Phase 2 Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For trial parts A1, B1, and B2 (people with more severe artery disease):

• Men between 45 and 85 years old, or women up to 85 years old who have gone through menopause (no periods for 12 months without another medical reason)
• People diagnosed with peripheral artery disease of the legs at a more advanced stage (classified as Fontaine stage III or IV), meaning they have pain at rest or tissue damage such as ulcers or gangrene
• People whose affected artery segment below the knee is at least 5 cm long, confirmed by a specialised imaging scan (confirm with trial site)
• People who have only shallow wounds on the front of the foot without signs of active infection or bone involvement (confirm with trial site)
• People who are scheduled to undergo a minimally invasive procedure to open or unblock blood vessels (endovascular intervention), provided it is not scheduled before Day 8 of the study for Part A1
• People who have had a relevant imaging scan with contrast dye within the past 3 months, with results on file
• People who have been taking a low-dose blood-thinning medication — either aspirin (up to 100 mg daily) or clopidogrel (up to 75 mg daily) — for at least 5 days before starting the trial treatment
• People who are on an appropriate cholesterol-lowering treatment, as determined by the treating doctor
• People who are willing and able to give written consent to take part in the study
• Male participants who are willing to use a condom during the study, and whose female partners of childbearing potential are willing to use a highly effective method of contraception during the treatment period (methods include hormonal contraception, intrauterine devices, tubal occlusion, vasectomised partner, or abstinence)
• Male participants who are willing to avoid donating sperm during the treatment period

For trial part A2 (people with less severe artery disease):

• Men between 45 and 85 years old, or women up to 85 years old who have gone through menopause (no periods for 12 months without another medical reason)
• People diagnosed with peripheral artery disease at an earlier stage (Fontaine stage IIa or IIb), meaning they experience leg pain when walking
• People not scheduled for a minimally invasive blood vessel procedure within 90 days of starting the trial treatment
• People with moderate to severe artery narrowing, shown by a specific blood pressure measurement at the ankle being below 0.7 (ankle-brachial index)
• People who are physically able to complete a walking test on a treadmill
• People who have been taking low-dose aspirin (up to 100 mg daily) or clopidogrel (up to 75 mg daily) for at least 5 days before starting the trial treatment
• People on appropriate cholesterol-lowering treatment, as determined by the treating doctor
• People who are willing and able to give written consent to take part
• Male participants who are willing to use a condom during the study, and whose female partners of childbearing potential are willing to use a highly effective method of contraception during the treatment period
• Male participants who are willing to avoid donating sperm during the treatment period

Who may not be able to join:

• People who have tissue damage, wounds, or gangrene affecting the heel, mid-foot, or areas involving bones, joints, or tendons at or above the ball of the foot
• People with a sudden, severe loss of blood supply to a limb (such as from a blood clot)
• People who have had, or currently have, an aneurysm (a bulge in a blood vessel)
• People where the planned blood vessel procedure would be carried out from the opposite leg using a crossover approach (Parts B1 and B2 only)
• People with a history of, or conditions associated with, increased bleeding risk — including previous bleeding in the brain, a type of stroke involving bleeding, a blood-clotting stroke, stomach or intestinal bleeding within the past 6 months, bleeding behind the abdominal organs at any time, or inherited or acquired bleeding disorders such as haemophilia or von Willebrand disease
• People currently taking full therapeutic doses of blood-thinning medications such as warfarin, apixaban, rivaroxaban (at full dose), dabigatran, edoxaban, fondaparinux, or any form of heparin (note: low-dose rivaroxaban 2.5 mg combined with aspirin 100 mg is not automatically excluded but would be paused around the time of the procedure — confirm with trial site)
• People taking two different antiplatelet medications together, such as aspirin combined with clopidogrel, ticagrelor, or prasugrel
• People diagnosed with Type 1 diabetes, a form of slowly developing autoimmune diabetes (LADA), vasculitis, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune conditions
• People with a body mass index (BMI) over 35
• People with a clinically significant active infection, as assessed by the treating doctor
• People who have taken anti-inflammatory medications (such as ibuprofen or naproxen) within 2 weeks before starting the trial treatment or who would need to use them during the treatment period
• People who have taken antidepressant medications called SSRIs (such as fluoxetine or sertraline) within 2 weeks before starting the trial or during the treatment period
• People who have taken oral glycosaminoglycans, omega-3 supplements, or related products within 28 days before starting the trial treatment
• People who have had major surgery, a serious injury, any blood vessel procedure, or an organ biopsy within the past 90 days, or who have one planned during the study
• People with uncontrolled high blood pressure (systolic above 160 mmHg or diastolic above 100 mmHg)
• People whose blood haemoglobin (red blood cell) levels fall outside the acceptable range for this study at screening (confirm specific ranges with trial site)
• People whose platelet count or white blood cell count falls outside the acceptable range at screening (confirm with trial site)
• People with certain abnormal blood clotting test results at screening (confirm with trial site)
• People with a history of a serious reaction to heparin that caused a drop in platelet count (heparin-induced thrombocytopenia)
• People with known significant liver disease, or liver enzyme levels more than 2.5 times the upper limit of normal at screening
• People with severe chronic kidney disease (kidney function classified as category 4 or 5, or very high levels of protein in the urine)
• People with an active cancer, or who have received cancer treatment (including bone marrow transplant) within the past 5 years — except for certain fully treated skin cancers resolved at least 90 days before screening
• People who have previously received the trial treatment (APAC)
• People with a known allergy or serious sensitivity to heparin, heparin-based products, APAC, aspirin, clopidogrel, or protamine sulphate (the reversal agent used for APAC)
• People who have taken part in another clinical drug or device trial within the past 90 days
• People who have ever received gene therapy
• People with antiphospholipid antibody syndrome or other significant inherited or acquired clotting disorders (confirm with trial site)
• People with any other illness, condition, or treatment that the treating doctor believes would make participation unsafe or interfere with the study
• People with serious other health conditions and a limited life expectancy, as assessed by the treating doctor
• People who are unable or unwilling to follow the study procedures or work with the study team
• People with a current or past history of illicit drug use, or excessive alcohol consumption (more than approximately 23–24 drinks per week for men or 12–16 drinks per week for women)

Important: Always verify eligibility with the trial site directly before applying.