Yang Jiang Shi

People with end stage kidney disease (ESKD) who require dialysis have a much higher risk of developing cardiovascular disease compared to the general population, with heart problems causing over half of the deaths in this group. This trial is studying whether taking low dose aspirin daily can safely reduce cardiovascular events in these dialysis patients. The study is a Phase 4, multi-center, randomized controlled trial designed to provide clear evidence about aspirin's benefits and risks in this specific population, where existing data is limited. Participants will be randomly assigned to receive either a daily 100 mg aspirin tablet or a matching placebo. The trial uses the Chinese peritoneal dialysis and hemodialysis registry to efficiently screen and recruit patients and collect data during routine dialysis care. Follow-up visits occur every six months as part of regular clinical care, and the study will continue until enough cardiovascular events have occurred, expected to take about five years. During the study, participants will have their health monitored through routine clinic visits every six months, with data collected on cardiovascular events and safety. The main outcome measured is the number of participants experiencing major cardiovascular events over the study period. An independent board will oversee safety and study progress. The trial uses intention-to-treat analysis and aims to minimize participant burden by integrating study procedures into usual care.

Researchers are evaluating the effects of two treatments in people with H-type hypertension who have specific genetic types (MTHFR 677 CC or CT), elevated plasma homocysteine levels, and low serum folate. This large, phase 4 clinical trial involves 32,000 Chinese men and women aged 45 to 74 years. The study aims to compare the risk of first ischemic stroke over a five-year period between the two treatment groups. Participants will be divided into groups based on their MTHFR genotype and randomly assigned to receive either amlodipine tablets (5mg once daily) or amlodipine combined with folic acid tablets (5.8mg once daily). The study includes a screening period, a 2 to 4-week run-in phase to check tolerance and compliance to amlodipine, and a five-year randomized treatment phase. Additional blood pressure medications may be added if needed to maintain target blood pressure levels. During the study, participants will have visits every three months for drug distribution and monitoring. Researchers will collect blood samples, conduct clinical evaluations, and gather data on medication adherence and health outcomes. The primary outcome measured is the first occurrence of ischemic stroke by the end of five years. Safety and efficacy will be assessed, with two interim analyses planned at years three and four.

Researchers are studying the effects of three different treatment approaches on the risk of first ischemic stroke in Chinese men and women with hypertension and a specific genetic type called MTHFR 677 TT genotype. This large, phase 4 clinical trial will include 24,000 participants aged 45 to 74, and will compare the impact of amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate (5-MTHF). The goal is to evaluate which treatment strategy might better prevent the first ischemic stroke over five years. The study has three main periods: screening, run-in, and randomized treatment. During screening, participants provide consent and undergo interviews, clinical evaluations, and lab tests to confirm eligibility. The run-in period lasts 2 to 4 weeks, where participants take amlodipine (5 mg once daily) to assess tolerance and compliance. After this, eligible participants are randomly assigned to one of three groups: amlodipine only, amlodipine plus folic acid, or amlodipine plus folic acid and 5-MTHF. Treatments are taken orally once daily for five years. Additional antihypertensive medications may be added as needed to keep blood pressure controlled. Participants will visit the research centers every three months for follow-up, medication distribution, and monitoring. Researchers will check blood pressure, collect biological samples, and assess compliance and safety throughout the five-year treatment. The study’s main outcome is the occurrence of a first ischemic stroke by the end of the fifth year. Two interim analyses are planned at years three and four to evaluate ongoing results while maintaining study integrity.

Researchers are evaluating the effectiveness of Vonoprazan, an oral potassium-competitive acid blocker, compared to the standard high-dose proton pump inhibitor (PPI) therapy for treating bleeding peptic ulcers. This phase 4 multicenter randomized controlled trial addresses upper gastrointestinal bleeding, a serious medical emergency, focusing on preventing recurrent bleeding after successful endoscopic haemostasis. While Vonoprazan has been studied for reflux esophagitis and gastric ulcers, there is limited data on its use specifically for bleeding peptic ulcers. Participants will receive one of two treatments: oral Vonoprazan or a high-dose PPI infusion. The Vonoprazan group takes 40 mg twice daily for 72 hours, then 20 mg daily from day 4 to 30. The PPI group receives an 80 mg intravenous bolus of esomeprazole followed by continuous infusion at 8 mg per hour for 72 hours, then oral esomeprazole daily from day 4 to 30. This dosing aims to compare the acid-suppressing effects of both treatments in preventing recurrent bleeding. During the study, participants will be monitored for recurrent bleeding within 30 days after randomization. Assessments include endoscopic haemostasis success, clinical evaluation of bleeding signs, and safety monitoring. The study also investigates Vonoprazan's effect on intragastric pH. Participants will be followed for up to 30 days to evaluate treatment outcomes and adverse effects.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of HB0017 Injection in adults with moderate to severe plaque psoriasis. Participants must have chronic plaque psoriasis lasting at least 6 months, with significant disease severity measured by PASI and body surface area affected. Participants are assigned to one of three groups: receiving HB0017 injection every 4 weeks after initial doses at weeks 0, 1, 2, 4, and 8; HB0017 injection every 8 weeks after the same initial dosing schedule; or placebo injections following the initial doses and then switching to HB0017 every 4 weeks. Treatment is administered via biological injections according to these schedules. Throughout the study, researchers will monitor participants to determine the proportion achieving a 75% improvement in the Psoriasis Area Severity Index (PASI 75) and the proportion reaching a static Physician Global Assessment (sPGA) score of 0 or 1 at week 12. Safety, immune response, drug levels, and effects on the disease will also be assessed. The study includes adults aged 18 to 75 years and tracks treatment outcomes and adverse events over the duration of the trial.

Researchers are investigating the effects of thrombus aspiration (TA) in patients experiencing ST-segment Elevation Myocardial Infarction (STEMI) who have a high thrombus burden, indicated by a TIMI thrombus grade of 3 or higher. This prospective, multicenter, open-label, randomized controlled trial aims to compare outcomes between patients treated with or without manual thrombus aspiration during primary percutaneous coronary intervention (PPCI) performed within 12 hours of symptom onset. The goal is to assess if TA reduces major cardiovascular events including cardiovascular death, recurrent heart attacks, stent thrombosis, target vessel revascularization within 180 days, or stroke within 30 days. Participants are randomly assigned in a 1:1 ratio to receive either primary PCI with manual thrombus aspiration or PCI alone without thrombus aspiration. Both procedures are performed as part of the treatment for STEMI patients with high thrombus burden. The study evaluates the safety and efficacy of adding thrombus aspiration to the standard PCI process. During the study, patients will be monitored for up to 180 days to track the occurrence of major adverse cardiovascular events. Researchers will collect data on cardiovascular death, recurrent myocardial infarction, stent thrombosis, need for target vessel revascularization, and stroke. Follow-up evaluations will help determine the overall impact of thrombus aspiration on patient outcomes after STEMI treatment.