Dan Dong Shi

Acute ischemic stroke is a leading cause of death worldwide, and intravenous thrombolysis with recombinant tissue plasminogen activator rt-PA within 4.5 hours of symptom onset is the most effective treatment currently available. However, some patients experience stroke progression and early reocclusion after thrombolysis, which can worsen neurological outcomes. This trial evaluates whether early antiplatelet therapy with oral aspirin, given soon after thrombolysis, can improve recovery without increasing bleeding risks. The study randomly assigns patients to receive either early oral aspirin within 3 hours of starting intravenous thrombolysis or a placebo, alongside the best medical care based on current guidelines. Aspirin is administered as a 300 mg dose, either chewed or given via nasogastric tube if swallowing is difficult. The trial includes a control group receiving placebo under similar conditions to compare outcomes. This is a Phase 3, multicenter, quadruple-blind, randomized clinical trial. During the study, participants will be closely monitored for neurological status and functional recovery using the modified Rankin scale at 30 and 90 days after stroke, as well as other assessments like NIH Stroke Scale scores within the first week. Researchers will track early neurological changes and safety outcomes such as intracranial hemorrhage. Follow-up will include evaluations at multiple time points up to 90 days post-stroke to determine the effects of early antiplatelet treatment on stroke recovery.

Post-stroke cognitive impairment PSCI is a condition where cognitive problems occur after a stroke and last for at least 24 weeks. It includes mild cognitive issues without dementia PSCIND and more severe dementia PSD. PSCI affects a significant number of stroke survivors and is linked to higher mortality. Current guidelines recommend early intervention to prevent progression, but more research is needed to see if cognitive-enhancing drugs can reduce PSCI risk and improve outcomes. This trial studies the drug dl-3-butylphthalide in patients aged 60 and older who have had an acute ischemic stroke. The study includes two stages over 48 weeks. In the first 24 weeks, participants receive either dl-3-butylphthalide or a placebo along with standard stroke treatments. After a 14-day washout, during the next 24 weeks, all patients receive donepezil plus either dl-3-butylphthalide or placebo to assess improvements in cognitive function. Participants will undergo cognitive assessments and brain MRI scans at baseline, 24 weeks, and 48 weeks. Researchers will measure PSCI occurrence at 24 weeks and changes in cognitive scores like VADAS-Cog, MoCA, MMSE, and others. Additional evaluations include neuropsychiatric symptoms, anxiety, depression, daily living activities, stroke recurrence, and functional status. The study is randomized, double-blind, placebo-controlled, and aims to evaluate the effects of dl-3-butylphthalide on cognitive changes after stroke.

Researchers are evaluating the efficacy and safety of oral minocycline in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of onset. This prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial aims to improve patient outcomes and explore the effects of minocycline on venous neuroinflammation in this condition. Participants will be randomly assigned to receive either minocycline or a matching placebo for 5 days alongside standard medical care. The minocycline group will take an initial dose of 200 mg immediately after randomization, followed by 100 mg every 12 hours for a total of 10 doses. Those with swallowing difficulties may receive the medication through a nasal feeding tube. The trial includes screening, treatment, and follow-up phases with visits scheduled at screening, 72 hours, 7 days, 90 days, and 180 days after randomization. During the study, participants will undergo assessments including neurological evaluations and imaging at specified time points. Researchers will measure outcomes such as the modified Rankin Scale score at 90 days, changes in neurological scores, inflammation markers, and stroke recurrence. Safety and efficacy will be monitored through these evaluations, with total participation lasting up to 180 days post-randomization.

Researchers are evaluating the safety and effectiveness of Yangxinshi tablets in patients with coronary heart disease combined with cardiac dysfunction. This study aims to determine if adding Yangxinshi tablets to standard treatment can reduce heart-related events, enhance exercise capacity, and improve quality of life and mental health. The trial includes 2708 patients and is a Phase 4 randomized controlled study sponsored by SPH Qingdao Growful Pharmaceutical Co., Ltd. Participants are randomly assigned to one of two groups one group receives conventional treatment plus Yangxinshi tablets 3 tablets taken orally three times a day, while the control group receives conventional treatment alone. Conventional treatment includes drugs such as aspirin, beta-blockers, statins, and others for symptom relief and improving heart outcomes. The treatment continues until a set number of heart-related events occur or the study ends. Throughout the study, participants undergo regular assessments including measurements of heart events, exercise tolerance, heart function tests, blood markers, and mental health questionnaires over an average of three years. Additional evaluations at 24 and 48 weeks include depression and anxiety scales, echocardiography, and exercise testing. The research team closely monitors safety, quality of life, and heart function throughout the study period.

Researchers are evaluating Shuxuening injection, a multi-target neuroprotective agent, to see its effects when added to intravenous thrombolysis therapy in patients with acute ischemic stroke. This large, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness and safety of Shuxuening injection in improving outcomes after stroke. Intravenous thrombolysis with rt-PA is the current standard treatment, but many patients still experience significant disability, so neuroprotective agents like Shuxuening may help reduce brain cell death. Participants will be randomly assigned to one of two groups one group will receive Shuxuening injection combined with intravenous thrombolysis, and the other will receive a placebo combined with intravenous thrombolysis. Both treatments involve a daily intravenous drip of 20 ml Shuxuening or placebo plus 250 ml of 0.9% sodium chloride for 10 to 14 days. The study plans to enroll 1380 patients within 6 hours of stroke onset from 50 centers across China. During the study, participants will be monitored closely with assessments including the modified Rankin Scale mRS score at 90 days to measure functional recovery, along with safety monitoring for adverse events over 90 days. Other evaluations include neurological function scores, quality of life surveys, and various safety outcomes. The trial will last for at least 90 days after treatment, with data collected on disability, recovery, and any side effects experienced.