Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage
ConditionIntracerebral Hemorrhage
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
CT-confirmed spontaneous supratentorial intracerebral hemorrhage;
Aged 18 to 80 years;
Within 48 hours of symptom onset;
Hematoma volume 15-40 ml;
Disqualifiers
Secondary intracerebral hemorrhage (traumatic, tumor-related, vascular malformation, aneurysm, coagulation disorder, etc.);
Intraventricular hemorrhage filling one entire lateral ventricle, third ventricle, or fourth ventricle, or more than half of two lateral ventricles;
Significant subarachnoid hemorrhage (Fisher grade ≥ 3) or subdural hemorrhage;
Patients with uncontrollable hypertension ( systolic blood pressure persistently ≥ 180 mmHg despite intensive antihypertensive treatment);
Trial design
Design model
Parallel
Treatments tested in this trial
Minocycline hydrochloride capsules
Drug50 mg per capsule, containing 50mg of Minocycline Hydrochloride
Placebo capsules of Minocycline hydrochloride capsules
Drug50 mg per capsule, containing 0 mg of Minocycline Hydrochloride
Treatment groups
1,192 Participants
are divided into 2 treatment groupsGroup A: Active Comparator: Minocycline treatment groupExperimental treatment 1 intervention
Group B: Placebo Comparator: Minocycline placebo-control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
mRS score 0-3
Modified Rankin Scale score
Time frame
At 90±7 days after randomizationSecondary outcomes
1
mRS score
Modified Rankin Scale score
Time frame
At 90±7 days and 180±7 days after randomization2
Changes in NIHSS score compared with baseline score
NIHSS score
Time frame
At 72±12 hours and 7±1 days after randomization3
Changes in Glasgow Coma Scale score compared with baseline score
Glasgow Coma Scale score
Time frame
At 72±12 hours and 7±1 days after randomization4
Early neurological deterioration
Early neurological deterioration is defined as a decrease of ≥2 in GCS score or an increase of ≥4 in NIHSS score caused by non-sedatives/sleeping drugs compared with the baseline level.
Time frame
At 72±12 hours and 7±1 days after randomizationOther outcomes
1
Changes in the levels of venous neuroinflammation indicators compared with baseline levels
Venous neuroinflammation indicators (IL, TNF-α, TGF-β, NFL, etc.)
Time frame
At 72±12 hours and 7±1 days after randomization2
Perihematomal blood-brain barrier permeability
Perihematomal blood-brain barrier permeability is assessed using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
Time frame
At 7±1 days after randomization3
Hematoma expansion or rebleeding
Hematoma expansion or rebleeding
Time frame
At 72±12 hours and 7±1 days after randomization4
Antibiotic-associated diarrhea, enteritis, and constipation
Antibiotic-associated diarrhea, enteritis, and constipation
Time frame
At 7±1 days after randomizationSponsors and contacts
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Source ClinicalTrials.gov