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Found 5 Actively Recruiting clinical trials
Actively Recruiting
People with end stage kidney disease ESKD who require dialysis face a much higher risk of cardiovascular disease compared to the general population, with cardiac issues causing 58% of deaths in this group. However, while aspirin is known to reduce cardiovascular problems in the general population, there is limited evidence about its effects in dialysis patients. The ASPIrin to Reduce Event in Dialysis ASPIRED trial aims to study whether taking low-dose aspirin can safely improve cardiovascular outcomes in people with ESKD receiving dialysis. This study is a multi-center, double-blind, randomized controlled trial that will compare daily low-dose aspirin 100 mg to a placebo pill in patients undergoing dialysis. The trial uses an existing dialysis registry platform to screen, recruit, and collect data during routine clinical care, minimizing participant burden and study costs. Randomization is managed through a secure web-based system, and follow-up visits occur every six months as part of regular clinic visits. The trial is expected to last approximately five years and includes oversight by an independent safety and monitoring board. Participants will be involved in regular six-monthly clinic visits where their health will be monitored as part of their usual dialysis care. Researchers will track the occurrence of major cardiovascular events, including heart attacks, strokes, vascular complications, and deaths, throughout the study period. Data will be collected from routine clinical procedures and the dialysis registry to evaluate outcomes. Safety and efficacy will be closely monitored, and the study will follow participants for up to five years to assess the long-term effects of aspirin use in this population.
Actively Recruiting
Researchers are investigating the effects of amlodipine alone versus amlodipine combined with folic acid in Chinese adults aged 45 to 74 years who have H-type hypertension, specific MTHFR 677 genotypes CC or CT, elevated plasma homocysteine levels, and low serum folate. This large, multi-center, randomized, double-blind, double-dummy clinical trial aims to evaluate which treatment better reduces the risk of first ischemic stroke over five years. Participants are first screened and then enter a 2 to 4 week run-in period where they take amlodipine to assess tolerance and compliance. Afterward, eligible participants are randomized by genotype into two groups one receiving amlodipine 5mg daily with a placebo, and the other receiving amlodipine 5mg combined with 0.8mg folic acid daily with a placebo. Other blood pressure medications may be added as needed to reach target blood pressure goals. Follow-up visits occur every three months during the five-year treatment period with medication provided at each visit. Throughout the study, participants undergo interviews, clinical evaluations, and laboratory tests including genetic and blood analyses. Researchers monitor adherence, blood pressure, and cardiovascular health. The main outcome measured is the occurrence of first ischemic stroke by the end of five years. Secondary outcomes include other cardiovascular events and kidney function. Two interim analyses will be conducted during the study to assess progress and safety.
Actively Recruiting
Researchers are evaluating the effects of different amlodipine-based treatments on the risk of first ischemic stroke in Chinese adults aged 45 to 74 years with hypertension and the MTHFR 677 TT genotype. This large, multi-center, randomized, double-blind, triple-dummy controlled trial aims to compare amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate over a 5-year period. The study focuses on preventing ischemic stroke as the primary outcome. Participants first undergo a screening period to confirm eligibility through interviews, clinical evaluations, and lab tests. Those who qualify enter a 2 to 4 week run-in phase with daily amlodipine to check treatment tolerance and compliance. Eligible participants are then randomly assigned to one of three daily oral treatment groups amlodipine alone, amlodipine folic acid, or amlodipine folic acid plus 5-MTHF. Additional antihypertensive medications may be added as needed to control blood pressure. Participants are followed every 3 months for drug distribution and monitoring. Throughout the study, participants will have regular clinical visits, interviews, and biological sample collections to monitor health and treatment effects. Researchers will track the incidence of first ischemic stroke and other cardiovascular and kidney outcomes over five years. Safety and treatment adherence are carefully observed, with two planned interim analyses during the trial. Total participation spans from initial screening through five years of treatment and follow-up.
Actively Recruiting
Researchers are evaluating the use of oral Vonoprazan, a potassium-competitive acid blocker, compared to standard high dose proton pump inhibitor PPI therapy for patients with bleeding peptic ulcers who have received successful endoscopic haemostasis. This multicenter randomized controlled trial aims to determine whether Vonoprazan is not worse than the standard intravenous PPI infusion at preventing recurrent bleeding within 30 days. Upper gastrointestinal bleeding remains a serious condition, and effective acid suppression helps stabilize clots and prevent further bleeding. Participants will be randomly assigned to receive either a high dose PPI infusion consisting of an 80mg intravenous bolus of esomeprazole followed by continuous infusion at 8mg per hour for 72 hours, or oral Vonoprazan at 40mg twice daily for 72 hours followed by 20mg daily from day 4 to day 30. The study compares these two acid suppression methods after endoscopic treatment to assess their effects on recurrent bleeding and related outcomes. During the study, participants will be monitored for recurrent bleeding, need for additional hemostatic treatment, and length of hospital and intensive care stay within 30 days after randomization. Researchers will also investigate Vonoprazans effect on intragastric pH in this clinical setting. The total participation time includes treatment and follow-up assessments extending to 30 days after starting the assigned therapy.
Actively Recruiting
Researchers are evaluating the use of manual thrombus aspiration TA during primary percutaneous coronary intervention PPCI in patients who have experienced an ST-segment Elevation Myocardial Infarction STEMI with a high thrombus burden. The study aims to determine if including TA can reduce major adverse cardiovascular events such as cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days, or stroke within 30 days. This is a prospective, multicenter, open-label, randomized controlled trial. Participants are randomly assigned to one of two groups one receiving upfront manual thrombus aspiration followed by PCI, and the other undergoing PCI without the use of manual thrombus aspiration. The treatment is delivered during the primary PCI procedure within 12 hours of symptom onset. The study compares these two approaches to assess their impact on patient outcomes. Throughout the study, participants will be monitored for major adverse cardiovascular events up to 180 days after treatment, with additional tracking of stroke occurrences up to 30 days and composite adverse cardiocerebrovascular events up to one year. Researchers will collect data on safety and efficacy as part of the follow-up period. The trial is led by Guangdong Provincial Peoples Hospital and does not include blinding, with a planned end date in February 2026.