Results from recent several trials provided data showing limits to the effectiveness of thrombectomy for ischemic stroke due to medium vessel occlusions.The benefit-risk profile of thrombolysis for these patients has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of tenecteplase (0.25mg/kg, maximum dose 25mg) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 4.5 to 24 hours from symptom onset.
Adult acute ischemic stroke patients due to primary medium vessel occlusions (distal M2/M3 segments of the middle cerebral artery, A1/A2/A3 segments of the anterior cerebral artery, and P1/P2/P3 segments of the posterior cerebral artery confirmed by CTA/MRA, and responsible for the signs and symptoms of acute ischemic stroke) with baseline National Institutes of Health Stroke Scale (NIHSS) ≥6 or NIHSS 3-5 with disabling symptoms will be enrolled in this trial. We use perfusion imaging to select subjects and the enrolled patients have target mismatch profile on CTP or MRI+PWI (ischemic core volume \<70mL, mismatch ratio\>1.2, mismatch volume \>10mL). If neither MRI or CT perfusion is available at the site, an ASPECTS/PC-ASPECTS of 8 or more on NCCT /MRI-DWI will be used.We will randomly assign eligible patients to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or standard medical treatment 4.5 to 24 hours after the time that the patient was last known to be well (including after stroke on awakening and unwitnessed stroke). The primary outcome is the proportion of patients with an mRS score ≤ 1 at 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
596
Each vial of tenecteplase is reconstituted with 3 ml sterile water for injection and adjusted to a concentration of 5.33 mg/ml. Calculate the total amount of drug according to the subject's actual body weight and measure the required drug volume. The maximum dose should not exceed 25mg. Tenecteplase should be given as a single, intravenous bolus (within 5-10 seconds).
Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone after randomization at the discretion of site researchers according to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.
Beijing tiantan hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGJiuquan city people's hospital
Jiuquan, Gansu, China
RECRUITINGXingtang People's Hospital
Shijiazhuang, Hebei, China
RECRUITINGJiyuan Traditional Chinese Medicine Hospital
Jiyuan, Henan, China
RECRUITINGThe first people hospital of lingbao
Lingbao, Henan, China
RECRUITINGHai'an People's Hospital
Nantong, Jiangsu, China
RECRUITINGThe First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGmRS score ≤ 1 at 90 days
The proportion of patients with an mRS score ≤ 1 at 90 days
Time frame: 90 days
mRS score
Ordinal distribution of mRS at 90 days (shift analysis)
Time frame: 90 days
mRS score ≤ 2
The proportion of patients with an mRS score of 0-2 at 90 days
Time frame: 90 days
Early neurological improvement
The rate of early neurological improvement at 24h after randomization (defined as a NIHSS score ≤1 or ≥4 points compared with the baseline)
Time frame: 24 hours
mRS 5-6
mRS 5-6 at 90 days
Time frame: 90 days
EuroQol 5-Dimension (EQ-5D) index
EuroQol 5-Dimension (EQ-5D) index at 90 days and 1 year
Time frame: 90 days and 1 year
mRS score at 1 year
mRS score at 1 year
Time frame: 1 year
Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage within 36 hours (defined by the SITS-MOST criteria)
Time frame: 36 hours
All-cause mortality
All-cause mortality at 90 days and 1 year
Time frame: 90 days and 1 year
Systemic bleeding
Systemic bleeding at 90 days (defined by the GUSTO criteria: moderate and severe bleeding)
Time frame: 90 days
Adverse events (AEs)/ serious adverse events (SAEs)
Adverse events (AEs)/ serious adverse events (SAEs) within 90 days
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.