Condition category
Circulatory System
Date applied
04/09/2006
Date assigned
24/10/2006
Last edited
06/01/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.enherts-tr.nhs.uk/default.htm

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes