View clinical trials related to Acute Coronary Syndrome.
Filter by:Background: Vascular closure devices (VCD) were developed to reduce access site bleedings, to improve patients´ comfort, and to accelerate ambulation after percutaneous coronary interventions (PCI). Despite higher complications rates in earlier studies, current data suggest similar complication rates or better outcomes after the use of VCD as compared to manual compression. ExoSeal (Cordis, Warren, NJ, USA) is a new, extravascular polyglycol acid (PGA) plug which occludes the puncture channel. Whether the use of this extravascular closure device is as effective as the more widely used plug/anchor mediated devices, has not been evaluated so far. We performed a randomized, multicentre, single-blinded trial to compare the efficacy of the extravascular closure device ExoSeal in comparison to the collagen-based plug/anchor mediated AngioSeal system. Methods: 304 patients receiving diagnostic angiography and/or PCI will be included in three centers. Exclusion criteria are contraindications for any VCD including 1. severe calcification of the access vessel, 2. severe peripheral artery disease, 3. puncture in the origin of the profound femoral artery, 3. non-femoral sheath insertion, 4. marked tortuosity of the femoral or iliac artery, 5. marked obesity or cachexia (BMI >40 or <20) and 6. patients on continuous medication with oral anticoagulants. After the procedure, angiography of the accessed femoral artery is performed to rule out major risk factors for retroperitoneal hemorrhage, relevant peripheral stenoses of the common or the superficial femoral artery, or a location of the puncture site in the bifurcation of the profundal femoral artery. We hypothesise, that the use of an extravascular closure device is not inferior to an anchor/plug mediated device regarding the occurrence of the following complications: bleeding, need for vascular surgery and device failure (primary endpoints). Secondary endpoints are the occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm within 24 hours after insertion of the device. Power was 80%, alpha 0.05. Bleeding will be defined according to the TIMI criteria. The study is actively enrolling patients, last inclusion will take place in September 2012. Results and Conclusions: Outcome data including the primary endpoint (bleeding, need for vascular surgery and device failure) will be presented for the first time.
Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In addition, behavioral treatment of emotional distress is known to decrease symptoms, and treatment usage. The present protocol tests whether the addition of a medication known to reduce emotional distress can also reduce symptoms and treatment usage. This will done by recruiting patients with ACS during their hospital stay, randomizing them to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6 months.
Our research will examine a chest pain care strategy, called the HEART pathway, which is designed to correctly identify Emergency Department patients at high-risk for cardiovascular events, likely to benefit from further testing, and patients at very-low-risk for cardiovascular events, who may be safely discharged home. By using an individual's risk assessment to determining testing, we hope to improve the quality and efficiency of the care delivered to Emergency Department patients with chest pain. Our study will determine if the HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, will reduce stress testing and cardiovascular imaging, decrease hospital length of stay, and reduce cost compared to usual care, while maintaining safety.
The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.
Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia. Secondary Objectives: - To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality). - To evaluate the safety and tolerability of alirocumab. - To evaluate the effect of alirocumab on lipid parameters.
This is a single-center, open-label prospective randomized pharmacodynamic investigation of two anti platelet regimens in patients who are planned to undergo PCI for non-ST segment elevation acute coronary syndrome(NSTE-ACS) for 24 hours 1. Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid) 2. Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min - both agents will be given on top of aspirin
The 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.
Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular closure device would decrease the prevalence of vascular complications at puncture site, reaching the non-inferiority criterion when compared to the radial access.
The purpose of this study is to explore the effect of 20mg high loading dose of rosuvastatin on recurrent events in patients with established DM who is admitted for an ACS.
This study is the first study of losmapimod in Japanese subjects. This study will be a single-center, single blind, phase I and two part study to characterize the safety, tolerability, pharmacokinetic and pharmacodynamic profiles in healthy Japanese volunteers (male and female of non-childbearing potential). Part1 will be a single dose, randomized, three-period, placebo-controlled and dose escalation part. Each subject will participate in 3 dosing sessions, and receive, on separate days, three of four treatments of losmapimod 2.5, 7.5 and 20 mg, and the matching placebo in the fasted state after overnight fast (at least 10 hours). The design incorporates sufficient washout between treatments (at least 7 days after the previous administration), and is an efficient design for the study objectives. Part 2 will be a fixed dose and placebo-controlled part. Each subject will participate in one dosing session, and receive losmapimod 7.5 mg or the matching placebo twice daily in the fasted state for 14 days. Only subjects will be blind to the sequence and dose studied. The study will include the placebo treatment to allow a valid evaluation of adverse events attributable to treatment versus those independent of treatment. Approximately 18 subjects in each part will receive treatments of losmapimod and/or placebo in the design. The primary objective of the study is to characterize the safety and tolerability of single doses and repeat doses of losmapimod in healthy Japanese subjects. Serial pharmacokinetic samples will be collected and safety assessments will be performed following each dose.