Lumbrokinase for Stroke: What Does the Research Say?
Quick Summary: This article discusses a research study protocol (a plan for a study) that will investigate if taking lumbrokinase along with aspirin helps people recover from a stroke better than taking aspirin alone. The study is still ongoing, so no results are available yet.
What The Research Found
This research is a plan for a study, not the actual results. The study is designed to see if combining lumbrokinase with aspirin is more effective than aspirin alone for treating acute ischemic stroke (a stroke caused by a blood clot). The researchers will measure how well people recover after a stroke using a scale that measures daily activities.
Study Details
- Who was studied: The study will include 220 people in China who have had their first ischemic stroke within the last 72 hours. They must be between 35 and 85 years old and have a specific score on a stroke severity scale.
- How long: Participants will be followed for 180 days (about 6 months).
- What they took: Half the participants will receive lumbrokinase plus aspirin for 90 days, and the other half will receive a placebo (a sugar pill) plus aspirin for the same period. After 90 days, everyone will take aspirin only for the remaining 90 days.
What This Means For You
- Important Note: This study is still in progress. We don't know if lumbrokinase is effective or safe for stroke treatment yet.
- Talk to your doctor: If you've had a stroke, follow your doctor's advice on the best treatments.
- Stay informed: Keep an eye out for the results of this study when they are published.
Study Limitations
- Location: The study is only being conducted in China, so the results might not apply to everyone.
- Specific Stroke Type: The study focuses on a specific type of stroke and excludes people with severe strokes or those who have received certain treatments.
- Short Follow-Up: The study only follows people for 6 months, which may not be long enough to see the full effects of the treatment.
- No Results Yet: Because this is a study protocol, there are no results to analyze.
Technical Analysis Details
Key Findings
This publication is a study protocol only; no efficacy or safety results are reported. The trial aims to determine whether lumbrokinase combined with aspirin improves functional outcomes compared to aspirin alone in acute ischemic stroke (AIS) patients. The primary hypothesis is that the combination therapy will yield superior outcomes on the modified Rankin Scale (mRS) at 180 days. No conclusions regarding efficacy or safety can be drawn from this protocol document.
Study Design
This is a multicenter, randomized, double-blind, placebo-controlled trial protocol (ChiCTR2000032952). It plans to enroll 220 participants aged 35–85 years with first-time AIS onset within 72 hours, NIHSS scores of 6–14, and no prior thrombolysis/intervention. Participants are randomized 1:1 to intervention (lumbrokinase + aspirin) or control (placebo + aspirin) for 90 days, followed by aspirin-only treatment and 90-day follow-up (total 180 days). Primary outcome is mRS score at 180 days; secondary outcomes include NIHSS, ADL Scale, coagulation markers, and hs-CRP.
Dosage & Administration
The protocol specifies lumbrokinase administration but does not disclose the exact dosage, formulation, or route in the provided summary. It states participants receive lumbrokinase (intervention) or placebo alongside aspirin (100 mg/day) for 90 days. Administration details (e.g., oral, frequency) are not quantified in the published protocol excerpt.
Results & Efficacy
No results are available as this is a protocol paper describing planned methodology. The study has not yet reported outcomes, effect sizes, p-values, or confidence intervals. Efficacy claims cannot be evaluated from this document.
Limitations
Key limitations inherent to the protocol design include: (1) Single-country focus (China), limiting generalizability; (2) Narrow eligibility criteria (NIHSS 6–14, no thrombolysis), excluding severe stroke cases; (3) Short 180-day follow-up, insufficient for long-term safety/efficacy assessment; (4) Reliance on surrogate markers (e.g., coagulation parameters) without established clinical correlation for lumbrokinase. Future research requires multi-ethnic trials and longer-term data.
Clinical Relevance
This trial addresses a critical evidence gap regarding lumbrokinase’s role in AIS management. If results (when published) demonstrate efficacy, it could support adjunctive lumbrokinase use with aspirin in early stroke recovery. However, current clinical practice should not incorporate lumbrokinase outside research settings due to the absence of published efficacy/safety data. Patients should rely on established therapies (e.g., aspirin, thrombolysis) per current guidelines until robust evidence emerges. Supplement users should await trial completion (estimated 2023–2024 per registration) before considering lumbrokinase for stroke prevention/recovery.
Original Study Reference
Efficacy and safety of lumbrokinase plus aspirin versus aspirin alone for acute ischemic stroke (LUCENT): study protocol for a multicenter randomized controlled trial.
Source: PubMed
Published: 2022
📄 Read Full Study (PMID: 35410433)
