Contact information
Type
Scientific
Primary contact
Dr Diana Gorog
ORCID ID
Contact details
Cardiology Department
Queen Elizabeth II Hospital
Howlands
Welwyn Garden City
AL7 4HQ
United Kingdom
+44 (0) 1707 365 551
dgorog@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Epleronone attenuates platelet reactivity, and enhances endogenous fibrinolytic status in patients with Heart Failure (HF) and Coronary Artery Disease (CAD).
Ethics approval
Application submitted to Hertfordshire 2 Research Ethics Committee (REC Ref: 06/Q0204/102), next meeting due 11 November 2006.
Study design
Prospective, double-blind, randomised study with a cross-over design.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Heart Failure and Coronary Artery Disease
Intervention
Epleronone or placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Epleronone
Primary outcome measure
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
Not provided at time of registration
Overall trial start date
01/11/2006
Overall trial end date
30/10/2007
Reason abandoned (if study stopped)
Lack of funding
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
105
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
30/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiology Department
Welwyn Garden City
AL7 4HQ
United Kingdom
Sponsor information
Organisation
East and North Hertfordshire NHS Trust (UK)
Sponsor details
Howlands
Welwyn Garden City
AL7 4HQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Local Research and Development funding from East and North Hertfordshire NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list