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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 18Years +All GendersPhase 3
1365 locations
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Actively Recruiting

Researchers are evaluating the effectiveness and safety of the Ultimaster Tansei stent andor Ultimaster Nagomi stent in patients with coronary artery disease during routine clinical practice. This prospective observational study aims to collect real-world data on these stents to better understand their performance and safety profile in everyday medical settings. Participants receive the Ultimaster Tansei stent andor Ultimaster Nagomi stent as part of their usual care for coronary artery stenosis. There are no experimental treatments or placebo groups in this study, as it observes patients who have already received these devices. The study follows patients over time to monitor outcomes related to the stent use. During the study, participants will have clinical follow-ups according to routine care schedules. Researchers will collect data on key outcomes such as the composite event rate of death, nonfatal heart attacks, or ischemic-driven target-vessel revascularization within one year. Secondary outcomes include rates of death, cardiac events, revascularization procedures, stent thrombosis, stroke, procedural success, and bleeding complications monitored up to five years. This long-term observation helps to assess the real-world safety and effectiveness of these stents.

Age: 19Years +All Genders
11 locations
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Actively Recruiting

This research aims to evaluate the effectiveness and safety of the DESyne X2, a novolimus-eluting coronary stent, in routine clinical practice. The study focuses on patients with coronary stenosis, coronary occlusion, or coronary disease and observes their outcomes over time. It is a multicenter, prospective observational study designed to gather real-world data on this device. Participants are those who have undergone intervention with the DESyne X2 stent. The study does not involve randomization or treatment assignment but follows patients who received this particular stent as part of their care. The main outcome measured is the composite event rate within one year, with secondary outcomes including various cardiac events and procedural success tracked up to five years. During the study, participants will be monitored over several years for outcomes such as death, myocardial infarction, revascularization procedures, stent thrombosis, and stroke. Data will be collected according to routine clinical visits, and safety outcomes are observed without altering standard medical care. The total participation duration extends up to the study completion date in 2031, with primary outcome assessment at one year and longer-term follow-up continuing for several years.

Age: 19Years +All Genders
6 locations
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Actively Recruiting

Researchers are comparing the effects of optical coherence tomography OCT-guided versus angiography-guided percutaneous coronary intervention PCI in patients who have suffered an acute myocardial infarction AMI. The study aims to determine if using OCT imaging during PCI can improve clinical outcomes by better guiding stent placement and optimization compared to traditional angiography alone. This trial addresses limitations of angiography and builds on previous research that has not conclusively shown long-term benefits of OCT guidance in AMI treatment. Participants will be randomly assigned to one of two groups one receiving standard PCI guided by angiography and the other receiving PCI guided by OCT imaging. In the OCT group, OCT imaging is used before, during, and after stent placement to optimize treatment, with specific criteria for stent expansion, apposition, and edge dissection. The angiography group will have PCI performed using standard visual assessments and stent optimization based on angiographic findings. Both groups undergo PCI procedures aimed at reopening blocked coronary arteries causing the heart attack. During the study, participants will be monitored for up to two years following their PCI procedure to assess clinical outcomes such as target vessel failure and other cardiac events. Researchers will collect data on death rates, myocardial infarctions, revascularization needs, stent thrombosis, and procedural details like fluoroscopy time and contrast use. Safety measures including monitoring for kidney injury related to contrast dye will also be included. This long-term follow-up will help determine the impact of OCT-guided PCI compared to angiography-guided PCI in patients with AMI.

Age: 19Years +All GendersPhase Not Applicable
18 locations
S

Actively Recruiting

Researchers are investigating the best timing for coronary angiography CAG in patients who have non-ST-segment elevation myocardial infarction NSTEMI complicated by acute decompensated heart failure AHF. The study aims to compare immediate CAG performed within 2 hours of NSTEMI diagnosis versus delayed CAG after the patients symptoms have stabilized. This trial addresses the lack of randomized clinical data on optimal CAG timing in this high-risk group, despite current guidelines recommending early intervention. Participants will be randomly assigned to one of two groups one receiving coronary angiography within 2 hours after NSTEMI diagnosis, and the other undergoing angiography after stabilization of acute heart failure symptoms, such as improved breathing and reduced pulmonary congestion. The study is open-label and multicenter, focusing on evaluating both the efficacy and safety of immediate versus delayed CAG in these patients. During the study, researchers will monitor participants for outcomes including death from any cause, non-fatal heart attacks, and hospitalizations for heart failure over a 12-month period. Additional assessments include tracking cardiovascular events, bleeding, kidney injury, and in-hospital death rates at various time points up to 36 months. Participants clinical status will be followed closely throughout hospitalization and after discharge to evaluate the long-term effects of the timing of coronary angiography.

Age: 19Years +All GendersPhase Not Applicable
20 locations