Actively Recruiting
Efficacy and Safety of QD202 in Participants With Acute Ischemic Stroke Undergoing Thrombolysis Excluding Endovascular Thrombectomy
Led by Shanghai QuietD Biotechnology Co., Ltd. · Updated on 2026-05-12
120
Participants Needed
14
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blinded, placebo-controlled study investigating the safety and efficacy of QD202 injection in patients with acute ischemic stroke undergoing thrombolysis excluding endovascular thrombectomy. Up to 120 male and female patients with acute ischemic stroke undergoing thrombolysis excluding endovascular thrombectomy will be dosed with QD202 injection or placebo as a 60 minute intravenous infusion after completion of the thrombolysis procedure on Day 1-5 of the study period. Subjects will undergo interim procedures at Day 7 or the day of discharge, Day 30, and end-of-study procedures on Day 90.
CONDITIONS
Official Title
Efficacy and Safety of QD202 in Participants With Acute Ischemic Stroke Undergoing Thrombolysis Excluding Endovascular Thrombectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 85 years, any gender
- Diagnosed with acute ischemic stroke based on Chinese guidelines
- Stroke onset within 24 hours before enrollment
- Pre-stroke modified Rankin Scale score of 1 or less
- NIHSS score between 6 and 20 before thrombolysis, with motor arm and leg scores totaling at least 2
- Planned for or have received thrombolytic therapy
- Female participants of childbearing potential with negative pregnancy test and no sexual activity within 14 days prior to screening
- Agreement to avoid pregnancy or sperm donation during the study and use effective contraception
- Signed informed consent form by participant or legal guardian
You will not qualify if you...
- Allergy to QD202 or placebo components
- Intracranial hemorrhage detected by CT, except minor microbleeds at investigator's discretion
- Transient ischemic attack (TIA)
- Poorly controlled blood pressure despite treatment (systolic ≥220 mmHg or ≤90 mmHg, diastolic ≥120 mmHg or ≤40 mmHg)
- Severe high or low blood sugar (glucose ≥400 mg/dL or ≤50 mg/dL)
- Abnormal heart rate (<50 or >120 bpm) or serious heart conditions within 6 months
- Severe impaired consciousness before thrombolysis (NIHSS consciousness score ≥2)
- History of severe psychiatric disorders, dementia, or recent depression/anxiety deemed unsuitable
- Not suitable for thrombolytic therapy or undergoing/planned for endovascular therapy
- Use of certain neuroprotective drugs after stroke onset (except mannitol)
- Current cancer treatment
- Severe systemic disease with life expectancy under 90 days
- Severe active liver or kidney disease
- Bleeding tendency or recent major bleeding
- Major surgery within 4 weeks affecting neurological status
- Alcohol or drug dependence
- Participation in another clinical trial within 3 months
- Contraindications for CT or MRI
- Allergy to contrast agents
- Chronic moderate to severe respiratory disease
- Pregnant or breastfeeding
- Any other condition making participation unsuitable per investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 14 locations
1
Meizhou People's Hospital
Meizhou, Guangdong, China
Actively Recruiting
2
Luoyang Central Hospital
Luoyang, Henan, China
Actively Recruiting
3
Nanshi Hospital of Nanyang
Nanyang, Henan, China
Actively Recruiting
4
Jilin Province People's Hospital
Changchun, Jilin, China
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5
Meihe Hospital the First Hospital of Jilin University
Meihekou, Jilin, China
Actively Recruiting
6
Benxi Central Hospital
Benxi, Liaoning, China
Actively Recruiting
7
General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
Fuxin, Liaoning, China
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8
Central Hospital Affiliated to Shenyang Medical College
Shengyang, Liaoning, China
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9
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Actively Recruiting
10
Linyi People's Hospital
Linyi, Shandong, China
Actively Recruiting
11
Weifang People's Hospital
Weifang, Shandong, China
Actively Recruiting
12
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
13
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
14
Linfen Central Hospital
Linfen, Shanxi, China
Actively Recruiting
Research Team
Y
Yichuan Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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