Clinical trial

Efficacy of Minocycline in Improving Neurological Outcomes of Patients Who Undergo Endovascular Revascularization for Acute Ischemic Stroke

Name
STUDY00006145
Description
The study will be a prospective, randomized, double- blinded placebo, single center pilot clinical trial. Patients with acute ischemic stroke due to large vessel occlusion undergoing endovascular thrombectomy will be included. The treatment group will receive 200 mg intravenous/oral minocycline hydrochloride in addition to endovascular thrombectomy for a total of 21 days. The control group will receive standard medical and endovascular care along with a similar looking placebo. Patients will be randomized to the treatment or control group by the Pharmacy eliminating the selection bias. The patient and evaluator will be blind to the allocation of patients further minimizing the bias. Through randomization we expect to achieve two groups that are comparable in their baseline clinical characteristics.
Trial arms
Trial start
2024-12-01
Estimated PCD
2025-03-01
Trial end
2026-06-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Minocyclin
200 mg intravenous/oral minocycline hydrochloride for a total of 21 days
Arms:
Intervention
Other names:
Minocycline HCL 200mg Daily (Oral or Intravenous)
Size
134
Primary endpoint
mRS at 90-days
90 days post op
Eligibility criteria
Inclusion Criteria: 1. provision of consent, either by self or authorized representative, willingness and ability to participate in study procedures 2. Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia 3. Age more than 18 years 4. Premorbid Rankin score ≤ 3 5. Treatment with intra-arterial endovascular revascularization methods. 6. Patients should be given first dose of minocycline as soon as possible, latest by 24 hours after the endovascular stroke intervention Exclusion Criteria: 1. Allergy/ Intolerance to tetracycline antibiotics 2. Pregnant women - positive pregnancy test on admission or known to be pregnant 3. ALT or AST \> 3 times the upper limit of normal 4. Serum creatinine \> 2 mg/dL 5. Patient is participating in another clinical trial at any time during the duration of the study that could confound the treatment or outcomes of this investigation; and/or 6. Has a severe health condition that may potentially result in death within 6 months.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study will be a prospective, randomized, double- blinded placebo, single center pilot clinical trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 134, 'type': 'ESTIMATED'}}
Updated at
2024-02-08

1 organization

1 product

1 indication

Product
Minocyclin
Indication
Stroke