Xijing Hospital
Xi'an, China
Location status: Recruiting
Location contact
Wen Jiang
CONTACT
NCT Number: NCT05487417
Minocycline is the second generation of tetracycline. Because of its lipophilicity, it has high penetrance of blood-brain barrier. Animal model studies have shown that minocycline can reduce cerebral damage after ischemic stroke, and its mechanism involves multiple molecular pathways, such as antioxidant, anti-inflammatory, anti apoptotic pathways, and protection of blood-brain barrier. Clinical studies have also shown that minocycline can significantly improve 3-month National Institute of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) of patients with ischemic stroke, indicating that minocycline is a potential neuroprotective drug. Minocycline is believed to protect the blood-brain barrier, thereby reducing the ischemia-reperfusion injury caused by mechanical thrombectomy. However, whether minocycline can become a synergistic treatment method of mechanical thrombectomy, there is no clinical research in this area at present. Therefore, investigators carry out the study on the effect of minocycline in patients with acute anterior circulation ischemic stroke after mechanical thrombectomy, and plan to enroll 180 patients. To explore the safety and effectiveness of minocycline in patients with acute ischemic stroke after thrombectomy.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 4
Xi'an, China
Location status: Recruiting
Wen Jiang
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Minocycline is a tetracycline antibiotic. Previous studies have confirmed that its application in stroke patients has good efficacy and safety, suggesting that it could become a synergistic treatment of mechanical thrombectomy.
Time frame: Day 5 after onset
Baseline infarct volume is measured by diffusion-weighted imaging (DWI), day 5 infarct volume is measured by fluid attenuated inversion recovery (FLAIR), Images are processed by imSTROKE software.
Time frame: 3 months after onset
Defined by the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death), analyzed for superiority and then for noninferiority.
Time frame: 3 months after onset
Defined as proportion of patients with modified Rankin Scale (mRS) 0-2, which ranges from 0 (no symptoms) to 6 (death), An mRS score of <3 indicated a favourable outcome, whereas a score of ≥3 indicated a poor outcome.
Time frame: 3 months after onset
Defined as proportion of patients with modified Rankin Scale (mRS) 0-1, which ranges from 0 (no symptoms) to 6 (death), An mRS score of <2 indicated a excellent outcome, whereas a score of ≥2 indicated a poor outcome.
Time frame: day 1, day 3, day 5, day 7, and 3 months after onset
Defined by the National Institute of Health Stroke Scale (NIHSS), which ranges from 0 (no neurological injury) to 42 (severe neurological injury). The assessment time points were baseline, day 1, day 3, day 5, day 7, and 3 months after onset.
Time frame: 3 months after onset
Defined by Barthel index (BI), which ranges from 0 (completely lose the ability to live independently) to 100 (complete ability to live independently). The assessment time points were 3 months after onset
Time frame: Day 1 after onset
Intracranial hemorrhage is measured by CT scan. Images are processed by RAPID ICH software.
Time frame: 3 months after onset
The investigators record all-cause mortality
Time frame: Day 5 after onset
Day 5 infarct volume is measured by fluid attenuated inversion recovery (FLAIR). Images are processed by imSTROKE software.
Time frame: 3 months after onset
How long the patients stay in hospital, and how long the patients stay in ICU
Time frame: 3 months after onset
Safety outcomes were incidences of adverse events and serious adverse events that were related or not related to the study treatment.
Contact information is provided by the study sponsor or research team.
Fang Yang, Ph.D
CONTACT
Wen Jiang, Ph.D
CONTACT
Xijing Hospital
Other
Effects of Minocycline on Patients With Acute Anterior Circulation Ischemic Stroke Undergoing Intravenous Thrombectomy
Acronym: MIST-A
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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