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

Study acronym: DAPTCLTI
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of May 30, 2026 to Jun 12, 2026
    v3
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07512960
Lead Sponsor Fondation Hôpital Saint-Joseph
Conditions
(from sponsor)		 CLTI Defined as Rutherford Category 4 or 5
Related terms Thrombosis
Enrollment 614 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov