Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT07088250
Brief Summary:
The STOP ICH trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the efficacy and safety of atorvastatin in patients with intracerebral hemorrhage (ICH) presenting within 3 to 24 hours of symptom onset.
Detailed Description:
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) clinical trial aimed at evaluating the efficacy and safety of atorvastatin in patients with spontaneous intracerebral hemorrhage (ICH). Eligible participants include adults aged 18 to 80 years presenting with spontaneous ICH who are enrolled within 3 to 24 hours from symptom onset or the last known well time, provided they meet all inclusion criteria and no exclusion criteria. A total of 264 patients will be randomized in a 1:1 ratio into two treatment arms: the control group, receiving best medical treatment (BMT) in accordance with current ICH guidelines, and the experimental group, receiving BMT plus atorvastatin at a dosage of 20 mg once daily for 21 consecutive days. The primary objective is to determine whether atorvastatin improves clinical outcomes in patients with ICH. The primary efficacy endpoint is the proportion of patients with a poor functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 4 to 6.
Study:
NCT07088250
Study Brief:
Protocol Section:
NCT07088250