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Intra-arterial Selective Hypothermic Magnesium Sulfate Infusion in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE1/PHASE2

Intra-arterial Selective Hypothermic Magnesium Sulfate Infusion in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke

Selective Intra-arterial Hypothermic Magnesium Sulfate Infusion in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke: A Phase 1/2 Randomized Clinical Trial

NCT07163299•Capital Medical University

View on ClinicalTrials.gov

Summary

The primary objective of this study is to estimate the safety and effectiveness of selective intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy in patients with acute ischemic stroke

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age range of 18-80 years old (including critical value);
•2. No gender restrictions;
•3. The clinical diagnosis is acute ischemic stroke of the anterior circulation, and the site of acute occlusion of the responsible vessel is located in the intracranial segment of the internal carotid artery and the M1 or M2 segment of the middle cerebral artery;
•4. The symptoms and signs are consistent with acute anterior circulation ischemic stroke, NIHSS≥6;
•5. The time from onset to endovascular thrombectomy of acute ischemic stroke is within 24 hours;
•6. Indications for endovascular thrombectomy of acute ischemic stroke: ① ASPECTS score ≥ 6 points, within 6 hours of onset; ② 6-16 hours after onset, meeting DEFUSE-3 criteria (infarct core volume \< 70 mL, mismatch rate ≥ 1.8 and mismatch volume \> 15 mL) or DAWN criteria (NIHSS ≥ 10 and infarct core volume \< 31 mL); Or NIHSS ≥ 20 and infarct volume 31-51 mL); ③ Within 16-24 hours of onset, meet DAWN criteria (NIHSS ≥ 10 points and infarct core volume \< 31mL); Or NIHSS ≥ 20 points and infarct volume 31-51 mL)
•7. The mRS score before stroke is 0-1 points;
•8. Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria

•1. Clinical manifestations suggest the presence of intracranial cerebral parenchymal hemorrhage or subarachnoid hemorrhage (even if imaging results are normal);
•2. During a stroke, accompanied by epilepsy, an accurate NIHSS score cannot be obtained;
•3. Accompanied by coma or mental disorders, it may interfere with the assessment of neurological function;
•4. History of allergy to iodinated contrast agents or history of anaphylactic shock;
•5. Baseline blood glucose\<50mg/dL (2.78mmol) or\>400mg/dL (22.20mmol);
•\*Acceptable fingertip blood glucose results
•6. Baseline platelet count\<50 × 10\^9/L;
•7. Recently (i.e. within 30 days prior to inclusion in the study), there has been a history of significant gastrointestinal or other clinically significant bleeding; Active bleeding, abnormal coagulation factors, or bleeding tendency (taking anticoagulant drugs with INR ≥ 3 or PT ≥ 3 × ULN; if the researcher believes that the subject has no coagulation dysfunction, there is no need to wait for coagulation test results to determine whether to enroll);
•8. During a stroke, there may be fever or active infections that require systemic treatment (such as active pulmonary tuberculosis);
•9. History of chronic heart failure with NYHA criteria\>1; Uncontrolled hypertension (systolic blood pressure\>180mmHg or diastolic blood pressure\>105mmHg after standardized treatment), hypotension (systolic blood pressure ≤ 100mmHg after standardized treatment), unstable angina, myocardial infarction, or bypass or stent surgery within 6 months;
+14 more criteria

Locations (1)

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Key Dates

Start Date

September 15, 2025

Primary Completion Date

December 30, 2026

Completion Date

March 30, 2027

Last Updated

September 25, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Ischemic Stroke

Interventions

Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (350 ml).

PROCEDURE

Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (500 ml).

PROCEDURE

Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (650 ml).

PROCEDURE

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

NCT07253181

Acute Ischemic StrokeLarge Vessel Occlusion+1 more

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RECRUITINGPHASE2/PHASE3

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

NCT06990867

Acute Ischemic Stroke

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Intra-arterial Selective Hypothermic Magnesium Sulfate Infusion in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke

Inclusion Criteria

Exclusion Criteria

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

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