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Tests treatment safety and results for Peripheral Arterial Occlusive Disease
Official title Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia
ClinicalTrials.gov ID: NCT07352800
What this study is testing
What is APAC - dose level 0.50 mg/kg,?
APAC - dose level 0.50 mg/kg, is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for peripheral arterial occlusive disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 85
You may be able to join if
- (Parts A1, B1 and B2):
- Males aged 45-85 years and postmenopausal females (i.e., no menstrual periods for 12 months without an alternative medical cause) up to 85 years.
- Diagnosed with a. PAOD classification Fontaine stage III or IV , b. the total length of the treatment-targeted arterial segment ≥ 5 cm below the knee...
- CTA/MRA/DSA with contrast agent performed within 3 months prior to study enrolment as part of diagnostics of PAOD, with results available in the...
- Patients should be treated with antithrombotic medication either acetylsalicylic acid (up to 100 mg once a day [QD]) or clopidogrel (up to 75 mg QD)...
You likely can't join if
- Any ischemic lesions of the heel and midfoot and lesions (wounds or gangrene) invading bones, joints, or tendons at metatarsophalangeal joints or...
- Acute limb-threatening ischemia (e.g., thromboembolic disease).
- Medical history of, or an existing aneurysm.
- Endovascular revascularization intervention is done from the contralateral side using cross-over access (Part B1 and B2).
- Medical history of, or condition known to be associated with impaired hemostasis, i.e., increased intracranial bleeding risk e.g., previous history...
- Current use of therapeutic dose of anticoagulation (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, fondaparinux, or any heparin derivative)...
See the full eligibility criteria
Who can join
- (Parts A1, B1 and B2):
- Males aged 45-85 years and postmenopausal females (i.e., no menstrual periods for 12 months without an alternative medical cause) up to 85 years.
- Diagnosed with a. PAOD classification Fontaine stage III or IV , b. the total length of the treatment-targeted arterial segment ≥ 5 cm below the knee lesion(s) based on contrast-enhanced computed tomography angiography...
- CTA/MRA/DSA with contrast agent performed within 3 months prior to study enrolment as part of diagnostics of PAOD, with results available in the patient's medical records.
- Patients should be treated with antithrombotic medication either acetylsalicylic acid (up to 100 mg once a day [QD]) or clopidogrel (up to 75 mg QD) for at least the preceding five days before the first APAC...
- Adequate lipid lowering therapy, as evaluated by the investigator.
- Capability and willingness to provide valid, voluntary written informed consent for the study.
- Males must be willing to use a condom and their female partners of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile [hysterectomy, bilateral...
- Males must refrain from sperm donation while on study treatment. (Part A2):
- Males aged 45-85 years and postmenopausal females (i.e., no menstrual periods for 12 months without an alternative medical cause) up to 85 years.
- Diagnosed with a. PAOD classification Fontaine stage IIa and IIb, b. not prescheduled for endovascular revascularization within 90 days of first APAC administration.
- Moderate to severe arterial disease, ABI \< 0.7.
- Patients should be capable of performing evaluable treadmill exercise test.
- Patients should be treated with antithrombotic medication either acetylsalicylic acid (up to 100 mg QD) or clopidogrel (up to 75 mg QD) for at least the preceding five days before the first APAC administration.
- Adequate lipid lowering therapy, as evaluated by the investigator.
- Capability and willingness to provide valid, voluntary written informed consent for the study.
- Males must be willing to use a condom and their female partners of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile [hysterectomy, bilateral...
- Males must refrain from sperm donation while on study treatment.
What rules you out
- Any ischemic lesions of the heel and midfoot and lesions (wounds or gangrene) invading bones, joints, or tendons at metatarsophalangeal joints or more proximal sites.
- Acute limb-threatening ischemia (e.g., thromboembolic disease).
- Medical history of, or an existing aneurysm.
- Endovascular revascularization intervention is done from the contralateral side using cross-over access (Part B1 and B2).
- Medical history of, or condition known to be associated with impaired hemostasis, i.e., increased intracranial bleeding risk e.g., previous history of intracranial hemorrhage, subarachnoidal bleeding, hemorrhagic...
- Current use of therapeutic dose of anticoagulation (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, fondaparinux, or any heparin derivative) for any medical reason. (Use of dual pathway inhibition [=...
- Patients treated with combined antiplatelet agents: aspirin + P2Y12 antagonist (clopidogrel, ticagrelor, prasugrel).
- Diagnosis of autoimmune diabetes mellitus (Type 1 diabetes, or latent autoimmune diabetes in adults [LADA]) vasculitis, rheumatoid arthritis, inflammatory bowel diseases, or other general autoimmune diseases.
- Body mass index \> 35 kg/m\^2.
- Patients with clinically significant acute infection, as judged by the investigator.
- Use of non-steroidal anti-inflammatory medications within 2 weeks prior to the first dose of APAC or during the treatment period. If medication for pain is required, paracetamol or tramadol (e.g. an opioid patch) may be...
- Use of selective serotonin reuptake inhibitor (SSRI) medication within 2 weeks prior to the first dose of APAC or during the treatment period.
- Peroral use of glycosaminoglycans or omega 3 or related products within 28 days before IMP treatment.
- Major surgery, major trauma or any endovascular intervention within the past 90 days or organ biopsy prior to the screening visit or scheduled for such an intervention during the study.
- Uncontrolled arterial hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg).
- Blood hemoglobin concentration \ 170 g/L (men) and \ 160 g/L (women) at screening.
- Blood platelet count \ 450 x10\^9/L and/or leukocyte count in the lower reference range or not above \>12 x 10\^9/L.
- Clinically significantly prolonged plasma PT (\> 1.2-fold) or a value of less than 50% (when normal reference range is 70-130%).
- APTT above the upper limit of the reference range.
- Patients with a medical history of heparin-induced thrombocytopenia.
- Patients with known significant liver disease, incl. an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) level \> 2.5 x the upper limit of normal (ULN) at screening.
- A diagnosis of severe chronic kidney disease, defined as having an eGFR category 4 or 5 (eGFR \ 300 mg/g).
- Patients with an active malignancy, or who have received treatment for any malignancy including bone marrow transplantation within 5 years before the screening visit, except for localized basal cell or squamous cell...
- Previous treatment with APAC.
- Patients with known allergy or hypersensitivity to heparin, or heparin products, APAC, and/or antiplatelet agents (e.g., aspirin or clopidogrel), and protamine sulphate, the reversal agent for APAC.
- Participation in an investigational drug or device study within 90 days prior to screening.
- Patients who have ever received treatment with a gene therapy.
- Patients with known antiphospholipid antibody syndrome or other known significant thrombophilia (homozygosity for FV Leiden or FIIG20210A mutation, or phospholipid antibody syndrome, deficiency of antithrombin, protein...
- Any concomitant disease or condition or treatment that could interfere with, or the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study as...
- Patients with severe comorbidities and limited life expectancy as judged by the investigator.
- Patients unable or unwilling to comply with the protocol or to cooperate fully with the investigator or site personnel.
- Patients with current and/or history of drug abuse (defined as illicit drug use) or alcohol abuse (defined as daily consumption of more than 23-24 and 12-16 alcoholic drinks per week in males and females, respectively).
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Tampere, Finland
- Turku, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Tampere, Finland; Turku, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.