NCT07338175 Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage
| NCT ID | NCT07338175 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,192 participants |
| Start Date | 2026-04-02 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,192 participants in total. It began in 2026-04-02 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. It aims to evaluate the efficacy and safety of oral minocycline in patients with acute spontaneous intracerebral hemorrhage within 48 hours of onset.
Eligibility Criteria
Inclusion Criteria: 1. CT-confirmed spontaneous supratentorial intracerebral hemorrhage; 2. Aged 18 to 80 years; 3. Within 48 hours of symptom onset; 4. Hematoma volume 15-40 ml; 5. NIHSS score 8-24, with item 1a ≤ 2; 6. Signed informed consent by the patient or legal representative. Exclusion Criteria: 1. Secondary intracerebral hemorrhage (traumatic, tumor-related, vascular malformation, aneurysm, coagulation disorder, etc.); 2. Intraventricular hemorrhage filling one entire lateral ventricle, third ventricle, or fourth ventricle, or more than half of two lateral ventricles; 3. Significant subarachnoid hemorrhage (Fisher grade ≥ 3) or subdural hemorrhage; 4. Patients with uncontrollable hypertension ( systolic blood pressure persistently ≥ 180 mmHg despite intensive antihypertensive treatment); 5. Progressive neurological or other severe systemic diseases; 6. Planned surgical intervention for the intracerebral hemorrhage; 7. Pre-stroke disability (modified Rankin Scale score \> 1); 8. Severe cardiac insufficiency (NYHA Class III-IV), severe liver disease (ALT or AST \> 3 times the normal upper limit value), severe renal insufficiency (serum creatinine \> 2 times the normal upper limit value, or glomerular filtration rate \< 45 ml/min), or malignancy with life expectancy \< 1 year; 9. Moderate to severe anemia (hemoglobin \< 90 g/L), thrombocytopenia (platelet count \< 100×10\^9/L), leukopenia (white blood cell count \< 2×10\^9/L), or coagulopathy (INR \> 1.5); 10. Allergy or intolerance to minocycline or other tetracycline antibiotics; 11. History of pseudomembranous enteritis or antibiotic-associated enteritis; 12. Use of tetracycline antibiotics within the past week; 13. Intracranial or spinal surgery within the past 3 months; 14. Any major surgery or severe physical trauma within the past month; 15. Females who are pregnant, within 30 days postpartum, or in the lactation period. 16. Participated in other interventional clinical trials within the past 3 months; 17. Inability to obtain signed informed consent from the patient or representative; 18. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07338175 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07338175 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,192 participants.
Is NCT07338175 currently recruiting?
Yes, NCT07338175 is actively recruiting participants. Contact the research team at kangkaijiang678@126.com for enrollment information.
Where is the NCT07338175 trial being conducted?
This trial is being conducted at Beijing, China, Chongqing, China, Guangzhou, China, Baoding, China and 11 additional locations.
Who is sponsoring the NCT07338175 clinical trial?
NCT07338175 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 1,192 participants.