Actively Recruiting
Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia
Led by Aplagon Oy · Updated on 2026-04-09
42
Participants Needed
3
Research Sites
73 weeks
Total Duration
On this page
Sponsors
A
Aplagon Oy
Lead Sponsor
L
LINK Medical Research AB
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males aged 45-85 years and postmenopausal females up to 85 years
- Diagnosed with PAOD Fontaine stage III or IV or CTLI with treatment-targeted arterial segment 2 5 cm below the knee lesion(s) (Parts B1 and B2)
- Superficial forefoot wounds without overt infection and bone invasion allowed
- Undergoing endovascular intervention (except Part A1 if intervention before Day 8 visit)
- Recent CTA/MRA/DSA with contrast agent within 3 months prior to enrolment
- Treated with antithrombotic medication (aspirin up to 100 mg QD or clopidogrel up to 75 mg QD) for at least 5 days before first APAC dose
- Adequate lipid lowering therapy as evaluated by investigator
- Willing and able to provide written informed consent
- Males willing to use condoms and female partners of childbearing potential willing to use highly effective contraception
- Males must refrain from sperm donation during study
- For Part A2: diagnosed with PAOD Fontaine stage IIa and IIb, not prescheduled for endovascular revascularization within 90 days
- Moderate to severe arterial disease with ABI less than 0.7
- Capable of performing evaluable treadmill exercise test
- Same medication, lipid therapy, consent, and contraception requirements as above
You will not qualify if you...
- Ischemic lesions of heel and midfoot or wounds/gangrene invading bones, joints, or tendons at or above metatarsophalangeal joints
- Acute limb-threatening ischemia such as thromboembolic disease
- History or presence of aneurysm
- Endovascular revascularization by contralateral side using cross-over access (Parts B1 and B2)
- History or condition causing impaired hemostasis or increased bleeding risk (e.g., intracranial hemorrhage, gastrointestinal bleeding, bleeding disorders)
- Current therapeutic anticoagulation use for any medical reason (except dual pathway inhibition temporarily halted on intervention days)
- Treatment with combined antiplatelet agents (aspirin plus P2Y12 antagonists)
- Autoimmune diabetes, vasculitis, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases
- Body mass index over 35 kg/m2
- Significant acute infection
- Use of NSAIDs within 2 weeks before first APAC dose or during treatment (except paracetamol or tramadol for pain)
- Use of SSRI medications within 2 weeks before first APAC dose or during treatment
- Use of oral glycosaminoglycans, omega 3, or related products within 28 days before treatment
- Major surgery, trauma, or endovascular intervention within past 90 days or scheduled during study
- Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
- Abnormal blood hemoglobin, platelet, leukocyte counts outside specified ranges
- Abnormal blood coagulation test results (PT, APTT)
- History of heparin-induced thrombocytopenia
- Known significant liver disease with elevated liver enzymes
- Severe chronic kidney disease (eGFR <30 mL/min/1.73 m2) or albuminuria stage A3
- Active malignancy or recent cancer treatment except cured localized skin cancer
- Previous treatment with APAC
- Allergy or hypersensitivity to heparin, APAC, antiplatelet agents, or reversal agent protamine sulphate
- Participation in another investigational drug or device study within 90 days
- Previous gene therapy treatment
- Known significant thrombophilia or antiphospholipid antibody syndrome
- Any condition or treatment interfering with study conduct or posing unacceptable risk
- Severe comorbidities with limited life expectancy
- Unable or unwilling to comply with study protocol
- Current or past drug or alcohol abuse exceeding defined limits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Helsinki University Hospital
Helsinki, Finland, 00290
Actively Recruiting
2
Tampere University Hospital
Tampere, Finland
Actively Recruiting
3
Turku University Hospital
Turku, Finland
Actively Recruiting
Research Team
J
Jarna Hannukainen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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