Clopidogrel versus Aspirin in Chronic Heart Failure - CACHE

Hull and East Yorkshire NHS Hospital Trust0 个研究点目标入组 0 人2010年7月29日

概览

暂无简介。

注册库

who.int

开始日期

2010年7月29日

结束日期

2013年4月10日

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Hull and East Yorkshire NHS Hospital Trust

•\# Willing and able to provide written confirmation of informed consent
•\# A clinical diagnosis of heart failure
•\# Currently in sinus rhythm on clinical examination (supported by ECG evidence in previous year)
•\# Receiving diuretics for at least 6 weeks prior to inclusion
•\# Patients must have a telephone
•\# Patients must be willing to provide their personal contact details, their next of kin and those of their GP and hospital and local pharmacies to the national coordinating office and be willing to be contacted by telephone by these staff and be willing for the monitoring staff to contact their GP, hospital and pharmacies.
•\# Patients must be willing to have hospitalisation and other serious events tracked through mechanisms including, in England, the NHS Central Register (NHSCR) and the National Office of Statistics and, in Scotland, The Registrar General’s Office and NHS Information Statistics Division
•Patients will be included regardless of aetiology (medical origins) of disease, since the great majority of patients with heart failure either have ischaemic heart disease as the primary cause or as a co\-morbid condition.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•\# Severe valve disease in the investigators opinion (an echocardiogram report within the previous 12 months must be available)
•\# Plasma NT\-proBNP \<400pg/ml (47\.3pmol/L) or MR\-proANP \<200pmol/L (central lab)
•\# Lack of an ECG within the previous 12 months documenting sinus rhythm. Patients who have had an episode of atrial fibrillation in the previous year may be enrolled provided the most recent ECG shows sinus rhythm and the treating doctor has decided not to prescribe anti\-coagulants.
•\# Serum creatinine \>250umol/L (local lab) \- a measure of the health status of the kidneys.
•\# Intolerant of aspirin or clopidogrel or who have a contra\-indication to such treatment or who require anti\-coagulation will be excluded.
•\# Contraindications to aspirin or clopidogrel include
•o Substantial, in the investigators opinion, bleeding from an uncorrected source within the previous year,
•o Recent peptic ulcer disease
•o History of haemorrhagic stroke,
•o Known coagulation disorder (eg:\- haemophilia)