Effect of epleronone on thrombotic and thrombolytic status in heart failure and coronary artery disease

Completed

• Conditions: Heart Failure and Coronary Artery Disease; Circulatory System

• Registration Number: ISRCTN78985727
• Lead Sponsor: East and North Hertfordshire NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 105

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end-point within each group will be the change in platelet reactivity and thrombolytic status from baseline, following treatment with epleronone.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration