Phase 2a Study of Antithrombotic Medicine APAC for Safety and Dose in Patients with Blocked or Narrowed Leg Arteries and Severe Limb Blood Flow Problems Undergoing Endovascular Procedures

What this Trial Is About

Researchers are studying a new medicine called APAC, which is an antiplatelet and anticoagulant drug, to see if it can help prevent blood clots and is safe for patients with blocked or narrowed arteries in their legs, a condition known as peripheral arterial occlusive disease PAOD, and those with severely restricted blood flow threatening limb health, called chronic limb-threatening ischemia CTLI. This Phase 2a open-label study aims to find the best dose of APAC and assess its safety and tolerability in these patients. The study is sponsored by Aplagon Oy and focuses on patients with different stages of PAOD and CTLI, some undergoing procedures to restore blood flow. The study has two parts, Part A and Part B, each subdivided into two subgroups testing different doses and dosing schedules of APAC. Part A includes patients with PAOD and CTLI not undergoing procedures, with subgroups receiving either a single intravenous dose or weekly intravenous doses for four weeks. Part B includes CTLI patients undergoing endovascular revascularization, with subgroups receiving a single intra-arterial dose periprocedurally or a combination of periprocedural intra-arterial and weekly intravenous doses for four weeks. APAC dosing is compared to placebo or standard treatment. A Safety Review Committee monitors data to recommend doses and schedules for Part B based on Part A results. Participants are involved for up to 90 or 180 days, including a screening period of up to 28 days. During the study, patients have regular examinations, laboratory tests, and assessments including quality of life questionnaires, walking tests, and blood clotting measurements. Researchers monitor treatment-emergent adverse events, clinical status, blood coagulation parameters, limb events, and cardiovascular events. Follow-up includes telephone surveys to assess quality of life and ischemic symptoms up to 180 days after the first dose. The study helps evaluate the safety and best dosing regimen of APAC in these vascular conditions.

Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia