lactose monohydrate for Peripheral arterial disease (PAD)

Inclusion criteria

• {"criterion_text":"- Lesions of the iliac, femoropopliteal, and/or below-the-knee (BTK) arteries;\n- At least one TASC lesion;\n- Rutherford (1-6) classes with an indication for an endovascular intervention\n- Proficient understanding of the consequences of enrolment by the patient\n- Written informed consent by the patient;\n- Age ≥ 45 years\n- And eligibility of lesions for; 1. Percutaneous transluminal angioplasty (PTA) or recanalization with or without additional stenting based on prevailing guidelines, or; 2. Hybrid procedure with an endarterectomy of the common femoral artery and additional iliac, femoral or tibial PTA, or; 3. A reintervention within 2 months due to a phased treatment."}

Exclusion criteria

• {"criterion_text":"- Acute (limb) ischemia\n- Patients who are pregnant/contemplating pregnancy/nursing.\n- Patients requiring dialysis\n- Patients with liver failure and at least one of the following criteria; 1. elevated INR value, or; 2. portal hypertension, or; 3. thrombocytopenia <50x10^9/L, or; 4. INR, portal tension, or platelet count are unknown.\n- Reported intolerance or hypersensitivity to the study medications\n- Use of anticoagulant therapy (DOACs or coumarin)\n- Use of non-steroidal anti-inflammatory drugs >2 weeks which cannot be discontinued\n- Patients incompetent of understanding the consequences of enrolment in the trial\n- Patients with a reintervention due to restenosis/reocclusion within 2 months\n- Patients with a hybrid procedure other than endarterectomy of the common femoral artery such as femoral bypass\n- Patients with coagulopathy\n- Patients with a peptic ulcer confirmed by an esophagogastroduodenoscopy in their medical history"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is all-cause death and the occurence of cardiovascular adverse events after 1 year: (indication for) re-intervention due to any restenosis or re-occlusion or due to acute limb ischemia, the occurence of any amputation, cerebrovascular event, myocardial infarction, or cardiovascular death.","definition_or_measurement_approach":"Composite of all-cause death and cardiovascular adverse events at 1 year, including (indication for) re-intervention due to any restenosis or re-occlusion or due to acute limb ischemia, occurrence of any amputation, cerebrovascular event, myocardial infarction, or cardiovascular death."}

Secondary endpoints

• {"endpoint_text":"- The secondary endpoint is the occurence of all and major bleeding (following the TIMI bleeding classification and BARC criteria), major adverse cardiovascular events (MACE), and major adverse limb events (MALE). CYP2C19 polymorphisms will be determined to examine if non-responsiveness to clopidogrel predicts outcome.","definition_or_measurement_approach":"Occurrence of all and major bleeding assessed using TIMI bleeding classification and BARC criteria (and ISTH where specified), MACE and MALE occurrence; CYP2C19 polymorphisms assessed to evaluate clopidogrel responsiveness as a predictor of outcome."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-07-2024

Latest Decision Or Authorization Date

14-08-2025

Processing Time Days

394

Number Of Sites

19

Number Of Participants

1696

Primary sponsor

Full Name

Universitair Medisch Centrum Utrecht

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"ZonMW","duties_or_roles":"Funding (source of monetary support)","organisation_type":""}