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

Summary

The goal of this study is to learn if a new medicine (called antiplatelet and anticoagulant \[APAC\]) can help the body to prevent blood clots and whether APAC is safe and well tolerated in patients with blocked or narrowed arteries in their legs (peripheral arterial occlusive disease \[PAOD\]), and in patients with severely restricted poor blood flow to the legs that threatens limb health (chronic limb-threatening ischemia \[CTLI\]). The study also aims to find the best dose of the medicine. The study consists of two parts: Part A will include patients with PAOD and CTLI, Part B will only include patients with CTLI who are having a procedure to restore blood flow in their legs. Both parts will be subdivided into two subgroups (A1 and A2, B1 and B2) which will test different APAC doses and compare single dosing to weekly dosing for 4 weeks. APAC is injected into the blood. The possible treatment response will be compared either to a placebo (a look-alike substance that contains no drug), or to the current standard treatment. Patients will participate in the study for up to 90 or 180 days. During this time, patients will be regularly examined and asked to answer questions concerning their quality of life.

Conditions

• Peripheral Arterial Occlusive Disease
• Chronic Limb-Threatening Ischemia

Interventions

DRUG

APAC - dose level 0.50 mg/kg,

single i.v. dosing

OTHER

Unfractionated heparin (UFH)

administered as standard of care

DRUG

APAC dose level 1: 0.25 mg/kg,

weekly i.v. dosing for 4 consecutive weeks

OTHER

Vehicle (sterile saline, NaCL 0.9%)

weekly i.v. dosing for 4 consecutive weeks

DRUG

APAC dose level 2: 0.50 mg/kg,

weekly i.v. dosing for 4 consecutive weeks

DRUG

APAC (single periprocedural dose)

Dose is selected based on Part A data, periprocedural dosing.

DRUG

APAC

Dose is selected based on Part A and Part B, periprocedural dosing plus dosing for 4 consecutive weeks.

Sponsors & Collaborators

• LINK Medical Research AB

  collaborator UNKNOWN

• Estimates OY

  collaborator UNKNOWN

• Aplagon Oy

  lead INDUSTRY

Principal Investigators

• Jarna Hannukainen · Aplagon Oy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-29

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• Finland

Study Locations