NCT06621121 A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke
| NCT ID | NCT06621121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Huanhu Hospital |
| Condition | Stroke Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2024-10-26 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2024-10-26 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Stroke is the second leading cause of death worldwide, killing nearly 7 million people every year. Acute ischemic stroke is caused by focal cerebral hypoperfusion, usually due to embolism or atherosclerotic disease . Ischemic strokes account for 60-70% of all strokes worldwide and are severely debilitating, drawing considerable attention due to their high prevalence.The majority of studies comparing the efficacy and safety of teneplase and alteplase are predominantly randomized controlled trials with limited representation from real-world studies.The aim of this study is to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in clinical practice. This study aimed to establish a foundation for refining intravenous thrombolytic therapy tailored to various patient profiles and to guide clinicians in selecting the most suitable thrombolytic treatment options.
Eligibility Criteria
Inclusion Criteria: \- 1. Symptoms of neurological deficit caused by ischemic stroke; 2. The time from onset to treatment ≤4.5 hours; The time of onset of symptoms was defined as the time of last seen normal. 3\. Age ≥18 years old; 4. Signed informed consent by patients or their legally authorized representative. Exclusion Criteria: * 1\. Any absolute contraindication to thrombolysis in the \"Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023\" 2.Allergy to TNK or alteplase 3.Participation in another clinical trial within the previous 3 months. 4.Other conditions deemed inappropriate for participation in this study.
Contact & Investigator
Jialing Wu, MD,PhD
PRINCIPAL INVESTIGATOR
Tianjin Huanhu Hospital
Frequently Asked Questions
Who can join the NCT06621121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06621121 currently recruiting?
Yes, NCT06621121 is actively recruiting participants. Contact the research team at shoufengliu2010@163.com for enrollment information.
Where is the NCT06621121 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06621121 clinical trial?
NCT06621121 is sponsored by Tianjin Huanhu Hospital. The principal investigator is Jialing Wu, MD,PhD at Tianjin Huanhu Hospital. The trial plans to enroll 6,000 participants.
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