⚠️ Teaching Case Note: This case has been de-identified and reconstructed for educational purposes. Clinical details reflect real surgical decision-making and outcomes. Patient identity is fully protected.
Rethinking Stroke Prevention: When Traditional Medicine Meets Randomized Evidence
Large-artery atherosclerotic ischemic stroke is the most common stroke subtype in China — and one of the most difficult to prevent from recurring. Standard antiplatelet therapy reduces risk, but recurrence rates remain substantial. The question facing clinicians at Huashan Hospital, Fudan University, and eleven other leading centers across China was whether a well-characterized traditional medicine extract could add meaningful protection on top of aspirin alone.
The answer, after 400 patients and 24 months of follow-up, was yes — with high-level evidence now incorporated into China's national cerebrovascular disease guidelines.
The Clinical Problem: High Recurrence, Limited Options
Large-artery atherosclerotic ischemic stroke carries a recurrence risk of 10–20% within the first year, with each recurrence compounding disability and mortality risk. Aspirin remains the cornerstone of secondary prevention, but its protective effect has a ceiling. Ginkgolide injection — derived from Ginkgo biloba — has been used in Chinese clinical practice for its antiplatelet and cerebral microcirculation-improving properties, but large-scale randomized evidence for stroke secondary prevention was lacking.
This multicenter trial was designed to fill that gap.
The Study: 400 Patients, 12 Centers, 24 Months
The trial enrolled 400 patients with confirmed large-artery atherosclerotic ischemic stroke across 12 tertiary hospitals in China. Patients were randomized to one of two arms:
- Trial group: Ginkgolide injection 200 mg/day (intravenous) plus aspirin enteric-coated 100 mg/day (oral)
- Control group: Aspirin enteric-coated 100 mg/day (oral) alone
Treatment continued for 12 months, with follow-up extended to 24 months. The primary endpoints were stroke recurrence rate and all-cause mortality. Secondary endpoints included neurological deficit scores (NIHSS), functional independence (Barthel Index), and a composite vascular endpoint encompassing non-fatal myocardial infarction and vascular death.
The Results: Significant Recurrence Reduction, Sustained at Two Years
Stroke recurrence was the headline finding. At 12 months, the recurrence rate in the ginkgolide group was 8.2%, compared to 14.5% in the aspirin-only group — a statistically significant reduction (P=0.032). At 24 months, the separation was maintained: 12.1% versus 18.7% (P=0.047). The absolute risk reduction of approximately 6 percentage points translates to a number needed to treat of roughly 16 patients to prevent one recurrent stroke over two years.
All-cause mortality showed a non-significant trend at 12 months (3.1% vs. 5.8%, P=0.187), but reached statistical significance at 24 months: 6.2% versus 11.3% (P=0.041). The delayed separation in mortality — emerging only at the two-year mark — is consistent with the cumulative protective effect of sustained recurrence prevention.
Neurological recovery favored the combination arm on both measures: NIHSS improvement was significantly greater (P=0.003), and Barthel Index gains were more pronounced (P=0.012), indicating better functional independence at follow-up.
Safety was reassuring. Serious adverse event rates were comparable between groups (12.3% vs. 14.1%, P=0.567). Intracranial hemorrhage rates were virtually identical (1.2% vs. 1.5%, P=0.765), confirming that the addition of ginkgolide injection did not increase bleeding risk — a critical consideration in any antiplatelet combination strategy.
What This Means for Patients
For patients who have survived a large-artery atherosclerotic ischemic stroke, the risk of a second event is the defining concern of recovery. These results suggest that ginkgolide injection added to standard aspirin therapy can meaningfully reduce that risk — cutting 12-month recurrence from roughly 1 in 7 patients to 1 in 12, without adding bleeding risk or serious adverse events.
The neurological recovery data add a further dimension: patients in the combination arm not only had fewer recurrences, but recovered more function. NIHSS and Barthel Index improvements suggest that the microcirculatory effects of ginkgolide may support neural recovery beyond simple recurrence prevention.
The findings were considered sufficiently robust to be incorporated into the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases (2025 Edition) — the national standard that governs stroke care across China's hospital system.
Expert Commentary — Dr. Qiang Dong
"Secondary prevention after large-artery atherosclerotic stroke has long been dominated by antiplatelet monotherapy and risk factor control. This trial adds a new dimension: a well-characterized traditional medicine extract, rigorously tested in a multicenter randomized design, demonstrating meaningful recurrence reduction over two years.
Three aspects of the data deserve emphasis. First, the recurrence benefit was consistent at both 12 and 24 months — this is not a short-term signal that fades. Second, the mortality separation emerged at 24 months, which is biologically coherent: preventing recurrent strokes prevents the cumulative disability and mortality that follows them. Third, the safety profile was clean — no increase in intracranial hemorrhage, no excess serious adverse events. For a combination antiplatelet strategy, that is a critical finding.
The incorporation of these results into the 2025 national guidelines reflects the quality of the evidence. For patients with large-artery atherosclerotic stroke who are candidates for this regimen, the data now support its use as part of a structured secondary prevention strategy."
About Dr. Qiang Dong
Dr. Qiang Dong is Director of the Department of Neurology at Huashan Hospital, Fudan University, with expertise in stroke, cerebrovascular disease, and cognitive disorders. He leads one of China's top neurology centers and is a pioneer in acute stroke intervention and neuroprotection research. Dr. Dong is widely regarded as one of Shanghai's foremost clinical neurologists, with a national leadership role in cerebrovascular disease guideline development and multicenter clinical research.
How CMCS Supported Patients in This Program
China Medical Concierge – Shanghai (CMCS) works with international patients and expatriates in Shanghai who have experienced stroke or are at elevated cerebrovascular risk. For patients seeking access to Dr. Dong's team at Huashan Hospital — including those interested in evidence-based secondary prevention programs — CMCS coordinates the full care pathway: specialist matching and appointment scheduling, pre-consultation imaging and laboratory logistics, on-site Mandarin-English interpretation for all neurology consultations, medication management support for complex antiplatelet regimens, and long-term follow-up coordination including neuroimaging surveillance and cognitive assessment.
For international patients navigating stroke recovery or cerebrovascular risk management in Shanghai, CMCS provides end-to-end support from first inquiry to long-term neurological follow-up.
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