Dan Dong Shi

Stroke is the second leading cause of death worldwide, with ischemic stroke being the most common type. The current best treatment for acute ischemic stroke is intravenous thrombolysis using recombinant tissue plasminogen activator (rt-PA) given within 4.5 hours of symptom onset. However, some patients experience stroke progression or early blood vessel reocclusion after thrombolysis, which worsens neurological function and outcomes. This is believed to be caused by increased platelet activation after thrombolysis, which peaks within the first 2 hours. This clinical trial is testing whether starting oral aspirin early after intravenous thrombolysis can improve functional outcomes without causing more bleeding problems. Patients are randomly assigned to receive either 300 mg aspirin tablets or matching placebo tablets as soon as possible after enrollment. If swallowing is difficult, tablets can be crushed and given through a nasogastric tube. Both groups receive best medical management according to guidelines. The study is a Phase 3, multicenter, randomized, placebo-controlled trial. Participants will be followed for 90 days after stroke to measure their functional recovery using the modified Rankin scale (mRS). Researchers will check if patients have a good outcome defined as an mRS score of 0 or 1 at 90 days. During the study, patients undergo assessments including neurological exams and imaging to confirm eligibility and monitor safety. The trial aims to determine if early aspirin treatment after thrombolysis is safe and can help prevent neurological decline and improve recovery.

Post-stroke cognitive impairment (PSCI) is a condition where cognitive problems continue for at least 24 weeks after a stroke. It includes different levels of severity, such as post-stroke cognitive impairment without dementia and post-stroke dementia. Studies show that PSCI affects a significant number of stroke survivors and increases the risk of death. Current guidelines recommend early intervention to delay or prevent worsening cognitive decline, but more research is needed to confirm if cognitive-enhancing drugs can help. This trial aims to evaluate the effects of donepezil in treating PSCI in a phase 3, randomized, double-blind, placebo-controlled study. The study involves two stages over a total of 48 weeks. In the first 24 weeks, participants receive routine stroke care along with either butylphthalide capsules or placebo capsules taken three times daily on an empty stomach. After a 14-day washout period, the second stage lasts another 24 weeks where all participants receive donepezil (5-10 mg daily) plus either butylphthalide or placebo capsules three times daily. The study compares cognitive outcomes between groups to see if donepezil combined with butylphthalide improves cognition better than routine treatment with placebo. Participants will undergo cognitive assessments, physical exams, MRI scans, and questionnaires throughout the study. The main outcomes measured are the rate of PSCI at 24 weeks and cognitive scores after 6 months. Adherence to study medications and safety will be monitored regularly. Total participation lasts 48 weeks, with close follow-up to evaluate both prevention and improvement of cognitive impairment after stroke.

Researchers are investigating the effectiveness and safety of oral minocycline compared to placebo in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of symptom onset. This phase III clinical trial is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study aiming to improve recovery outcomes in this patient population. An additional goal is to assess the impact of minocycline on markers of venous neuroinflammation at various times after the hemorrhage. A total of 1192 participants will be randomly assigned in equal numbers to receive either minocycline capsules containing 50 mg of minocycline hydrochloride or matching placebo capsules for five days. All participants will also receive standard medical care based on current guidelines. The study includes three phases: screening and baseline, treatment, and follow-up. Participants will be evaluated at several time points including screening/baseline, 72 ±12 hours, 7 ±1 days, 90 ±7 days, and 180 ±7 days after randomization, as well as during any relevant events. Researchers will measure the primary outcome of disability and functional status using the modified Rankin Scale score (mRS) at 90 days post-randomization, aiming for scores between 0 and 3. Throughout the study, assessments and interviews will monitor safety, efficacy, and treatment adherence.

Researchers are evaluating the efficacy and safety of Yangxinshi tablets in patients with coronary heart disease complicated by cardiac dysfunction. This Phase 4 randomized controlled trial aims to determine whether adding Yangxinshi tablets to conventional treatment can reduce ischemic or heart failure-related clinical events, improve exercise tolerance, and enhance quality of life and mental health in these patients. The study includes 2708 patients aged 40 to 80 years with specific heart conditions and symptoms. Participants are randomly divided into two groups: one group receives conventional treatment plus Yangxinshi tablets (3 tablets, three times daily), while the control group receives only conventional treatment without additional tablets. Conventional treatment includes drugs such as aspirin, beta-blockers, statins, and others aimed at improving outcomes and relieving symptoms. The treatment continues until the expected number of endpoint events occurs or the study ends. During the study, participants are monitored for ischemic events or heart failure-related clinical events, including death, stroke, myocardial infarction, and hospital readmissions. The average follow-up period is about three years. Researchers assess exercise tolerance, quality of life, and mental health, while monitoring safety and overall health status throughout the study.

Researchers are evaluating the efficacy and safety of Shuxuening injection as an additional treatment to intravenous thrombolysis in patients with acute ischemic stroke. This multicenter, randomized, double-blind, placebo-controlled phase 3 trial involves patients aged 18 to 100 years who have experienced an ischemic stroke and can be treated within 6 hours of symptom onset. The study aims to improve functional outcomes by reducing brain cell death after stroke using this multi-target neuroprotective agent alongside the standard clot-busting therapy. Participants are randomly assigned in a 1:1 ratio to receive either Shuxuening injection or a placebo. Both groups receive a daily intravenous drip of 20 ml of the study drug or placebo combined with 250 ml of 0.9% sodium chloride injection for 10 to 14 days. The treatment starts as soon as possible after intravenous thrombolysis therapy, and the study compares these two groups to assess differences in recovery and safety. During the trial, researchers will monitor participants for 90 days after randomization. They will assess the primary outcome by measuring the proportion of patients achieving a modified Rankin Scale (mRS) score of 0 to 1, indicating good functional recovery. Safety will be evaluated by tracking adverse events over the same 90-day period. Participants will be closely followed with clinical evaluations to understand the effects and tolerability of Shuxuening injection in stroke recovery.