ISRCTN13415258终止4 期
A randomised, open-label, study comparing the effects of aspirin and clopidogrel on outcomes in patients with chronic heart failure
Hull and East Yorkshire Hospitals NHS Trust (UK)0 个研究点目标入组 87 人开始时间: 2012年2月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 87
研究概览
简要总结
2014 results in: https://academic.oup.com/eurheartj/article/35/suppl_1/1/541954 [added 18/04/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Willing and able to provide written confirmation of informed consent
- •2. A clinical diagnosis of heart failure
- •3. Currently in sinus rhythm on clinical examination
- •4. Receiving diuretics for at least 6 weeks prior to inclusion
- •5. Patients must have a telephone
- •6. Patients must be willing to provide their personal contact details, those of their next of kin and those of their general practitioner (GP) and hospital to the national coordinating office and be willing to be contacted by telephone by these staff.
- •7. Patients must be willing to have hospitalisation and other serious events tracked through mechanisms including:
- •7.1. In England:
- •7.1.1. The National Health Service (NHS) Central Register (NHSCR)
- •7.1.2. National Office of Statistics
- •7.2. In Scotland:
- •7.2.1. The Registrar General?s Office
- •7.2.2. NHS Information Statistics Division
- •8. If non-English speaking, patients must have a friend or relative who can translate or who have other access to translation
排除标准
- •1. Plasma (central lab) NT-proBNP <400pg/ml (47.3pmol/L) or MR-proANP <200pmol/L
- •2. 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.
- •3. Severe valve disease in the investigators opinion (an echocardiogram report within the previous 12 months must be available)
- •4. Serum creatinine >250umol/L (local lab)
- •5. Intolerant of aspirin or clopidogrel or who have a contraindication to such treatment or who require anti-coagulation
- •6. Contraindications to aspirin or clopidogrel include:
- •6.1. Substantial, in the investigators opinion, bleeding from an uncorrected source within the previous year
- •6.2. Endoscopically proven peptic ulcer within the previous 3 months. Patients must be on treatment if peptic ulcer diagnosed in previous year
- •6.3. Haemorrhagic stroke within the previous 3 months
- •6.4. Known coagulation disorder (e.g. haemophilia)
- •6.5. Full blood count suggesting iron deficiency (patients may be enrolled in the study after the cause of iron deficiency is or has previously been investigated and treatment has been initiated) (local lab)
- •7. Platelet count <100,000 (local lab)
- •8. Scheduled procedure that would require discontinuation of study medication for > 2 weeks (patient may be recruited after procedure)
- •9. History of uncontrolled seizures or high risks of falls
- •10. Regular use of non-steroidal anti-inflammatory agents > 3 times a week
- •11. Use of maintenance oral corticosteroids
- •12. Women of child-bearing potential or who are breast feeding
- •13. Patients with a history of asthma should not take part unless they have taken aspirin previously without ill-effect
- •14. Patients with an indication for oral anti-coagulation including:
- •14.1 Current or recent (within 12 months) atrial fibrillation or flutter (evidence of an ECG documenting sinus rhythm must be provided)
- •14.2. Prior embolic stroke
- •14.3. Mechanical prosthetic heart valve
- •15. Patients requiring dual anti-platelet therapy including:
- •15.1. Patients within 3 months of an acute coronary syndrome
- •15.2. Transient ischaemic attack or vascular procedure or within one year of receiving a drug eluting coronary stent
- •16. Patients likely to die of something other than heart failure or sudden (cardiac) death
- •17. Inability to walk without the physical assistance of another person (patients with walking aids are permitted)
- •18. Other patients deemed unlikely to comply with the protocol
- •19. Women who are at pregnant or who could become pregnant
- •20. Women of child-bearing age should be taking reliable contraception (tubal ligation or implanted contraceptive)
- •21. Inability to communicate in English
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