Tests clot-busting drug for mild, non-disabling stroke

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have had a mild stroke from a blocked blood vessel in the brain within the last 4.5 hours, with weakness-free symptoms, to see if clot-dissolving drugs help.

Age

Over 18 years

Sex

All sexes

Disease stage

Acute ischemic stroke within 4.5 hours of onset (or of waking up with stroke symptoms, counted from the midpoint of sleep). NIHSS score of 5 or less, arm and leg score of 0, and at least one of these items scoring 2 or more: gaze, vision, facial palsy, limb ataxia, sensation, language, dysarthria, extinction and inattention.

Earlier treatment

People who plan to receive endovascular treatment cannot join. Recent heparin, low-molecular-weight heparin, warfarin, thrombin inhibitors or factor Xa inhibitors can rule people out.

Main reasons for not taking part

• Plan to receive endovascular treatment
• Disability before the stroke (mRS score above 2)
• Bleeding inside the skull now or in the past
• Blood pressure of 180 mmHg or more (top number) or 100 mmHg or more (bottom number)
• Large area of brain infarction on CT or MRI

The registry criteria, word for word

What the trial wants to find out

Minor stroke is considered an acute ischemic stroke (AIS) that has a National Institute of Health Stroke Scale (NIHSS) score ≤ 5 points. About 1/3 patients with mild stroke have poor prognosis, whether patients with this type undergo thrombolysis has been a controversial issue. A pooled analysis published in the Lancet in 2014 included 9 high-quality RCT studies of intravenous thrombolysis such as NINDS and IST3, and a total of 666 (10%) patients with mild stroke were included in the analysis. For mild stroke, the proportion of good prognosis in the control group and the alteplase group was 58.9% and 68.7% (OR 1.48, 95%Cl 1.07-2.06), respectively. Therefore, guidelines recommended alteplase thrombolytic therapy for patients with mild stroke. However, PRISMS, a randomized controlled trial of intravenous thrombolytic therapy for mild stroke published in 2018, found that alteplase intravenous thrombolytic therapy did not improve clinical outcomes compared with aspirin in patients with mild non-disabled stroke (90-day mRS 0-1 ratio 78.2% vs 81.5%), and the incidence of symptomatic intracranial hemorrhage was higher. However, a major limitation of the PRISMS study was that more than 85% of patients had numbness and dysarticulation, so this conclusion cannot be extrapolated to patients with other mild stroke symptoms. Moreover, due to the early termination of the sponsorship of this trial, the number of enrolled cases did not reach the pre-designed number, resulting in a serious decline in the authenticity of the study results. Symptoms and outcomes of minor stroke are important criteria for assessment. However, there is currently no uniform standard for the assessment of disability.

The 2 groups in the trial

• Intravenous thrombolysis (alteplase and other guideline-recommended thrombolytic agents)Treatment being tested

  Patients will receive standard dose intravenous alteplase (0.9 mg/kg, the first 10% administered as an initial bolus and the remainder over a 1-hour period, with a maximum dose of 90 mg)，intravenous Tenecteplase(0.25mg/kg，administered as a single intravenous bolus injection over 5 - 10 seconds，with a maximum dose of 25 mg), intravenous reteplase (a bolus of 18 mg followed by a second bolus of 18 mg after 30 minutes) and intravenous prourokinase (rhPro-UK) (15 mg bolus followed by a 20 mg infusion over 30 minutes).

• Standard therapyNo study treatment, for comparison