Qi Qi Ha Er Shi

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

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.

Researchers are evaluating lunsekimig, a subcutaneous injection, compared with placebo in adults aged 40 to 80 years with inadequately controlled Chronic Obstructive Pulmonary Disease COPD characterized by an eosinophilic phenotype. This Phase 2bPhase 3 parallel study aims to assess the efficacy, safety, and tolerability of lunsekimig in reducing COPD exacerbations and improving lung function and symptoms. Participants are randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. They will receive subcutaneous injections during a 48-week treatment period. The study also includes a screening period of up to 4 weeks before treatment and an approximately 8-week follow-up period after treatment, totaling up to 60 weeks of participation. During the study, participants will undergo regular assessments including lung function tests such as post- and pre-bronchodilator Forced Expiratory Volume in 1 second FEV1, questionnaires measuring respiratory health and symptoms, and monitoring of COPD exacerbations. Safety will be evaluated through reported adverse events and laboratory tests. Researchers will also monitor blood levels of lunsekimig and the presence of antidrug antibodies. Participants will be followed closely throughout the study duration to assess treatment impact and safety.

Researchers are evaluating the efficacy and safety of orelabrutinib in adults with systemic lupus erythematosus SLE who are already receiving standard care treatments. This phase IIb study is randomized, double-blind, placebo-controlled, and conducted at multiple centers to better understand how well orelabrutinib works and how safe it is for this population. Participants are assigned to one of three groups receiving either a low dose of orelabrutinib, a high dose of orelabrutinib, or a placebo. All treatments are taken orally once daily alongside standard of care therapy. The study lasts 48 weeks, with assessments continuing up to 52 weeks to monitor safety and treatment responses. During the trial, participants will have regular evaluations measuring their response to treatment using tools like the SLE Responder Index and assessments of lupus flare timing. Researchers will also track changes in health surveys, antibody levels, and medication use. Safety is closely monitored through reports of adverse events, with the full study duration extending slightly beyond the treatment period for follow-up.

Researchers are conducting a prospective, multicenter, open-label, randomized controlled trial to compare two treatment strategies for adults with acute myocardial infarction AMI who have mild coronary artery narrowing. The study aims to determine if standard medical therapy alone is not worse than using drug-eluting stent DES implantation combined with standard therapy. This trial will include 2,000 patients with ST-segment elevation myocardial infarction STEMI or non-ST-segment elevation myocardial infarction NSTEMI from multiple centers in China. Participants will be randomly assigned to one of two groups one receiving guideline-recommended standard medical therapy alone, which includes dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other related medications and the other receiving DES implantation plus the same standard medical therapy. The study also includes a functional substudy with 120 participants assessing coronary microvascular dysfunction using pressure wire tests. The enrollment period is planned for 36 months, with a follow-up of at least 12 months after randomization and continued monitoring until study completion. During the study, participants will undergo coronary angiography and assessments of vessel function. Researchers will monitor for target lesion failure TLF, defined as cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, over a median follow-up of 30 months. Additional outcomes include all-cause death, stroke, rehospitalization for heart conditions, and quality of life measures. The study tracks these outcomes through regular follow-up visits to evaluate the safety and effectiveness of the treatment approaches.

Researchers are evaluating the drug Kylo-11 in adults with atherosclerotic cardiovascular disease ASCVD who also have elevated levels of lipoproteina, a condition related to cardiovascular risk. This phase 2, double-blind, randomized, placebo-controlled study aims to find the effective dose and assess the safety of Kylo-11 compared to a placebo in this population. Participants will receive one of three different doses of Kylo-11 or a matched placebo, all administered by injection under the skin subcutaneously. The study is conducted across multiple centers with participants randomly assigned to one of the treatment groups. The treatment period includes monitoring of changes in lipoproteina levels over various weeks to assess the drugs impact. During the study, participants will have regular assessments including measuring lipoproteina levels at baseline and throughout weeks 8 to 52. Researchers will also track the proportion of participants achieving specific target levels of lipoproteina. Safety and efficacy will be closely monitored, with the primary focus on the percent change in lipoproteina from baseline during the treatment period. The total study duration extends until 2028 with primary completion expected by early 2027.

Researchers are evaluating the safety and effectiveness of TQC2731 injection in adults with severe asthma that is not well controlled. This is a Phase III clinical trial where 660 participants with asthma are randomly assigned to receive either TQC2731 or a placebo. The study aims to see if TQC2731 can reduce asthma worsening episodes over one year compared to placebo. Participants receive either the TQC2731 injection or placebo every four weeks for up to 48 weeks through subcutaneous injection. The treatment cycles repeat monthly from the start until Week 48. The study compares these two groups to assess the impact on asthma symptoms and lung function. Throughout the trial, participants will have regular assessments including lung function tests, asthma symptom diaries, quality of life questionnaires, and blood tests for inflammation markers and immune response. Researchers track the number of asthma exacerbations during the 52 weeks of treatment and up to 64 weeks for some outcomes. Safety and immune reactions are monitored carefully. The total study duration for each participant is about one year of treatment plus follow-up.

Researchers are evaluating treatments for adults with acute spontaneous supratentorial intracerebral hemorrhage ICH of 20mL or more. This trial compares early minimally invasive surgery combined with thrombolysis eMIST to best medical management. The goal is to assess which approach improves functional outcomes after stroke, measured by a blinded evaluation at 180 days using the modified Rankin Scale. Participants are randomly assigned to one of two groups one receives minimally invasive catheter evacuation followed by up to 10 doses of urokinase to help dissolve the clot the other group receives standard medical care. The intervention is given early after stroke onset, with randomization within 8 hours and treatment started within 4 hours after randomization. The study uses an adaptive design with ongoing assessment of sample size and outcomes. During the study, participants undergo assessments including brain imaging, functional outcome scales, and quality of life questionnaires at multiple time points up to 180 days. Researchers will monitor clot removal, mortality, daily living activities, and health-related quality of life. The trial includes follow-up visits to evaluate recovery and safety over time, supporting a thorough understanding of treatment effects and participant progress.