A Clinical Trial to Evaluate the Effect of Food on PK and PD of Vicagrel Capsules in Healthy Adult...
Acute Coronary SyndromeThis clinical study will adopt a randomized, open-label, single-dose, 3-cycle, 3-way crossover design to explore the PK and PD profiles of a single oral dose of vicagrel capsules under fasted and fed conditions in health subjects.
Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients
Acute Coronary SyndromesST Elevation Myocardial InfarctionTo examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.
Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS...
Acute Coronary SyndromeA placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.
Vascular Healing After Deployment of Titanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™...
Acute Coronary SyndromeThe purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent stent and Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention. Comparison of OCT and CFR findings of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent and Promus-Element™ everolimus-eluting stent at two months after the index procedure. Comparison of intravascular coronary flow reserve measurement to non-invasive transthoracic echocardiography-derived coronary flow reserve measurement. Comparison of epicardial vasodilation to coronary microcirculatory vasodilation
Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects
Acute Coronary SyndromeThe objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.
Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome
Acute Coronary SyndromeThe aim of the study is to investigate the quality of prehospital emergency care in acute coronary syndromes, when paramedics are supported telemedically by an EMS physician.
Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated...
Acute Coronary SyndromeThis purpose of this study is to measure platelet response to ticagrelor and eptifibatide bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion administrated after cardiac catheterization in patients undergoing non-emergent percutaneous coronary intervention.
A Pharmacodynamic Study of a Personalized Strategy for P2Y12 Inhibition Versus Ticagrelor in Reducing...
Acute Coronary SyndromePercutaneous Coronary InterventionIn patients with heart attacks, the treatment of choice is to restore blood flow with percutaneous coronary intervention (PCI) (use of stents (metal meshes) to open blockages). After PCI, the standard drug treatment includes aspirin and clopidogrel. These medications block full function of the platelet cells, which are responsible for clotting. Despite their use, patients after PCI are at risk for heart attacks, sudden clotting of stents or death. A major contributor may be resistance to clopidogrel. New more potent drugs, which can overcome the resistance, are now available; however, they come with an increase chance of severe bleeding and costs. An ideal solution would be to identify at-risk patients and selectively treat them with more potent drugs, while lower-risk patients continue with clopidogrel. This type of strategy (personalized strategy) would decrease heart attacks and death (compared to clopidogrel), while also preventing bleeding complications (compared to treating all patients with the new drugs). Of resistant patients, many carry genes (inherited units) that prevent proper absorption of clopidogrel. Our group has developed and tested a new bedside genetic test, which identifies carriers of at-risk genes. However, this technique alone does not identify all at-risk patients. Consequently, we have now devised a novel tool, which combines genetics with patient characteristics to identify high-risk patients. The present study combines this new tool into a strategy for personalized treatment. Patients with heart attacks who undergo PCI will be randomly assigned to 1 of 3 strategies: a) new personalized strategy, b) clopidogrel strategy (previous standard drug) or c) ticagrelor strategy (stronger approved drug). The function of the platelet cells will be measured at 1 month to determine potential benefits. Evaluation of this new personalized strategy is important for improving patient outcomes after PCI. The hypothesis is that patients receiving a personalized strategy will have decrease risk for future heart attacks and bleeding.
Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes
Acute Coronary SyndromesFor octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.
A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events...
Acute Coronary SyndromeLosmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.