Clopidogrel versus Aspirin in Chronic HEart failure

Phase 4

• Conditions: Heart failure; Circulatory System

• Registration Number: ISRCTN13415258
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)

Brief Summary

2014 results in: https://academic.oup.com/eurheartj/article/35/suppl_1/1/541954 [added 18/04/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-08
• Study Completion: 2016-08-31
• Last Update Posted: 13 May 2019

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 87

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All causes mortality

Secondary Outcome Measures

Name	Time	Method
<br> 1. Cardiovascular death or hospitalisation for heart failure (time to first event)<br> 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<br> 3. Total days lost to death or hospitalisation (all causes)<br> 4. Quality-adjusted years alive (QALY) using repeated measurements of EQ5D<br> 5. Cost per QALY<br>