Actively Recruiting
Safety, Tolerability, and Dosing of APAC in Patients With Peripheral Arterial Occlusive Disease and Chronic Limb-Threatening Ischemia Undergoing Endovascular Revascularization
Led by Aplagon Oy · Updated on 2026-04-09
42
Participants Needed
3
Research Sites
N/A
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
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.
CONDITIONS
Brief 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 to 85 years and postmenopausal females up to 85 years
- Diagnosed with PAOD Fontaine stage IIa, IIb, III, or IV depending on study part
- Undergoing or not scheduled for endovascular intervention as required by study part
- Contrast-enhanced imaging (CTA, MRA, or DSA) performed within 3 months with available results
- Treated with acetylsalicylic acid (up to 100 mg daily) or clopidogrel (up to 75 mg daily) for at least 5 days before first APAC dose
- Adequate lipid-lowering therapy as evaluated by investigator
- Capability and willingness to provide written informed consent
- Males must agree to use condoms and female partners of childbearing potential must use highly effective contraception during treatment
- Males must refrain from sperm donation while on study treatment
You will not qualify if you...
- Ischemic lesions of heel and midfoot or wounds/gangrene invading bones, joints, or tendons
- Acute limb-threatening ischemia such as thromboembolic disease
- History of or existing aneurysm
- Endovascular intervention done from contralateral side using cross-over access (Parts B1 and B2)
- History or condition with impaired hemostasis or bleeding risk including recent major bleeding or inherited bleeding disorders
- Current use of therapeutic anticoagulation drugs (exceptions apply)
- Treatment with combined antiplatelet agents (aspirin + P2Y12 antagonists)
- Autoimmune diseases including Type 1 diabetes, vasculitis, rheumatoid arthritis, or inflammatory bowel diseases
- Body mass index over 35 kg/m2
- Acute infection judged clinically significant
- Use of NSAIDs or SSRIs within 2 weeks before or during treatment
- Use of glycosaminoglycans, omega 3, or related products within 28 days before treatment
- Major surgery, trauma, endovascular intervention, or biopsy within 90 days before screening or scheduled during study
- Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Abnormal blood counts or coagulation test results outside specified ranges
- History of heparin-induced thrombocytopenia
- Significant liver disease or severe chronic kidney disease
- Active malignancy or recent cancer treatment within 5 years (except certain cured skin cancers)
- Previous treatment with APAC or gene therapy
- Known allergy to heparin, APAC, antiplatelet agents, or reversal agents
- Participation in another investigational drug/device study within 90 days
- Known antiphospholipid antibody syndrome or significant thrombophilia
- Conditions or treatments that may interfere with study conduct or pose unacceptable risk
- Severe comorbidities with limited life expectancy
- Inability or unwillingness to comply with protocol or cooperate fully
- Current or history of illicit drug or alcohol abuse exceeding specified limits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks depending on dosing regimen
Participants receive APAC dosing either as a single intravenous dose, weekly intravenous doses for 4 weeks, a single intra-arterial periprocedural dose, or a combination of intra-arterial periprocedural dose and weekly intravenous doses for 4 weeks depending on their study part and randomization group.
1 to 5 visits depending on dosing schedule
Duration - Up to 180 days after first dose
Participants are monitored for safety, clinical outcomes, and quality of life after receiving APAC, with assessments continuing for up to 180 days.
Telephone surveys and in-person assessments as scheduled up to Day 180
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
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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