026-05-30

Completion Date

2030-11-30

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

Clopidogrel 75 mg/day

After inclusion and randomization at one-month, the intervention group will receive clopidogrel 75 mg/day for 11 months and the control a placebo of clopidogrel/day for 11 months

OTHER

Placebo Clopidogrel

After inclusion and randomization at one-month, the control group will receive a placebo of clopidogrel/day for 11 months