Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Hospital of Jilin University

About this trial

This study plans to enroll 1248 patients with supratentorial ICH within 24 hours of onset across multiple stroke centers. After randomization, the control group will only receive medical therapy. The experimental group, after randomization, will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical ttherapy, followed by 100 mg orally every 12 hours for 7 days, resulting in a total of 14 administrations. Both groups will be followed for 180 days to evaluate the efficacy and safety of minocycline in the treatment of ICH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, regardless of gender;

Supratentorial ICH confirmed by brain CT scan;

No disability in the community before ICH (premorbid mRS≤1);

Neurological deficits related to the hematoma, with NIHSS score ≥ 6 and single-limb motor item score ≥ 2;

Disqualifiers

Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, use of thrombolytic drugs;

Allergy to tetracycline antibiotics;

Use of vitamin A derivatives or steroid therapy within the past 3 months;

Concomitant infection requiring antibiotic treatment at admission;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minocycline

    Drug

    The experimental group will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical therapy after randomization, followed by 100 mg orally every 12 hours for 7 days, totaling 14 administrations.

Treatment groups

1,248 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The proportion of patients with favorable functional outcomes, defined as mRS 0-2 at 180 days.

Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Time frame
180 days

Secondary outcomes

1

The proportion of patients with an mRS score of 0-1 at 180 days.

Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Time frame
180 days
2

The proportion of patients with favorable functional outcome (mRS score of 0-2) at 90 days.

Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Time frame
90 days
3

The proportion of patients with an mRS score of 0-1 at 90 days.

Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Time frame
90 days
4

The distribution of mRS scores at 90 days and 180 days.

Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Time frame
90 days and 180 days

Other outcomes

1

The incidence of any adverse events during the study period.

Adverse events.

Time frame
180 days
2

The incidence of serious adverse events during the study period.

Serious adverse events.

Time frame
180 days
3

The incidence of minocycline-related adverse events during the study period.

Minocycline-related adverse events.

Time frame
180 days
4

Mortality during the study period.

Mortality.

Time frame
180 days

Locations

This trial has no locations.

Sponsors and contacts

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