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

ConditionCLTI Defined as Rutherford Category 4 or 5

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-99

SponsorFondation Hôpital Saint-Joseph

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Hospitalized patients with CLTI defined as Rutherford category 4 (ischemic rest pain) or 5 (minor tissue loss, non-healing ulcer, focal gangrene) evolving for > 2 weeks + one or more abnormal hemodynamic parameters: ankle-brachial index (ABI) <0.4 (using higher of the dorsalis pedis and posterior tibial arteries), absolute highest ankle pressure <50 mm Hg, absolute toe pressure <30 mm Hg.

Successful endovascular revascularization involving below-the-knee arteries (angioplasty/stenting) alone or combining above- and below-the-knee revascularization within the last 7 days prior to randomization

Affiliation to a French Health Insurance system

Disqualifiers

PAD Rutherford category 0, 1, 2, 3 or 6 (Rutherford 6 defined as severe

ischemic ulcers or foot gangrene exceeding the digits)

Acute limb ischemia within one month prior to the qualifying revascularization

Platelet count < 100x109/L

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

614 Participants

are divided into 2 treatment groups

Group A: CLOPIDOGRELExperimental treatment 1 intervention

Group B: PLACEBO CLOPIDOGRELPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Amputation-free survival at 12 months

Amputation-free survival at 12 months, defined as time from randomization until major amputation (defined as above-the-ankle amputation) or death from any cause, whichever occurs first, for all subjects.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondation Hôpital Saint-Joseph

Lead sponsor

Source ClinicalTrials.gov

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