Early Phase 1 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 patients with peripheral artery disease (PAD):

• Men and women between 40 and 85 years old.
• People diagnosed with peripheral artery disease (reduced blood flow in the limbs) at certain severity levels, including some with minor wounds on the feet or legs.
• People whose kidneys are functioning above a certain minimum level, based on a standard blood test result (confirm with trial site).
• People who have had a CT scan with contrast dye of their blood vessels within the past 3 months, with results available in their medical records.
• People who have not had surgery or a procedure to treat their artery disease within the past year, and do not have one planned before the study ends.
• People who are able to give informed consent and communicate clearly with the research team.
• Women who have not yet reached menopause must be willing to use highly effective birth control for 195 days after receiving the study drug.
• Men must be willing to use highly effective birth control, including condoms for the first 15 days, for 105 days after receiving the study drug, to avoid passing the study substance to a partner who could become pregnant.
• People who can understand all study information provided in Dutch.

For healthy volunteers:

• Men and women between 40 and 80 years old.
• People who are in good health, with no active or chronic illness, confirmed through medical history, physical examination, heart tracing (ECG), and blood and urine tests.
• People with no diagnosis of diabetes, pre-diabetes, or insulin resistance.
• People with normal kidney function based on a standard blood test.
• Women who have not yet reached menopause must be willing to use highly effective birth control for 195 days after receiving the study drug.
• Men must be willing to use highly effective birth control, including condoms for the first 15 days, for 105 days after receiving the study drug, to avoid passing the study substance to a partner who could become pregnant.
• People who can understand all study information provided in Dutch.

Who may not be able to join:

For patients with peripheral artery disease (PAD):

• People experiencing a sudden, severe loss of blood supply to a limb (such as from a blood clot).
• People who have an aneurysm (a bulge in a blood vessel) that needs surgery.
• People with a personal or family history of bleeding problems, including previous brain bleeds, strokes involving bleeding, gut or internal bleeding, or inherited bleeding disorders such as haemophilia or von Willebrand disease.
• People who have had a stroke, mini-stroke (TIA), or similar event in the past year.
• People diagnosed with Type 1 diabetes or a form called latent autoimmune diabetes in adults (LADA).
• People whose blood sugar control (HbA1c) is above 10% at the screening visit.
• People currently taking blood-thinning medications such as warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, fondaparinux, or any heparin-based medicine.
• People taking two or more antiplatelet medicines at the same time (a single low-dose aspirin up to 100 mg daily, or clopidogrel up to 75 mg daily, may be acceptable — confirm with trial site).
• People who have used anti-inflammatory painkillers (such as ibuprofen or naproxen) within 2 weeks before receiving the study drug (paracetamol may be used for pain relief instead).
• People who have used antidepressants known as SSRIs within 2 weeks before receiving the study drug.
• People who have had major surgery, serious injury, or any procedure involving blood vessels in the past 90 days, or a tissue biopsy or diagnostic scan of blood vessels in the past 30 days.
• People with blood pressure that is consistently very high (above 160/100 mmHg) and not controlled by treatment.
• People whose blood count results at screening fall outside certain minimum levels for red blood cells or platelets, or whose white blood cell count is above a certain level (confirm with trial site).
• People whose blood clotting time is significantly abnormal on testing.
• People with a history of a serious reaction to heparin that caused a drop in platelets (heparin-induced thrombocytopenia).
• People with known significant liver disease, or liver enzyme levels above a certain threshold on blood testing.
• People with severely reduced kidney function combined with a high level of protein in the urine (confirm with trial site).
• People who currently have cancer, or who have received cancer treatment within the past year — except for certain minor skin cancers that were fully treated at least 90 days before screening.
• People with a history of cancer that has spread to other parts of the body.
• People who are pregnant or breastfeeding.
• People with a known allergy or sensitivity to heparin or heparin-related products, aspirin, or clopidogrel.
• People who have taken part in another clinical trial of a drug or medical device within the past 30 days.
• People who have previously received treatment with an antibody therapy or gene therapy (unless there is evidence they only received a placebo).
• People with a condition called antiphospholipid antibody syndrome or another inherited or acquired clotting disorder.
• People with a history of severe infection or inflammation of blood vessels linked to an autoimmune condition, or who have inflammatory bowel disease or Crohn's disease.
• People with any other illness or condition that the trial doctors believe would make participation unsafe or interfere with the study.
• People who are unwilling or unable to follow the study procedures or work cooperatively with the research team.
• People with a history of illicit drug use, or of regularly drinking more than 4 alcoholic drinks per day, in the past 12 months.

For healthy volunteers:

• People who have any signs or symptoms of peripheral artery disease or other heart or blood vessel conditions.
• People with an abnormal ankle-brachial index (a test comparing blood pressure in the ankle and arm, used to check blood flow) at rest or after walking on a treadmill.
• People who have used any blood-thinning or antiplatelet medication (other than standard-dose aspirin) in the past 12 months.
• People who regularly take any prescription or over-the-counter medication, except for vitamins.
• People with a history of a serious reaction to heparin that caused a drop in platelets.
• People with a history of atrial fibrillation (an irregular heart rhythm) or who have a mechanical heart valve.
• People who have had major surgery, serious injury, or a tissue biopsy in the past 90 days.
• People with a history of, or any condition associated with, an increased risk of bleeding.
• People with blood pressure above 140/90 mmHg.
• People with a history of, or currently having, an aneurysm (a bulge in a blood vessel).
• People whose blood count results at screening fall outside certain minimum levels for red blood cells or platelets, or whose white blood cell count is above a certain level (confirm with trial site).
• People whose blood clotting time is significantly abnormal on testing.
• People who have taken part in another clinical trial of a drug or medical device within the past 30 days.
• People who have previously received treatment with an antibody therapy or gene therapy (unless there is evidence they only received a placebo).
• People with a known clotting disorder (thrombophilia).
• People who are pregnant or breastfeeding.
• People who are unwilling or unable to follow the study procedures or work cooperatively with the research team.
• People with a history of illicit drug use, or of regularly drinking more than 4 alcoholic drinks per day, in the past 3 months.

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