Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436121377
Study information
Scientific title
Acronym
Study hypothesis
To define the effects that angiotensin-converting enzyme inhibitors have on circulating levels of the pro-inflammatory cytokines; tumour necrosis factor (TNF)-alpha and interleukin-6 (IL-6), and the anti-inflammatory cytokine; IL-10.
Ethics approval
Not provided at time of registration
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Acute coronary syndrome
Intervention
Randomised controlled trial. Random allocation to:
1. Standard management
2. Standard management + angiotensin-converting enzyme inhibitor
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Cytokine levels measured in the blood peripheral venous blood
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/10/2002
Overall trial end date
31/10/2005
Reason abandoned
Eligibility
Participant inclusion criteria
The patient population will be drawn from all patients admitted to the cardiac unit based at the Leeds General Infirmary or St James's University Hospital with chest pain within the preceding 24 h. Patients must have a history and electrocardiogram (ECG) changes consistent with a diagnosis of the Acute Coronary Syndrome.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Patients with ST elevation myocardial infarction
Recruitment start date
31/10/2002
Recruitment end date
31/10/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute for Cardiovascular Research
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals 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