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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effects of dexmedetomidine DEX on heart damage size in patients who have experienced an anterior ST-segment elevation myocardial infarction STEMI and are undergoing primary percutaneous coronary intervention pPCI within 6 hours of symptom onset. This double-blind, randomized, placebo-controlled trial aims to determine if DEX can reduce myocardial infarct size compared to a placebo. The trial plans to enroll 250 patients to achieve reliable results. Participants are randomly assigned to either the DEX group or the placebo group in a 11 ratio. Those in the DEX group receive an intravenous infusion starting immediately upon enrollment, with doses adjusted between 0.2 to 0.7 gkgh based on heart rate, blood pressure, and sedation scores, continuing throughout the PCI procedure. The placebo group receives saline infusions following the same schedule and dose adjustments. This treatment phase occurs during the PCI operation. During the study, patients undergo cardiac magnetic resonance imaging CMR about 5 days after STEMI to measure myocardial infarct size and other heart function indicators. Additional evaluations include blood tests for heart damage markers at multiple time points after PCI and echocardiography at 30 days. Researchers track major adverse cardiovascular events up to 12 months post-STEMI. Total participation includes initial treatment and follow-up assessments over one year.
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating normobaric hyperoxia NBO as a treatment for patients who have experienced an acute ischemic stroke and are transferred for endovascular thrombectomy EVT. The study aims to assess the effectiveness and safety of NBO in improving functional outcomes at 3 months after stroke. Stroke is a leading cause of death and disability, and although reperfusion treatments like thrombectomy improve blood flow, less than half of patients achieve favorable recovery. NBO is thought to protect the brain by rescuing hypoxic tissue and reducing damage processes, with advantages such as low cost and easy use. Participants will be randomly assigned to receive either NBO, which involves inhaling 100% oxygen alongside the best medical care, or best medical care alone. The study compares these two groups to see if NBO provides additional benefits. The treatment is given during the acute phase before or during transfer for EVT. The study includes a single-blind design and follows patients for outcomes over time. During the study, participants will have their disability level measured using the modified Rankin Scale at 90 days and one year after randomization. Other assessments include neurological function scores, imaging scans, infarct volume changes, and quality of life questionnaires at various time points. Safety and recovery progress are closely monitored throughout, with follow-up visits to track long-term effects. The total participation duration includes initial treatment and follow-up through one year.
Actively Recruiting
Researchers are evaluating the use of drug-coated balloon DCB treatment compared to guideline-directed medical therapy GDMT in patients with acute coronary syndrome who have non-flow limited vulnerable plaques. The goal is to determine if DCB treatment is better at improving cardiovascular outcomes. This is a multicenter, prospective, open-label, controlled, randomized clinical trial sponsored by Harbin Medical University. Participants with vulnerable plaques that do not limit blood flow will be randomly assigned to either receive DCB treatment along with guideline-directed medical therapy or to receive guideline-directed medical therapy alone without intervention on the vulnerable plaques. The DCB treatment involves pretreatment of non-culprit lesions, with the possibility of using a bail-out stent if needed. Both groups will follow guideline-directed therapy throughout the study. During the study, participants will be monitored for clinical outcomes such as target lesion failure and major cardiac adverse events at multiple time points up to 24 months. Researchers will assess heart function and plaque characteristics at baseline and follow-up, including imaging and biomarker tests. The study is designed to follow participants for at least two years to evaluate the safety and effects of the treatments on heart health and plaque stability.
Actively Recruiting
Researchers are investigating treatments for HER2-positive advanced breast cancer in patients who have already received at least two prior anti-HER2 therapies. This Phase III clinical trial compares the effects and safety of TQB2930, a HER2 bispecific antibody drug, combined with chemotherapy, against trastuzumab combined with chemotherapy. The study aims to evaluate which treatment approach may better manage advanced breast cancer that has progressed despite prior therapies. Participants are randomly assigned to one of two groups. One group receives TQB2930 injection at 30 mgkg every three weeks along with a chemotherapy agent chosen by the investigator, with each treatment cycle lasting 21 days. The other group receives trastuzumab starting with an 8 mgkg dose followed by 6 mgkg every three weeks, combined with investigator-selected chemotherapy, also given in 21-day cycles. Chemotherapy options include drugs like Capecitabine, Gemcitabine, Vinorelbine, or Eribulin. Throughout the study, participants undergo regular assessments to monitor disease progression and treatment response, including scans and evaluations lasting about one to two years. The main outcome measured is progression-free survival as assessed by an independent review committee. Additional outcomes include overall survival, duration of response, tumor response rates, and safety monitoring for adverse events. Blood samples are collected at specific cycles to measure drug levels and immune responses. The study includes safety follow-up for 90 days after the last dose or until another anticancer treatment begins.