|
Welcome
|
|
17 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Clopidogrel versus Aspirin in Chronic HEart failure |
| ISRCTN | ISRCTN13415258 |
| ClinicalTrials.gov identifier | |
| Public title | Clopidogrel versus Aspirin in Chronic HEart failure |
| Scientific title | A randomised, open-label, study comparing the effects of aspirin and clopidogrel on outcomes in patients with chronic heart failure |
| Acronym | CACHE |
| Serial number at source | 2009-011637-27 |
| Study hypothesis |
Compared to clopidogrel, aspirin has an adverse effect on cardiovascular function in patients with heart failure leading to an increase in the symptoms of heart failure, reduced quality of life, an increase in hospitalisation and a higher mortality.
Demonstrating whether such differences do or do not exist would be valuable and settle a substantial controversy in care, highlighted in international guidelines for the management of heart failure. The protocol designed to address this in an non-blinded, randomised controlled trial comparing aspirin and clopidogrel, conducted in 3,000 patients with heart failure over a period of approximately 5 years. |
| Lay summary | http://www.hta.ac.uk/2144 |
| Ethics approval | Northern & Yorkshire REC, 15 May 2012 ref: 10/H0903/13 |
| Study design | Phase IV trial open label interventional non blinded randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cardiovascular |
| Participants - inclusion criteria |
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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 11/02/2011 |
| Anticipated end date | 31/08/2016 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 3000 |
| Interventions |
Clopidogrel vs Asprin both 75mg/day per patient taken orally & daily.
This phase IV trial will compare the effects of prescribing aspirin 75mg/day and clopidogrel 75mg/day, primarily on all-cause mortality. Half of the patients will be randomised to each intervention. The investigator and the patient will know to which treatment the patient has been assigned. The duration of the study is determined by the event-rate although it could be stopped early for futility or because of a larger than anticipated treatment difference. The planned mean duration of follow-up is 3.8 years and some patients may be followed for more than five years before the required number of events has been attained. However, to allow for uncertainty we seek permission to follow patients for up to ten years. |
| Primary outcome measure(s) | All causes mortality |
| Secondary outcome measure(s) |
1. Cardiovascular death or hospitalisation for heart failure (time to first event)
2. Sudden death or a vascular event (myocardial infarction, stroke, peripheral embolism, requirement for angioplasty or vascular surgery) using a time to first event analysis 3. Total days lost to death or hospitalisation (all causes) 4. Quality-adjusted years alive (QALY) using repeated measurements of EQ5D 5. Cost per QALY |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) ref: 08/53/36 |
| Trial website | |
| Publications | |
| Contact name | Prof John Cleland |
| Address |
Department of Cardiology
Daisy Building Castle Hill Hospital Castle Road Cottingham |
| City/town | Hull |
| Zip/Postcode | HU16 5JQ |
| Country | United Kingdom |
| Tel | +44 (0)1482 761776 |
| Fax | +44 (0)1482 761779 |
| j.g.cleland@hull.ac.uk | |
| Sponsor | Hull and East Yorkshire Hospitals NHS Trust (UK) |
| Address |
Research and Development Department
Daisy Building Castle Hill Hospital Castle Road |
| City/town | Hull |
| Zip/Postcode | HU16 5JQ |
| Country | United Kingdom |
| Tel | +44 (0)1482 461882 |
| Fax | +44 (0)1482 461886 |
| priyai.parkinson@hey.nhs.uk | |
| Sponsor website: | http://www.hey.nhs.uk/ |
| Date applied | 11/01/2012 |
| Last edited | 08/02/2012 |
| Date ISRCTN assigned | 08/02/2012 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|