Protocol for argatroban plus clopidogrel versus aspirin plus clopidogrel in acute minor ischemic strokeStudy will compare two blood thinner combinations for minor strokes

medRxiv Published April 4, 2026 Study authors: Zhang, H.; Ma, X.; Xiao, Y.; Liao, G.; Kong, N.; Qin, T.; Huang, M.; Yin, Z.; Chen, W.; Wu, J.; Xian… DOI ↗ Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain

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Key Takeaway

Note: This is only a study protocol; no efficacy or safety results are available.

This is a published study protocol for a planned randomized controlled trial. The trial will enroll 464 patients with acute minor ischemic stroke, defined as NIHSS ≤5, within 72 hours of the last known well time. The setting is multicenter across four centers in China. The study design compares an intervention of intravenous argatroban combined with clopidogrel against a comparator of aspirin plus clopidogrel.

The primary outcome is the proportion of patients achieving an excellent functional outcome, defined as a modified Rankin Scale score of 0-1, at the 90-day follow-up. Secondary outcomes are not detailed in the protocol. No main results, efficacy data, or safety outcomes are reported, as this document only describes the planned methodology. Information on adverse events, serious adverse events, discontinuations, and tolerability is not available.

Key limitations stem from this being a protocol publication. The actual trial execution, adherence, data quality, and final results are unknown. The funding source and potential conflicts of interest are not reported. The practice relevance of this comparison cannot be determined until the trial is completed and its results are published, peer-reviewed, and replicated. This protocol outlines a hypothesis to be tested, not an established clinical finding.

Researchers have created a plan for a future study to see if one combination of blood-thinning drugs works better than another for people who have had a minor stroke. The study will focus on patients who had a minor ischemic stroke, which is a stroke caused by a blocked blood vessel in the brain. Their stroke symptoms were mild, with a score of 5 or less on a standard scale, and they will be enrolled within 72 hours of their symptoms starting.

The study will take place at four medical centers in China and will include 464 patients. One group will receive the drug argatroban along with clopidogrel. The other group will receive the more common combination of aspirin plus clopidogrel. The main goal is to see which group has more people with an excellent recovery, meaning minimal or no disability, 90 days after their stroke.

It is very important to understand that this document only describes the plan for the study. The research has not been completed, so there are no results to report. We do not know if one treatment is better, safer, or has fewer side effects. The study is designed to find that out. Readers should know this is a look at a research plan, not a report of findings. The real value will come when the study is finished and the results are published.

What this means for you:

This is a plan for a future study. No results on which stroke treatment is better are available yet.

Study Details

Study typeRct

EvidenceLevel 2

PublishedMar 2026

View Original Abstract ↓

BackgroundPrevious studies have shown the benefit of dual antiplatelet therapy (DAPT) for acute minor ischemic stroke. Argatroban, is a thrombin inhibitor and is primarily used in patients with acute ischemic stroke experiencing early neurological deterioration. There is no study about the benefit of antiplatelet plus anticoagulant in this population. We aim to study the difference between the combination of argatroban and clopidogrel and DAPT in the outcomes of patients with acute minor ischemic stroke (AMIS, NIHSS [≤]5) presenting within 72 hours after onset. MethodsArgatroban combined with clopidogrel versus aspirin combined with clopidogrel in Stroke (ACAP study) is an investigator-initiated, multicenter, prospective, randomized, open-label trial with blinded endpoint evaluation conducted at four centers in China. This trial will randomize 464 eligible patients with minor ischemic stroke of NIHSS [≤] 5 (232 in each arm) within 72 hours of the last known well to receive intravenous argatroban with clopidogrel (treatment group) or aspirin plus clopidogrel (control group). The primary outcome is the proportion of patients achieving excellent outcome, defined as a score of 0-1 on the modified Rankin scale, at 90 days. ConclusionsThe ACAP trial will provide important data on the role of intravenous argatroban in patients with acute minor ischemic stroke presenting within 72 hours of last known well. RegistrationURL: https://www.chictr.org.cn; Unique identifier: ChiCTR2400080890; Date of registration: Feb 17, 2024.

Protocol for argatroban plus clopidogrel versus aspirin plus clopidogrel in acute minor ischemic strokeStudy will compare two blood thinner combinations for minor strokes

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Protocol for argatroban plus clopidogrel versus aspirin plus clopidogrel in acute minor ischemic strokeStudy will compare two blood thinner combinations for minor strokes

More on Minor Ischemic Stroke

Study Details

Intravenous tenecteplase improves functional outcomes but increases hemorrhage risk in non-large vessel occlusion acute ischemic stroke

Tenecteplase improves stroke recovery but increases bleeding risk in late treatment window

Clinical research that matters. Delivered to your inbox.

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