Evaluating Sarecycline for Acute Ischemic Stroke Treatment

Efficacy and Safety of Sarecycline in Patients With Acute Ischemic Stroke After Reperfusion Therapy: A Phase II, Randomized, Multicenter, Double-blind, Single Dose, Placebo-controlled Parallel Trial

This study is testing if a new medication called Sarecycline can help improve recovery for people who have had an acute ischemic stroke and received treatment within 24 hours.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05836753 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of Sarecycline compared to a placebo in patients who have experienced acute ischemic stroke due to large vessel occlusion and have undergone reperfusion therapy within 24 hours of symptom onset. It is a prospective, randomized, multicenter, double-blind, placebo-controlled trial that will evaluate the impact of Sarecycline on neurological deficits and venous thrombotic inflammation indicators over a 7-day treatment period. Participants will be monitored through a screening/baseline period, treatment period, and follow-up period to gather comprehensive data on the drug's effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have experienced their first acute large vessel occlusion stroke and are scheduled for reperfusion therapy within 24 hours.

Not a fit: Patients with a history of pseudomembranous colitis, known allergies to tetracycline antibiotics, or those who have had prior strokes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: While this approach is novel in the context of Sarecycline for acute ischemic stroke, similar studies have explored the use of other treatments for improving outcomes post-reperfusion therapy.

Eligibility criteria

Inclusion criteria:

1. 18≤Age≤80 years old;
2. Acute large vessel occlusion (LVO) confirmed by imaging (CT+CTA+CTP/MRI+MRA), including the responsible vessel was located in the intracranial internal carotid artery, the T-shaped branch, the M1/M2 segment of the middle cerebral artery, or the A1/A2 segment of the anterior cerebral artery;
3. ASPECTS≥6;
4. 7≤NIHSS≤25,and Ia≤1;
5. Scheduled for reperfusion therapy within 24 hours of onset (including intravenous rt-PA or TNK-tPA thrombolysis (within 4.5 hours), mechanical thrombectomy, and bridging therapy);
6. First stroke or complete self-care before the onset of current stroke (mRS 0-1);
7. Patients or his/her legal representatives are able to understand and sign the informed consent.

Exclusion criteria:

1. History of pseudomembranous colitis or antibiotic-related colitis.
2. Allergic to tetracycline antibiotics or any component of the investigational drug.
3. Known to be resistant to other tetracyclines.
4. History of intracranial hemorrhagic diseases within the previous 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc.
5. Intracranial tumors, vascular malformations, and other intracranial space-occupying lesions.
6. Bilateral or posterior circulation LVO.
7. Rare or unknown etiology of LVO, such as dissection and vasculitis.
8. Severe hepatic or renal insufficiency and various reasons for receiving dialysis before randomization (Severe hepatic insufficiency was defined as ALT \>3 times the upper limit of normal value or AST \>3 times the upper limit of normal value; Severe renal insufficiency refers to serum creatinine \>3.0 mg/dl (265.2 μmol/L) or glomerular filtration rate\<30 ml/min).
9. Bleeding tendency (including but not limited to): platelet count \<100×109/L; Oral warfarin, INR \> 2; Received heparin within previous 48 hours, APTT≥35s; Hereditary hemorrhagic diseases, such as hemophilia.
10. Received any of the following treatments within the previous 3 months: systemic retinoic acid, androgen/antiandrogen therapy (e.g., anabolic steroids, andiolactone).
11. Refractory hypertension that is difficult to control with medication (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg).
12. History of intracranial or spinal surgery within the previous 3 months; History of therapeutical surgery or major physical trauma within the previous 1 month.
13. Have other investigator-evaluated contraindications of reperfusion therapy.
14. Women of childbearing age who do not use effective contraception and have no negative pregnancy test records; Women during lactation and pregnancy.
15. Life expectancy of fewer than 6 months due to advanced stage of any comorbidity.
16. Participated in other interventional clinical trials within the previous 3 months.
17. Other conditions that are not suitable for participating in this clinical trial, such as inability to understand and/or follow the research procedures due to mental, cognitive, emotional, or physical disorders, etc.

Where this trial is running

Beijing

• Beijing Tiantan Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Yilong Wang, PhD，MD — Beijing Tiantan Hospital, Capital Medical University, Beijing, , China
• Study coordinator: Yilong Wang, PhD，MD

Conditions Ischemic Stroke, Acute; Ischemic Stroke, Sarecycline