NCT06545734 Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion
| NCT ID | NCT06545734 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Huanhu Hospital |
| Condition | Stroke, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-02-05 |
| Primary Completion | 2024-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-02-05 with a primary completion date of 2024-09.
⚠ 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
The goal of this clinical trial is to determine if direct ischemic post-conditioning (IPostC) can alleviate ischemic-reperfusion injury (I/R) in patients who have undergone endovascular thrombectomy (EVT). Additionally, the study aims to explore the underlying mechanisms of direct IPostC. The primary questions this trial seeks to answer are: 1. Is direct IPostC effective for acute stroke patients with large vessel occlusion? 2. What are the underlying mechanisms of direct IPostC? Participants will be randomly assigned to one of two groups: an EVT alone group or an EVT plus direct IPostC group. Direct IPostC will be administered immediately after EVT through four cycles of mechanical interruptions of reperfusion. We will evaluate outcomes based on final infarct volume, infarct volume growth, clinical parameters, and I/R-related imaging and laboratory biomarkers. Additionally, an exploratory multi-omics analysis will be conducted to uncover the detailed mechanisms of direct IPostC.
Eligibility Criteria
Inclusion Criteria: 1. Ischemic stroke confirmed by CT or MRI. 2. Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal 3. carotid artery (ICA) and middle cerebral artery (MCA M1/M2). 4\. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy. 5\. The patient or legally authorized representative has signed an informed consent form. Exclusion Criteria: 1. Inability to perform an MRI or CT scan for any reason. 2. Presence of any condition that would interfere with neurological assessment or any psychiatric disorders. 3. Stroke onset accompanied by seizures, resulting in the inability to obtain an accurate NIHSS baseline. 4. Pregnancy. 5. Presence of other serious, advanced, or terminal illnesses.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06545734 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.
What phase is the NCT06545734 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06545734 currently recruiting?
Yes, NCT06545734 is actively recruiting participants. Contact the research team at drweiming@163.com for enrollment information.
Where is the NCT06545734 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06545734 clinical trial?
NCT06545734 is sponsored by Tianjin Huanhu Hospital. The trial plans to enroll 60 participants.
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