Recruiting

Study of APAC (antiplatelet, anticoagulant) treatment in patients with peripheral arterial disease and chronic limb-threatening ischemia during blood vessel restoration procedure

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia, conditions that cause reduced blood flow to the legs. The study tests a new medication called APAC, which combines properties of blood thinning and anti-clotting medicines. The treatment is given through intravenous administration, meaning it is delivered directly into the bloodstream.

The study aims to evaluate how safe and well-tolerated APAC is when given to patients, particularly those undergoing procedures to restore blood flow to their legs. During the study, some patients will receive APAC as a single dose, while others will receive weekly doses. The medication will be used alongside standard blood-thinning medicines such as acetylsalicylic acid or clopidogrel. Sodium chloride solution and heparin will also be used during the treatment.

Throughout the study, patients will undergo various health checks including physical examinations, blood tests, and measurements of blood flow in their legs. The study will monitor how well patients can walk and assess their quality of life. Doctors will also check for any side effects, particularly focusing on any bleeding events that might occur during the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your medical condition will be confirmed: peripheral arterial occlusive disease (PAOD) or chronic limb-threatening ischemia (CLTI)
A scan of your blood vessels (CTA/MRA/DSA) must be available from the last 3 months
Your current medications will be reviewed, including blood-thinning medication (acetylsalicylic acid up to 100 mg daily or clopidogrel up to 75 mg daily)
Step 2
Treatment phase - Part A1
You will receive APAC through an intravenous line (directly into your vein)
Single infusion followed by weekly dosing
Monitoring period: 29 days from first dose
Regular checks will include physical examination, vital signs, and blood tests
Step 3
Treatment phase - Part A2
Weekly APAC administration through intravenous line
Monitoring period: 90 days from first dose
Additional tests include walking ability on a treadmill
Regular measurement of blood pressure in arms and legs
Step 4
Treatment phase - Part B
APAC administration during blood vessel procedure and weekly thereafter
Monitoring period: 90 days from first dose
Regular assessment of wound healing and blood flow in legs
Monitoring of any bleeding events or surgical complications
Step 5
Follow-up evaluations
Regular assessment of pain levels using a scale
Quality of life questionnaires
Physical performance evaluations
Monitoring of any heart or leg-related complications

Who can join the trial?

11 criteria

Age requirements: Men between 45-85 years old and postmenopausal women (no menstrual periods for 12 months naturally) up to 85 years old
Must have severe leg artery disease with an ankle-brachial index (blood pressure measurement in ankle compared to arm) less than 0.7
Must have had special blood vessel imaging (CTA, MRA, or DSA) within the last 3 months before joining the study
Must be taking blood-thinning medication (either aspirin up to 100 mg daily or clopidogrel up to 75 mg daily) for at least 5 days before starting treatment
Must be on appropriate cholesterol-lowering medication as determined by the doctor
Must be able to perform a walking test on a treadmill
Must be willing and able to provide written consent to participate in the study
check
For male participants:
- Must agree to use condoms during the study
- Must not donate sperm during the study
- If having female partners who can become pregnant, those partners must use effective birth control methods
- For women: Must be post-menopausal (no menstrual periods for at least 12 months naturally)

Who cannot join the trial?

14 criteria

History of severe allergic reactions or hypersensitivity to medications
Active or recent major bleeding within the past 3 months
Significant kidney problems (severe renal impairment)
Severe liver disease or abnormal liver function
Blood clotting disorders or currently taking blood thinning medications
Active cancer or ongoing cancer treatment
Recent heart attack or stroke within the past 6 months
Uncontrolled high blood pressure (hypertension)
Pregnancy or breastfeeding
Participation in another clinical trial within the past 30 days
History of drug or alcohol abuse within the past year
Presence of acute infections or ongoing inflammatory conditions
Mental health conditions that could affect ability to provide informed consent
Life expectancy less than 6 months due to other medical conditions

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Helsinki University Central Hospital
Helsinki, Finland
Verified
Pirkanmaan hyvinvointialue
Tampere, Finland
Verified
Turku University Hospital
Turku, Finland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

APAC (antiplatelet, anticoagulant) is a heparin proteoglycan mimetic medication that works as both an antiplatelet and anticoagulant agent. It is designed to prevent blood clots and improve blood flow. In this trial, it is being tested in patients who have peripheral arterial occlusive disease and chronic limb-threatening ischemia, conditions where arteries in the limbs become blocked. The medication is administered both intravenously (through a vein) and intra-arterially (directly into an artery) during endovascular procedures to help restore blood flow to affected limbs.

What is already known about the treatment

APAC (Antiplatelet, Anticoagulant) - A novel heparin proteoglycan mimetic that is administered through both intravenous (i.v.) and intra-arterial (i.a.) routes during endovascular procedures. This investigational drug is currently being studied in phase 2a clinical trials for patients with peripheral arterial occlusive disease (PAOD) and chronic limb-threatening ischemia (CLTI). APAC functions as a dual antiplatelet and anticoagulant agent, designed to prevent blood clotting during vascular procedures and potentially improve outcomes in patients undergoing endovascular revascularization. The medication represents a new approach in vascular medicine, combining the properties of traditional antithrombotic agents in a single compound that mimics natural proteoglycans found in blood vessels.

Investigated diseases

Peripheral arterial occlusive disease (PAOD)
A circulatory condition where narrowed arteries reduce blood flow to the limbs, most commonly affecting the legs. The condition develops gradually as arteries become hardened and narrowed due to the buildup of fatty deposits on vessel walls. This progressive disease causes reduced blood flow to affected limbs, leading to decreased oxygen delivery to tissues. Symptoms typically begin with leg pain during physical activity, known as intermittent claudication. As the disease advances, patients may experience pain even at rest and develop tissue changes in their feet or legs.
Chronic limb-threatening ischemia (CLTI)
A severe form of peripheral artery disease characterized by severely reduced blood flow to the lower extremities. The condition results in chronic pain in the feet or toes, even while resting. CLTI causes inadequate blood supply to meet the metabolic demands of the affected limb during rest. The reduced circulation often leads to the development of wounds that heal poorly or not at all. This condition represents an advanced stage of vascular disease where tissues receive critically low levels of oxygen and nutrients.