Efficacy and Safety of Mildronate for Acute Ischemic Stroke: Study Protocol for a Randomized, Double-blind, Placebo-controlled Phase II Multicenter Trial
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- the modified Rankin scale
Study Overview
Brief Summary
This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke
Detailed Description
a randomized, double-blind, placebo-controlled phase II multicenter trial is conducted to evaluate the efficacy and safety of mildronate injection in patients with acute ischemic stroke. patients will be randomized to receive a 14-day treatment of placebo or mildronate (500mg/5ml/each).Primary end-point is the modified Rankin scale at 3 monthes. Secondary end-point is the NIHSS scores and the Barthel index at 8 days and 15days. The safety end-point is defined as the incidence of adverse events, the change of Samples for routine laboratory tests and vital signs. Analysis is by intention to treat.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5~22 on the first stage
Exclusion Criteria
- •have other intracranial pathologies are pregnant or nursing have significant drug or alcohol misuse have been in a clinical trial in the past 3 months are unlikely to be available for follow-up have been given thrombolytic therapy or medication forbidden by study protocol have a neurological or psychiatric disease
Arms & Interventions
mildronate
infusion of mildronate
Intervention: infusion of mildronate (Drug)
mildronate
infusion of mildronate
Intervention: aspirin (Drug)
placebo
infusion of placebo mildronate
Intervention: placebo (Drug)
placebo
infusion of placebo mildronate
Intervention: aspirin (Drug)
Outcomes
Primary Outcomes
the modified Rankin scale
Time Frame: 3 months
Secondary Outcomes
- NIHSS scores(15 days)
- the Barthel index(15 days)