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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
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This is designed a pragmatic study relevant to a broad range of patients with heart failure in sinus rhythm and is suitable for both primary and secondary care sites. Whole blood is sent to a central laboratory for the measurement of plasma concentrations of natriuretic peptides (NT-proBNP or MR-proANP)
The objective of this study is to determine whether treating patients with heart failure with clopidogrel 75mg/day is superior to treating them with aspirin 75mg/day. The main focus is on all-cause mortality but data on morbidity, symptoms, quality of life and on cardiovascular and renal function and anaemia will also be collected. A health economic analysis will be conducted if appropriate. Clearly, if no difference in outcomes is observed there is no value in a detailed health economic assessment.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Not Specified;
You can take part if:
You may not be able to take part if:
# Severe valve disease in the investigators opinion (an echocardiogram report within the previous 12 months must be available) # Plasma NTproBNP <400pg/ml (47.3pmol/L) or MRproANP <100pmol/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 anticoagulants. # Serum creatinine >250umol/L (local lab) a measure of the health status of the kidneys. # Intolerant of aspirin or clopidogrel or who have a contraindication to such treatment or who require anticoagulation 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 nonsteroidal antiinflammatory agents > 3 times a week o Use of maintenance oral corticosteroids o Women of childbearing potential or who are breast feeding o Patients with a history of asthma should not take part unless they have taken aspirin previously without illeffect. # Patients with an indication for oral anticoagulation 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 antiplatelet 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 childbearing age should be taking reliable contraception (tubal ligation or implanted contraceptive) # Inability to communicate in English. NonEnglish 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by HULL UNIVERSITY TEACHING HOSPITALS NHS TRUST and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) .
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Read full details
for Trial ID: CPMS 11191
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