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Fibrinogenase for injection improves 90-day mRS scores in acute ischaemic stroke patientsFibrinogenase injection improves recovery for patients after a stroke

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Key Takeaway
Consider fibrinogenase for injection to improve 90-day functional outcomes in patients with acute ischaemic stroke.

This randomized controlled trial enrolled 235 patients aged 18-85 years with acute ischaemic stroke (AIS) and an NIHSS score of 4 to 25, treated within 72 hours of symptom onset. Patients who had not received reperfusion therapies were randomized to receive either fibrinogenase for injection or a placebo.

At 90 days, the fibrinogenase group showed significantly lower modified Rankin Scale (mRS) scores compared to the placebo group (OR 2.38; 95% CI 1.49 to 3.85; p<0.001). Additionally, the fibrinogenase group achieved significantly lower median NIHSS scores at 90 days compared to the placebo group (OR 1.95; 95% CI 1.23 to 3.10; p<0.001).

Safety data indicated that the incidence of haemorrhagic events and mortality during treatment was comparable between the fibrinogenase and placebo groups. However, evidence regarding specific treatment effects remains limited. Clinical benefits were most pronounced in patients treated within 48 hours of onset and those with mild to moderate stroke due to large artery atherosclerosis or small artery occlusion.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap in management for mild-to-moderate stroke patients. While a previous report noted that endovascular therapy showed no benefit over medical care alone for mild-to-moderate medium or distal vessel occlusion stroke patients, this trial suggests fibrinogenase may offer a different therapeutic pathway for similar patient profiles.

When a person suffers a stroke, every moment counts. Doctors are always looking for ways to help patients regain their independence and mobility after the initial emergency. A recent trial involving 235 patients in China looked at a treatment called fibrinogenase to see if it could improve outcomes for those who had not received other reperfusion therapies.

The study found that patients who received the fibrinogenase injection had significantly better functional outcomes after 90 days compared to those who received a placebo. These patients also showed lower scores on the NIHSS, which is a scale used to measure the severity of stroke symptoms. The results were particularly strong for people treated within 48 hours of their symptoms starting, as well as those with mild to moderate strokes caused by specific types of artery blockages.

Safety data showed that the risk of bleeding or death during treatment was similar between the two groups. While these results are promising, the researchers noted that the overall evidence for the treatment's effects is still limited. Because the data is still emerging, patients should talk to their doctors about how these findings might apply to specific cases.

What this means for you:
Fibrinogenase injection improved 90-day recovery for certain stroke patients compared to a placebo.

Common questions

Who is this treatment for?

This treatment was studied in patients aged 18 to 85 who had an acute ischemic stroke. Specifically, it was tested in patients with a severity score between 4 and 25 who were within 72 hours of their symptoms starting and had not received other reperfusion therapies.

Is the treatment safe?

The study found that the rate of bleeding events and deaths during treatment was comparable between the group that received fibrinogenase and the group that received a placebo. This means the safety profile was similar across both groups in this trial.

How much did it help patients?

Patients who received fibrinogenase had significantly better functional outcomes at 90 days than those who received a placebo. The benefit was especially clear for those treated within 48 hours of their symptoms and those with mild to moderate strokes from certain types of artery blockages.

Study Details

Study typeRct
Sample sizen = 235
EvidenceLevel 2
Follow-up1020.0 mo
PublishedAug 2026
View Original Abstract ↓
BACKGROUND: Fibrinogenase for injection is an effective antithrombotic agent for eligible patients with acute ischaemic stroke (AIS), but evidence regarding its treatment effects remains limited. This study aimed to evaluate the efficacy and safety of fibrinogenase for injection in patients with AIS who did not receive reperfusion therapies. METHODS: A multicentre, randomised, double-blind, placebo-controlled clinical trial was conducted at 12 hospitals in China. Inclusion criteria comprised patients aged 18-85 years with a diagnosis of AIS, an NIH Stroke Scale (NIHSS) score of 4 to 25 and within 72 hours of symptom onset. Eligible patients were randomly allocated in a 1:1 ratio to receive fibrinogenase for injection or placebo. The primary efficacy endpoint was the modified Rankin Scale (mRS) Score at 90 days after randomisation. RESULTS: Among 235 patients with AIS who were randomised, 233 were included in the intention-to-treat population (117 in the fibrinogenase for injection group and 116 in the placebo group). The mRS score at 90 days after randomisation was significantly lower in the fibrinogenase group (1 (0-2)) than in the placebo group (2 (1-3)), with a favourable shift in the distribution of mRS scores (OR 2.38, 95% CI 1.49 to 3.85; p<0.001). A significantly lower median NIHSS score at 90 days was observed in the fibrinogenase group (1 (0-2)) compared with the placebo group (2 (1-4)) (OR 1.95, 95% CI 1.23 to 3.10; p<0.001). The incidence of haemorrhagic events and mortality during treatment was comparable between the two groups. CONCLUSIONS: In patients with AIS, treatment with fibrinogenase for injection was associated with improved 90-day functional outcomes compared with placebo. This clinical benefit was particularly evident among those who were randomised within 48 hours of symptom onset and in those with mild to moderate stroke due to large artery atherosclerosis or small artery occlusion. TRIAL REGISTRATION NUMBER: ChiCTR2100042526; Chinese Clinical Trial Registry.
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