Randomized study of Mechanical Thrombectomy vs. best medical treatment for stroke at 24 to 72 hours of Last Known Well

JRCT ID: jRCT1032230344

Registered date:12/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 12/09/2023
• Target sample size: 260
• Study type: Interventional

Intervention(s)

To compare the efficacy and safety of endovascular treatment and medical treatment.
Endovascular treatment group: General medical treatment is performed in addition to endovascular treatment.
Medical treatment group: general medical treatment by drip infusion and medication.

Outcome(s)

• Primary Outcome: Rate of independent living (mRS) 0-2 (ITT) 90 days (+- 10 days) after onset (or final confirmation of good health) (superiority)

Secondary Outcome

-Proportion of independent living (mRS) 0-2 (PPS) 90 days (+- 10 days) after onset (or final confirmation of good health) (superiority)
-Improvement in mRS 90 days (+- 10 days) after onset (or final confirmation of good health) (ordered logistic regression analysis) (ITT, PPS, AT) (superiority)
-Rate of independent living (mRS) 0-1 (ITT) 90 days (+-10 days) after onset (or final confirmation of good health) (superiority)
-Rate of independent living (mRS) 0-3 (ITT) 90 days (+-10 days) after onset (or final confirmation of good health) (superiority)
-Proportion of recanalization (Modified Mori Grade 3) 48+-36 hours after randomization

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 20 years of age or older
2. Patients with acute stroke 24-72 hours after the last healthy check
3. Subjects with a pre-randomization NIHSS score of 6 or higher
4. Subjects with pre-onset modified Rankin Scale score of 2 or less
5. Subjects who can confirm ICA (cervical and intracranial) and M1 obstruction by MRA or CTA
6. Subjects who can undergo endovascular treatment promptly after randomization
7. Pre-allotment detailed DWI-ASPECTS (10-point scale) of 6 or more (ASPECTS are evaluated by detailed DWI-ASPECTS, which deducts points for M1-M6 with a high signal of 1/2 or more) or CT-ASPECTS of 6 or more
8. Subjects who explained this research using an explanation document and obtained written consent

Exclude criteria

1. Patients who are unsuitable for endovascular treatment, such as having a history of hypersensitivity to contrast media
2. Patients with serious renal disease (not limited to those on dialysis)
3. Patients who are Lactating, or who are or may be pregnant
4. Patients who are expected to have a life expectancy of 90 days or less
5. Patients with a history of hypersensitivity to contrast media and for whom endovascular treatment is inappropriate

Related Information

• Primary Sponsor: Kimura Kazumi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Japanese Society for Neuroendovascular Therapy