drugset / Trial / NCT07252544
Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)
Phase 3
Not yet recruiting
3156 enrolled
Beijing Tiantan Hospital
Shenzhen Second People's Hospital · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
The goal of this multicenter, double-blind, 2×2 factorial randomized controlled trial is to evaluate the efficacy and safety of isosorbide mononitrate, butylphthalide, and their combination in reducing disability in patients with acute lacunar stroke.
Timeline
- Start
- 2025-12-01
- Primary completion
- 2027-08-31
- Completion
- 2028-02-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Butylphthalide | Small molecule | 200 mg | Intravenous |
| Subject | Isosorbide Mononitrate | Other / unclassified | 40 mg | Intravenous |