NCT01998399终止2 期
Randomized Trial of Ticagrelor for Severe Community Acquired Pneumonia
Gordon Bernard26 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 26
- 主要终点
- All-cause Mortality
研究概览
简要总结
The purpose of this study is to determine if the drug ticagrelor will be an effective treatment for patients with severe community acquired pneumonia. The primary objective is to reduce all-cause mortality in the ticagrelor group compared to the placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will have new "severe" CAP as defined by
- •a. New (within 72 hours of hospital admission) radiographic finding consistent with pneumonia and admission or planned admission to an ICU for: i. Mechanical Ventilation (invasive or non-invasive) OR ii. Vasopressors (dobutamine and phosphodiesterase are not considered vasopressors for this criteria) OR iii. ICU admission due to severe respiratory distress or arterial desaturation. b. At least two of the following; i. recent increase in dyspnea ii. increased sputum production iii. change of character of sputum iv. White Blood Cells > 12,000 or < 4,000 cells/mm3 or >10% bands v. Body temperature >38ºC or <36ºC (any route)
排除标准
- •More than 72 hours have passed since meeting required inclusion criteria.
- •Development of pneumonia after 72 hours of current hospitalization.
- •Underlying disease likely to cause mortality within 90 days of randomization.
- •A resident in a hospital, not nursing home, within 30 days prior to development of pneumonia.
- •Patients who are moribund (not expected to live for more than 48 hours).
- •No consent/inability to obtain consent from patient or surrogate.
- •Patient's physician is unwilling to have patient enter the study.
- •Age less than 50 years.
- •Breast feeding.
- •Underlying immunodeficiency (e.g. HIV, neutropenia, active hematologic malignancy, functional or anatomical asplenia and hypogammaglobulinemia).
- •Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she will receive all supportive care except for attempts at resuscitation from cardiac arrest).
- •Unable to receive or unlikely to absorb enteral study drug (e.g., patients with partial or complete mechanical bowel obstruction, intestinal ischemia, infarction, and short bowel syndrome).
- •Hepatic impairment
- •a. Child Pugh score > 7 using data from outpatient setting
- •Conditions that increase the risk of bleeding, e.g.:
- •Surgery or the likely need for surgery during study, or evidence of active bleeding postoperatively (ICU procedures such as line placement, tracheostomy and chest tubes are not to be considered for this exclusion);
- •A history of severe head trauma requiring hospitalization or intra-cranial surgery within 3 months;
- •Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or mass lesions of the central nervous system, hemorrhagic stroke or intracranial hemorrhage, or congenital bleeding diathesis;
- •Gastrointestinal bleeding within 6 weeks before the study unless a corrective procedure has been performed;
- •Recent trauma considered to increase the risk of bleeding.
- •Chronic renal disease requiring renal replacement therapy.
- •Creatinine > 3 mg/dL.
- •Platelet count < 50,000 /mm
- •Use of a P2Y12 inhibitor within the 3 months prior to randomization or physician intent to initiate one of the CYP3A inhibitors, e.g. ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, atazanovir, saquinavir, nelfinavir, indinavir, or telithromycin.
- •Use of CYP3A inducers, e.g. rifampin, phenytoin, carbamazepine and phenobarbital.
- •Simvastatin or Lovastatin doses > 40 mg per day.
- •Digoxin use.
- •Receiving aspirin and physician and/or patient unwilling to reduce aspirin dose to <100 mg per day.
- •Daily Non-steroidal anti-inflammatory drugs (NSAID) use as an outpatient (other than Aspirin (ASA) as above).
- •Sick Sinus Syndrome, 2nd or 3rd degree heart block, bradycardia induced syncope - unless pacemaker in place.
- •Otherwise unsuitable for participation in the opinion of the investigator (i.e., homeless, non-compliant, etc.).
研究组 & 干预措施
Ticagrelor
Experimental
Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
干预措施: Ticagrelor (Drug)
Placebo
Placebo Comparator
Placebo 180 mg loading dose followed by 90 mg BID for 90 days.
干预措施: Placebo (Drug)
结局指标
主要结局
All-cause Mortality
时间窗: 90 days
death during 90 day study period
次要结局
- Myocardial Infarction(90 days)
- Hospital Free Days(29 days)
- Stroke(90 days)
- In-hospital Mortality(Throughout hospitalization (About 2 weeks))
- Shock Free Days(15 days)
- Ventilator Free Days(29 days)
- Stroke, Myocardial Infarct, Mortality(90 days)
研究者
Gordon Bernard
Professor of Medicine
Vanderbilt University Medical Center
研究点 (26)
Loading locations...
相似试验
已完成
4 期
Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary SyndromeAcute Coronary Syndrome (ACS)NCT01944800Deutsches Herzzentrum Muenchen4,018
已完成
3 期
A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT01991795AstraZeneca19,271
已完成
3 期
[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]Acute Ischaemic StrokeTransient Ischaemic AttackNCT01994720AstraZeneca13,307
已完成
2 期
A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell DiseaseSickle Cell DiseaseNCT02482298AstraZeneca87
已完成
不适用
Evaluation on the Safety of Ticagrelor Among Chinese ACS PatientsAcute Coronary Syndrome (ACS)NCT02430493AstraZeneca1,066