Overview

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

Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
State University of New York at Buffalo
Treatments:
Minocycline
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.