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

ISRCTN	ISRCTN78985727
DOI	https://doi.org/10.1186/ISRCTN78985727
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Diana Gorog
Scientific

Cardiology Department
Queen Elizabeth II Hospital
Howlands
Welwyn Garden City
AL7 4HQ
United Kingdom

Phone	+44 (0) 1707 365 551
Email	dgorog@aol.com

Study design	Prospective, double-blind, randomised study with a cross-over design.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Epleronone attenuates platelet reactivity, and enhances endogenous fibrinolytic status in patients with Heart Failure (HF) and Coronary Artery Disease (CAD).
Ethics approval(s)	Application submitted to Hertfordshire 2 Research Ethics Committee (REC Ref: 06/Q0204/102), next meeting due 11 November 2006.
Health condition(s) or problem(s) studied	Heart Failure and Coronary Artery Disease
Intervention	Epleronone or placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/11/2006
Completion date	30/10/2007
Reason abandoned (if study stopped)	Lack of funding

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	105
Key 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
Key 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
Date of first enrolment	01/11/2006
Date of final enrolment	30/10/2007

Cardiology Department

Welwyn Garden City
AL7 4HQ
United Kingdom

East and North Hertfordshire NHS Trust (UK)
Hospital/treatment centre

Howlands
Welwyn Garden City
AL7 4HQ
England
United Kingdom

Website	http://www.enherts-tr.nhs.uk/default.htm
"ROR"	https://ror.org/02ryc4y44

Government

Local Research and Development funding from East and North Hertfordshire NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan