Ischemic Stroke
Conditions
Keywords
thrombolysis, minor stroke, early antiplatelet
Brief summary
The current guideline recommends to give antithrombotic treatment 24 hours after intravenous thrombolysis in acute ischemic stroke. However, early neurological deterioration will occur in some patients due to no antithrombotic treatment, which is closely associated with poor outcome. The current trial aims to investigate the effectiveness and safety of early antithrombotic treatment after intravenous thrombolysis in minor stroke.
Interventions
DRUGAspirin 100mg; Clopidogrel 300mg
Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old; * Acute ischemic stroke patients who received intravenous thrombolysis within 4.5 hours of onset; * NIHSS ≤ 5 within 6 hours after the end of intravenous thrombolysis, and no bleeding transformation was found in head CT examination; * Premorbid mRS ≤ 1; * Signed informed consent.
Exclusion criteria
* Premorbid mRS≥2; * Uncontrolled severe hypertension (systolic pressure \>180 mmHg or diastolic pressure \>110 mmHg after drug treatment); * Antithrombotic treatment within 24 hours before randomization; * Significant dysphagia and inability to take the experimental drug orally; * Allergy or contraindication to study drugs; * Comorbidity with any serious diseases and life expectancy is less than half a year; * Participating in other clinical trials within three months; * Patients not suitable for this clinical study considered by researcher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of excellent prognosis | Day 90 | excellent prognosis is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of modified Rankin Score (mRS) | Day 90 | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome. |
| Changes in National Institute of Health stroke scale (NIHSS) | 24 hours, 48 hours, and 10 days | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome. |
| Occurrence of early neurologyical deterioration (END) | 24 hours | END is defined as more than 2 point increase, but not result of cerebral hemorrhage, compared with baseline at 24 hours |
| The proportion of favorable prognosis | Day 90 | Favorable prognosis is defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome. |
| The incidence of any intracerebral hemorrhage | 36 hours | the evidence of bleeding on the head CT or MRI scan |
| The incidence of stroke recurrence and other vascular events | Day 90 | — |
| The death due to any cause | Day 90 | — |
| The incidence of symptomatic intracerebral hemorrhage | 36 hours | any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase) |
Countries
China
Outcome results
None listed