Effects of Minocycline on Patients With Ischemic Stroke Undergoing Intravenous Thrombectomy
ConditionIschemic Stroke, Acute
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with acute cerebral infarction of anterior circulation accompanied by large vessel occlusion;
Age 18-85 years old;
The time of onset ≤ 6 hours or ≤ 24 hours suitable for mechanical thrombectomy determined by multimodal imaging;
The time of onset 6-24 hours, DWI shows an infarct volume less than 1/3 of the MCA blood supply area; the time of onset ≤ 6 hours, the ASPECTS(Alberta Stroke Program Early CT Score) is ≥6;
Disqualifiers
There are contraindications for mechanical thrombectomy;
No revascularization therapy was performed during the operation or the TICI score after revascularization therapy was less than 2b;
There are other major central nervous system diseases, such as brain injury, brain tumor, multiple sclerosis, etc;
There is evidence that the patient has bacterial endocarditis, aortic dissection, arteritis or venous cerebral infarction;
Trial design
Design model
Parallel
Treatments tested in this trial
Minocycline
DrugMinocycline 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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Minocycline treatment groupExperimental treatment 1 intervention
Group B: Routine treatment groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in infarct volume from baseline to day 5
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
Day 5 after onsetSecondary outcomes
1
Functional outcome at 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 onset2
Favourable outcome at 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 onset3
Excellent outcome at 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
3 months after onset4
Improvement of neurological function compared with baseline
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
day 1, day 3, day 5, day 7, and 3 months after onsetOther outcomes
1
Safety outcomes: adverse events and serious adverse events
Safety outcomes were incidences of adverse events and serious adverse events that were related or not related to the study treatment.
Time frame
3 months after onsetSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xijing Hospital
Lead sponsor
Xi'an No.3 Hospital
Collaborator
Xi'an Gaoxin Hospital
Collaborator
First People's Hospital of Xianyang
Collaborator
Xi'an XD Group Hospital
Collaborator
Baoji High-tech Hospital
Collaborator
Weinan Central Hospital
Collaborator
Xi'An Daxing Hospital
Collaborator
Yan'an University Xianyang Hospital
Collaborator
The First Hospital of Yulin
Collaborator
Northwest University First Hospital
Collaborator
Jingyang County Hospital
Collaborator
Yulin No.2 Hospital
Collaborator
Yan'an People's Hospital
Collaborator
Yuncheng Central Hospital
Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborator
Xi'an No.9 Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Pucheng County Hospital
Collaborator
Source ClinicalTrials.gov