NCT07512960

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 614 (estimated)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Detailed description

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). This condition is associated with increased risk of mortality and major amputation and has become a global health problem. 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. Despite limb salvage procedure, recent reports still highlight the poor survival in this population. Mortality rate remains high, up to 25% of patients during the first year of follow-up after endovascular revascularization procedure. This poor overall survival isconstantly underlined in literature, with cardiovascular events as the main cause of death, followed by limb adverse events. 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. Current European or American guidelines are inconsistent concerning antithrombotic strategies after below-the knee revascularization. Most of the current antithrombotic strategy after PAD angioplasty is mainly extrapolated from coronary artery strategy. There is no randomized study after PAD revascularization in CLTI assessing the duration of DAPT. In the recent VOYAGER PAD study only 6.2% of the patients had a below-the-knee revascularization. Antithrombotic management following below-the-knee revascularization procedure is thus challenging in everyday practice. Almost invariably, longer exposure to DAPT would lead to more bleeding, and the precise risk-to-benefit ratio can hardly be codified. We considered of paramount importance to adequately study the duration of DAPT in the most severe field of PAD. The design of PALADIN-DAPTCLTI, a randomized double-blind trial, will allow to assess the potential benefit of 12 months DAPT in patients with below-the-knee angioplasty and will carefully assess the safety of this strategy. It will be the first trial on duration of DAPT in patients with below-the-knee angioplasty for CLTI, the end-stage of PAD. Furthermore, despite limb salvage, patients with CLTI do not always experience sustained gain in their quality of life and repeat procedures likely adversely affect their health status. Along with other clinical endpoints and long-term cost effectiveness, patient-reported outcome in terms of quality of life in the post-procedural period will also be particularly relevant.

Conditions

• CLTI Defined as Rutherford Category 4 or 5

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-05-30
• Primary completion: 2030-05-30
• Completion: 2030-11-30
• First posted: 2026-04-06
• Last updated: 2026-04-06