NCT00222638已完成4 期
Randomized Blinded Cross-Over Clinical Trial Investigate the Interactions Between Influenza Vaccination and Oral Anticoagulant Therapy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 1.Variations in INR value and in OAT weekly dosage after IV
研究概览
简要总结
The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination
详细描述
The pharmacokinetic and the pharmacodynamic interactions and the possible clinical events connected with the simultaneous administration of Oral Anticoagulants (OA) and the influenza virus vaccine were evaluated in several small studies which yielded conflicting results, thus encouraging additional investigations with prospective studies in order to obtain a more consistent evidence about the safety and efficacy of vaccination against influenza virus in patients on OA Treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OA Treatment
- •Stable anticoagulation (previous two controls in range)
- •Presence of indication for Influenza Vaccination
- •Life expectancy > 6 months
- •Signed Informed consent
排除标准
- •Absence of stable anticoagulation
- •Absence of indication for Influenza Vaccination
- •Life expectancy < 6 months
- •Denied Informed Consent
结局指标
主要结局
1.Variations in INR value and in OAT weekly dosage after IV
次要结局
- 1.Efficacy of IV in patients on OAT
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable WarfarinHypoprothrombinemiaNCT02267408McMaster University42
已完成
3 期
Clarification of Optimal Anticoagulation Through GeneticsStrokeAtrial FibrillationAtrial FlutterVenous ThrombosisNCT00839657National Heart, Lung, and Blood Institute (NHLBI)1,015
已完成
不适用
Assessment of International Normalized Ratio (INR) Prolongation in Patients Treated Simultaneously With Warfarin and CephalosporinsAtrial FibrillationPulmonary EmbolismVenous ThrombosisNCT01857050Meir Medical Center236
已完成
3 期
ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment ElevationHypertensionMyocardial IschemiaNCT00296218Sanofi440
已完成
2 期
The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary InterventionAngioplasty, Transluminal, Percutaneous CoronaryNCT00133731Sanofi947