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Study of cangrelor and acetylsalicylic acid in patients with ischemic stroke requiring emergency carotid artery stenting and mechanical thrombectomy

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial focuses on patients with ischemic stroke affecting large blood vessels in the brain's anterior circulation. The condition specifically involves blockages in the intracranial carotid artery or middle cerebral artery, combined with narrowing of the neck's carotid artery that requires immediate treatment.

The study examines the use of Cangrelor, given through an intravenous line, along with acetylsalicylic acid and clopidogrel. These medications help prevent blood clots from forming. The main purpose is to evaluate if Cangrelor is safe and effective when used during procedures to remove blood clots and place stents (small mesh tubes) in narrowed arteries of stroke patients.

During the study, patients will receive treatment with these blood-thinning medications while undergoing emergency procedures to restore blood flow to the brain. The doctors will monitor how well the stents stay open and check the patients' recovery from stroke over several months. They will also carefully watch for any bleeding complications that might occur during or after the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
You will be evaluated for acute ischemic stroke with blockage in the brain's blood vessels (specifically in the carotid artery area)
Medical team will confirm if you have narrowing (stenosis) of at least 50% in the carotid artery that requires immediate treatment
Step 2
Treatment procedure initiation
You will receive cangrelor through an intravenous line (IV)
The medical team will perform two procedures:
- A mechanical thrombectomy (removal of blood clot)
- Carotid artery stenting (placement of a small tube to keep the artery open)
Step 3
Medication administration
You will receive several medications:
- Acetylsalicylic acid (blood thinner) through oral and intravenous routes
- Clopidogrel (blood thinner) taken by mouth
- Cangrelor given through IV
Step 4
24-hour follow-up
After approximately 24 hours (plus or minus 6 hours), your stent will be checked to ensure it remains properly placed and functional
Your stroke symptoms will be evaluated using a standardized scale
Step 5
Hospital stay monitoring
Your condition will be monitored for:
- Brain bleeding
- Overall bleeding risk
- Stroke severity
You will be evaluated again at discharge or on day 7, whichever comes first
Step 6
90-day follow-up
A final assessment will occur 90 days (plus or minus 14 days) after your stroke
This may be conducted by telephone to evaluate your recovery progress

Who can join the trial?

6 criteria

Must be at least 18 years old
Must have a large vessel occlusion stroke in the front part of the brain (a condition where a large blood vessel supplying the front portion of the brain is blocked)
Must have a narrowing of the carotid artery (the main blood vessel in the neck that supplies blood to the brain) that is:
- At least 50% blocked
- Located on the same side as the stroke
- Requires both mechanical removal of the blood clot and immediate placement of a stent (a small tube to keep the artery open)
- Can be either male or female

Who cannot join the trial?

15 criteria

Age under 18 years or over 85 years
Known allergic reaction to Cangrelor (the study medication) or similar drugs
Active bleeding or high risk of bleeding
Recent major surgery within the last 30 days
Blood pressure higher than 185/110 mmHg that cannot be controlled with medication
History of intracranial hemorrhage (bleeding in the brain)
Current use of blood thinners or anticoagulation medication
Severe kidney or liver disease
Pregnancy or breastfeeding
Platelet count (blood cells that help with clotting) below 100,000 per microliter
Life expectancy less than 90 days due to other medical conditions
Participation in another clinical trial within the past 30 days
Unable to provide informed consent
Severe heart failure or unstable heart condition
Blood glucose (sugar) level below 50 mg/dL or above 400 mg/dL

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Verified sites

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

Verified
Medical University Of Graz
Graz, Austria
Verified
Medizinische Universitaet Innsbruck
Innsbruck, Austria
Verified
Uniklinikum Salzburg
Salzburg, Austria

Trial locations

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Investigated drugs

Cangrelor is a fast-acting intravenous medication that helps prevent blood clots. It works by stopping platelets (small blood cells) from sticking together. In this trial, it is being studied for use during emergency procedures to treat stroke patients who have blocked blood vessels in their brain and neck arteries. The medication is given through an IV during procedures where doctors need to place stents (small mesh tubes) to open blocked arteries in the neck while also removing blood clots from brain vessels.

What is already known about the treatment

Cangrelor – An intravenous antiplatelet medication that acts as a rapid-onset, reversible P2Y12 receptor antagonist used during emergency endovascular procedures, particularly in cases of ischemic stroke with large vessel occlusion. The drug works by preventing platelet aggregation at the molecular level by directly blocking the P2Y12 receptors on platelets, which is crucial during procedures like carotid artery stenting and mechanical thrombectomy. Cangrelor belongs to the pharmacological class of adenosine diphosphate (ADP) receptor antagonists and is particularly valuable in acute settings due to its immediate onset of action and short half-life, allowing for better control during critical interventional procedures.

Investigated diseases

Ischemic Stroke with Large Vessel Occlusion - A condition where blood flow to the brain is blocked due to a clot in one of the major arteries in the front part of the brain, specifically affecting the anterior cerebral circulation. The blockage typically occurs in either the internal carotid artery or the middle cerebral artery, preventing oxygen-rich blood from reaching brain tissue. This type of stroke often occurs in combination with atherosclerotic narrowing of the carotid arteries in the neck, where fatty deposits build up and restrict blood flow. The condition develops suddenly and causes rapid loss of brain function in the affected areas. The extent of brain tissue affected depends on which specific blood vessels are blocked and how long the blockage persists.