EUCTR2009-011637-27-GB进行中（未招募）1 期
Clopidogrel versus Aspirin in Chronic Heart Failure - CACHE
Hull and East Yorkshire NHS Hospital Trust0 个研究点目标入组 0 人开始时间: 2010年7月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •# 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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •# 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)
- •o Full blood count suggesting iron deficiency (patients may be enrolled in the study after the cause of iron deficiency is investigated and treated) (local lab)
- •o Platelet count <100,000 (local lab) - a measure of the body's ability to clot blood
- •o Scheduled procedure that would require discontinuation of study medication for > 2 weeks (patient may be recruited after procedure)
- •o History of uncontrolled seizures or high risks of falls,
- •o Use of non-steroidal anti-inflammatory agents > 3 times a week
- •o Use of maintenance oral corticosteroids
- •o Women of child-bearing potential or who are breast feeding
- •o Patients with a history of asthma should not take part unless they have taken aspirin previously without ill-effect.
- •# Patients with an indication for oral anti-coagulation including
- •? current or recent (within 12 months) atrial fibrillation or flutter (evidence of an ECG documenting sinus rhythm must be provided)
- •? prior embolic stroke
- •? mechanical prosthetic heart valve
- •# Patients requiring dual anti-platelet therapy are also excluded including patients within 3 months of an acute coronary syndrome, transient ischaemic attack or vascular procedure or within one year of receiving a drug eluting coronary stent.
- •# Patients likely to die of something other than heart failure or sudden (cardiac) death are excluded
- •# Inability to walk without the physical assistance of another person (patients with walking aids are permitted)
- •# Other patients deemed unlikely to comply with the protocol.
- •# Women who are at pregnant or who could become pregnant. Women of child-bearing age should be taking reliable contraception (tubal ligation or implanted contraceptive)
- •# Inability to communicate in English. Non-English speaking patients who have a friend or relative who can translate or who have other access to translation may participate.
- •# Patients who are unable to provide written informed consent
研究者
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