Anglo-Scandinavian Cardiac Outcomes Trial: Post Trial Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,718
- 试验地点
- 1
- 主要终点
- Number of Participants Who Have Died From Cardiovascular Disease Since the End of the ASCOT Study
研究概览
简要总结
ASCOT-10 is a follow-up study of surviving participants in the United Kingdom (UK)arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) which was conducted between 2000 and 2005.ASCOT's results showed substantial cardiovascular benefit from: 1) the use of a cholesterol lowering drug (atorvastatin) compared to placebo, and 2) the use of a blood-pressure lowering strategy based on amlodipine when compared to a strategy based on atenolol. ASCOT-10 will test the hypothesis that the ASCOT subjects who originally received Atorvastatin and those who received amlodipine based treatment will continue to show a cardiovascular benefit relative to those who did not, even though all the subjects have had access to optimal treatment in the interim.
详细描述
Study investigators will have access to information about ASCOT patients from their study centre who have died since the end of the ASCOT study in 2005. Of the 8580 ASCOT patients from the United Kingdom, 7300 were flagged with The Information Centre for Health and Social Care at the end of the trial in 2005.This flagging process was re-activated in 2010 so that all deaths and incident cancers relating to these patients are now sent every three months to the ASCOT-10 co-ordinating centre. These results are identified by the ASCOT study number, with all personal data removed. These deceased patient numbers will be communicated to the participating sites so that the trial centre staff will not contact their families.
An attempt will be made to contact all remaining patients from the participating UK ASCOT sites.
Initial contact will be made via the general practitioner (GP) surgery. If the GP can provide up-to-date contact details and feels that it is appropriate to contact the patient, patients will then be sent an introductory letter, a patient information sheet, a consent form and a health questionnaire.
They will be asked to complete a 'tick-box' form given the following options:
- Willing to complete health questionnaire.
- Willing for information about health to be given by GP or next of kin.
- Willing to give information by telephone only.
- Willing to attend study clinic for a single visit.
- Not willing to take part.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surviving ASCOT participants from the participating UK sites
排除标准
- 未提供
结局指标
主要结局
Number of Participants Who Have Died From Cardiovascular Disease Since the End of the ASCOT Study
时间窗: 16 years
Number of participants who have died from cardiovascular disease since the end of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Armstudy
Number of Participants With Non Fatal Myocardial Infarction
时间窗: 16 years
Morbidity of non fatal myocardial infarction after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial with two groups
Number of Participants With Non Fatal Stroke/TIA (Transient Ischaemic Attack)
时间窗: 16 years
Non fatal stroke and TIA (Transient Ischaemic Attack) morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial
次要结局
- Number of Participants Who Have Developed Diabetes Since the End of the ASCOT Trial(16 years)
- Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial(16 years)
- Number of Participants Who Have Experienced a Transient Ischaemic Attack (TIA) Since the End of the ASCOT Trial(16 years)
- Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial(16 years)