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Enhanced dual antiplatelet therapy with clopidogrel and acetylsalicylic acid for secondary prevention in patients with mild ischemic stroke

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

The study focuses on people who have experienced a mild stroke and are at risk for another event. After receiving clot‑breaking medicine (known as IVT) or a clot‑removing procedure (EVT), patients are evaluated with a simple scale called the NIHSS that measures neurological function; a low score indicates only minor deficits.

Participants receive a short course of dual antiplatelet therapy, which combines two medicines that keep blood platelets from forming clots. The regimen includes clopidogrel together with a low dose of acetylsalicylic acid. This combination is intended to give stronger protection against clot formation than a single agent alone.

The aim of the trial is to determine whether this intensified medication approach lowers the chance of a recurrent event. Over the following weeks, participants undergo a brain scan with MRI around day 25 to look for new lesions, including a special sequence called SWI that can detect tiny bleeding spots. Additional assessments such as the functional outcome scale mRS, a brief memory and thinking test MoCA, and safety checks for bleeding are performed during the 90‑day follow‑up 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 enrollment
After giving informed consent, you will be assigned to the study group and will begin the trial procedures.
Your medical history and the recent mild stroke will be recorded.
Step 2
Baseline imaging and testing
On day 1, a brain MRI (cMRI) will be performed to document the current condition of the brain.
Standard neurological assessments, such as the NIHSS score, will be completed.
Step 3
Start of study medication
You will begin taking two oral medicines:
clopidogrel – 300 mg per dose; acetylsalicylic acid (aspirin) – 100 mg per dose.
The exact frequency and total length of treatment will be defined by the study protocol.
Step 4
Mid‑study follow‑up
Around day 25 (plus or minus 4 days), a second brain MRI will be done to look for any new ischemic lesions.
Additional assessments will include repeat neurological scoring, a brief cognitive test (MoCA), and evaluation for any bleeding events.
Step 5
Final follow‑up
Approximately day 90 (plus or minus 7 days), you will have a final visit.
The visit will include a clinical assessment of stroke‑related disability (mRS), collection of information about any heart attacks, deaths, or bleeding complications, and a review of any adverse events.

Who can join the trial?

4 criteria

Be 18 years old or older, regardless of gender.
Have had an acute ischemic stroke (AIS) that was treated with intravenous thrombolysis (IVT) using medicines such as alteplase or tenecteplase, and/or with endovascular therapy (EVT), and have a follow‑up score of 7 or less on the National Institutes of Health Stroke Scale (NIHSS), which measures stroke severity.
Be able to take the study medication by mouth or through a thin tube placed through the nose into the stomach (nasogastric administration).
Provide written agreement (signed consent) to join the study.

Who cannot join the trial?

24 criteria

Any type of brain bleeding seen on a scan taken 12–24 hours after clot‑busting treatment (unless it is a very small bleed called HI1).
Scheduled surgery that cannot be delayed and will require stopping blood‑thinner pills (antiplatelet drugs).
Having an acute, life‑threatening stroke in the middle part of the brain (malignant MCA infarction).
A low ASPECT Score (less than 5) or a large area of damage on a special MRI scan (diffusion‑weighted imaging showing more than 50% of the middle cerebral artery territory).
Current large, dangerous brain stroke (malignant middle cerebral artery infarction).
Using medicines that strongly interact with aspirin (ASA) or clopidogrel and cannot be switched to safer alternatives.
Having a condition that makes magnetic resonance imaging (MRI) unsafe, such as a non‑MRI‑compatible pacemaker or other implants.
Known infection with HIV.
Life expectancy expected to be less than one year.
Allergy or severe reaction to aspirin (ASA), clopidogrel, their ingredients, or similar drugs.
Being enrolled in another interventional clinical trial within the past four weeks.
Having an addiction or other condition that prevents understanding or evaluating the study.
Blood test results showing INR greater than 1.5, platelet count below 100,000 per cubic millimeter, liver enzyme ALT three times higher than normal, or kidney function creatinine two times higher than normal.
Any reason to think the patient would not be able to follow the study rules.
Being pregnant or breastfeeding.
Women who could become pregnant unless they are post‑menopausal, have had surgery removing both ovaries, use reliable birth control (failure rate less than 1 % per year), are sexually abstinent, or have a partner who has had a vasectomy.
Being financially or otherwise dependent on the study sponsor, principal investigator, or study staff.
Any previous non‑traumatic bleeding inside the skull.
Major bleeding events in the past five years, including serious head injuries.
Significant non‑major bleeding within the last three months.
Needing regular blood‑thinner medication (therapeutic anticoagulation) such as phenprocoumon, heparin, apixaban, rivaroxaban, edoxaban, or dabigatran for conditions like irregular heart rhythm, artificial heart valve, or deep vein clot.
Medical reasons that forbid the use of aspirin (ASA) or clopidogrel as listed in their official product information.
Medical reasons that forbid using both antiplatelet drugs together (dual antiplatelet therapy), such as bleeding disorders.
Needing dual antiplatelet therapy for longer than 21 days.

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Verified sites

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

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Verified
Ulm, Germany
Justus-Liebig-Universitaet Giessen
Verified
Giessen, Germany

Trial locations

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Investigated drugs

CLOPIDOGREL
is a medication that helps keep blood platelets from sticking together, which reduces the chance of blood clots forming. In this study, it is given as an extra antiplatelet treatment after a mild stroke when patients have already received clot‑busting therapy. The purpose is to find out if adding clopidogrel can lower the risk of having another stroke.
ACETYLSALICYLIC ACID
(commonly known as aspirin) is a well‑known antiplatelet drug that also prevents platelets from clumping. In the trial, every participant receives aspirin as part of the usual care for stroke prevention. It serves as the background therapy against which the added effect of clopidogrel is tested.

What is already known about the treatment

CLOPIDOGREL
Clopidogrel is taken by mouth as a tablet, usually 300 mg in this study. It is an approved and well‑studied drug used to prevent new strokes and heart problems. It works by blocking a specific receptor on platelets, which stops them from clumping together and forming clots. It belongs to the class of antiplatelet medicines.
ACETYLSALICYLIC ACID
Acetylsalicylic acid (aspirin) is also taken by mouth as a tablet, 100 mg in this trial. It is a long‑standing, widely used drug for preventing repeat strokes and heart attacks. It reduces clot formation by blocking an enzyme that makes a substance that tells platelets to stick together. It is classified as a non‑steroidal anti‑inflammatory drug and an antiplatelet agent.

Investigated diseases

Acute ischemic stroke
A sudden loss of blood flow to part of the brain caused by a blockage in a cerebral artery. The reduced blood supply deprives brain tissue of oxygen and nutrients, leading to rapid loss of neurological function. Early symptoms may include weakness, speech difficulty, and visual changes. As the blockage persists, the affected brain area can become damaged, producing lasting deficits. Recovery depends on the size and location of the infarct and the body's natural repair processes.
Recurrent ischemic stroke
A new episode of brain tissue loss caused by another arterial blockage after a previous stroke. The new event can occur in the same or a different vascular territory and adds to the total brain injury. Each additional stroke may worsen neurological function and increase the area of permanent damage. The underlying vascular disease often continues to promote clot formation, leading to further events. Ongoing changes in the brain can result in cumulative impairment.