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  • How old am I:
  • 36
  • Tone of my eyes:
  • Enormous brown
  • My Sign of the zodiac:
  • Sagittarius
  • I like to drink:
  • White wine
  • Hobbies:
  • I like roller-skating
  • Smoker:
  • No

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Study record managers: refer to the Data Element Definitions if submitting registration or information. Novel androgen axis drugs [NA] such as abiraterone or enzalutamide are allowed. The study is open-label and patients will be monitored Alabama folks online dating the 6 to month treatment period for survival, disease progression, and adverse events. A long-term follow-up period will include the collection of rPFS survival and information about new treatments, responses to new treatments, adverse events assessment, as well as blood for hematology and chemistry testing.

Description

Study record managers: refer to the Data Element Definitions if submitting registration or information. Drug: Placebo Administered subcutaneously using a spring-based prefilled 1. Experimental: Evolocumab Participants received evolocumab mg Q2W or mg QM subcutaneous injections according to their own preference. Biological: Evolocumab Administered subcutaneously using a spring-based prefilled 1.

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KM estimates at Irving TX woman dating internet, 12, 18, 24, 30 and 36 months are reported. Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier KM survival analysis.

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KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint vietnamese dating Canton OH date. Cardiovascular death includes death resulting from an acute myocardial infarction MIsudden cardiac death, death due to heart failure HFdeath due to stroke, death due to cardiovascular CV procedures, death due to CV hemorrhage, and death due to other CV causes.

Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death milf dating Clarksville was analyzed using Kaplan-Meier KM survival analysis. Participants with no event were censored based on the last confirmed survival status date. The diagnosis of myocardial infarction required the combination of:.

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Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. Stroke was defined as an acute episode of Massachusetts women us dating or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.

Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier KM survival analysis. Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier KM survival analysis.

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HF hospitalization was defined as an event that met all of the following criteria:. Documented new or worsening symptoms due to HF, including at least 1 of the following:.

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Ischemic stroke Detroit free chat online defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack TIA was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.

Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms. Save this study.

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Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details.

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First Posted : February 15, Last Update Posted : August 21, Study Description. The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

Drug Dating bath Corpus Christi TX available for: Evolocumab. FDA Resources.

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Arms and Interventions. Administered subcutaneously using a spring-based prefilled 1.

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Participants received evolocumab mg Q2W or mg QM subcutaneous free trial chat line Ontario CA according to their own preference. Outcome Measures.

Primary Outcome Measures : Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. Secondary Outcome Measures : Time to Cardiovascular Death, Myocardial Infarction, or Stroke [ Time Frame: Events that executive dating Chicago reviews from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months.

Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier KM survival analysis. Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier KM survival analysis.

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The diagnosis of myocardial infarction required the combination of: Evidence of myocardial necrosis either changes in cardiac biomarkers or post-mortem pathological findings ; and Supporting information derived from the clinical presentation, electrocardiographic changes, or the of myocardial or coronary artery Imaging. HF hospitalization was defined as an event that met all of the following criteria: Admitted to hospital black men dating Tacoma women a primary diagnosis of HF In hospital for at least 24 hours Documented new or worsening symptoms due to HF, including at least 1 of the following: Dyspnea Decreased exercise tolerance Fatigue Other symptoms of worsened end-organ Appleton WI dating women or volume overload Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion Received new or increased treatment for HF.

Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Eligibility Criteria. Contacts and Locations.

Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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Please refer to this study by its ClinicalTrials. More Information.

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Additional Information: AmgenTrials clinical trials website. N Engl J Med. Epub Mar JAMA Cardiol.

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J Am Coll Cardiol. Epub Nov PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular asian online dating Chandler. Cochrane Database Syst Rev. Epub Apr Erratum in: J Am Coll Cardiol. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial. Lancet Diabetes Endocrinol. Epub Sep Epub Aug High cholesterol Treatment Tallahassee FL dating rules high cholesterol Lowering cholesterol Lowering high cholesterol Hypercholesterolemia.

National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Biological: Evolocumab Drug: Placebo. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :.

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Actual Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Placebo Comparator: Placebo Participants received Dallas Texas TX area speed dating subcutaneous injections either once every 2 weeks Q2W or once a month QM according to their own preference.

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