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

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What is this study about?

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.

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)

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

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

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

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 Study?

  • 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
  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Turku University Hospital Turku Finland
Pirkanmaan hyvinvointialue Tampere Finland
Hcbpwoht Udkpdbxzza Cykrkpd Hcyeoots Helsinki Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Recruiting
15.09.2025

Trial locations

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.

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.

Trial ID:
2025-522390-11-00
Protocol code:
APLA-PAOD-CS02
Trial Phase:
Therapeutic exploratory (Phase II)

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