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临床试验/NCT02838537
NCT02838537Unknown不适用

TRiptan Use and Serious Vascular Events in Elderly Over 65 Years

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 25,000 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
25,000
试验地点
1
主要终点
Occurence of the first vascular event leading to a hospitalization within the exposure period following the first dispensation of a triptan.

研究概览

简要总结

This study will be conducted as a retrospective study of exposed and unexposed cohort of the French population included all beneficiaries aged 65 and older. Exposed patients will be matched to non exposed controls according age, gender and area of residence (ratio 1/4). Two exposed arms and two non exposed control arms will be planned. Triptan arm will be user of triptan defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users"). Ergot arm will be user of ergot derivative defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users"). This study involved data from the French National Health Insurance Information System (Système National d"Information Inter-Régimes de l"Assurance Maladie ; SNIIRAM) linked with the French hospital discharge database (Programme de Médicalisation des Systèmes d"Informations, PMSI).

  • The SNIIRAM is a vast national medico-administrative database representing the most part of the French population, allowing to identify and to describe precisely all medication dispensations (name of drug, date of dispensing and quantity) including triptans and other reimbursed medications.
  • The PMSI provides medical information about all patients admitted to hospital in France, including discharge diagnoses encoded according ICD-10, medical procedures and French diagnosis-related groups The research proposed is expected to provide an update and nationally-consolidated estimation of the cardiovascular risk is associated to triptans use in elderly population.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 65 and more
  • Patients registered in the SNIIR-AM
  • To avoid depletion of susceptibles bias, only incident users will be included. Incident users are defined by the lack of reimbursement for triptan (or ergot derivatives) prior six months of the study period.

排除标准

  • no exclusion criteria

研究组 & 干预措施

Triptan Arm

Users of triptan defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users")

干预措施: Exposure to Triptan (Drug)

Ergot Arm

Users of ergot derivative defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users")

干预措施: Exposure to Ergot (Drug)

结局指标

主要结局

Occurence of the first vascular event leading to a hospitalization within the exposure period following the first dispensation of a triptan.

时间窗: Up to 4 years

次要结局

  • Assessment of the mortality with an underlying cardiovascular cause occuring in hospital(Up to 4 years)
  • Assessment of the mortality: number of all deaths(Up to 4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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