Heart Failure and Coronary Artery Disease Circulatory System Heart Failure and Coronary Artery Disease
Conditions
Interventions
Epleronone or placebo
Sponsors
East and North Hertfordshire NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years 2. Stable documented CAD or stable HF (functional state New York Heart Association Class II or III) and healthy volunteers
Exclusion criteria
Exclusion criteria: 1. Inability to consent 2. Current participation in another study 3. Over 80 years and under 18 years 4. Acute coronary syndrome within four weeks 5. Acute hospital admission with HF in preceding four weeks 6. Stroke in the last four weeks 7. Insulin-dependent diabetes mellitus 8. Renal impairment 9. Sepsis 10. Malignancy 11. Bleeding diathesis 12. Concomitant medication with clopidogrel, erythromycin, dipyridamole, warfarin, glycoprotein 2b/3a inhibitors, epleronone, spironolactone or angiotensin II antagonists 13. When complete follow up over one week period in the judgment of the investigator is unlikely 14. Any disease shortening life-expectancy to less than 12 months 15. Blood dyscrasia 16. Intolerance to or contra-indication to aspirin 17. Any contra-indication to Epleronone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end-point within each group will be the change in platelet reactivity and thrombolytic status from baseline, following treatment with epleronone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed