Contact information
Type
Scientific
Primary contact
Dr Andrew Turley
ORCID ID
Contact details
The James Cook University Hospital
Department of Cardiology
Cardiothoracic Research Department
Red Portacabin
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
-
a.turley@btopenworld.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CTA number: 22011/0001/001-0001
Study information
Scientific title
The STARS (STeroids Against Re-Stenosis) trial: the use of peri-procedural oral corticosteriods to prevent in-segment re-stenosis after percutaneous coronary intervention
Acronym
The STARS (STeroids Against Re-Stenosis) trial
Study hypothesis
1. The peri-procedural use of oral corticosteroids in elective/acute patients undergoing percutaneous coronary intervention reduces the incidence of in-segment re-stenosis
2. The use of a chromium cobalt stent results in lower restenosis rates than bare metal stents in elective/acute patients undergoing percutaneous coronary intervention
Ethics approval
London Multicentre Research Ethics Committee (MREC), 05/05/2005, ref: 04/MREC2/061
Study design
Double blind 2 x 2 randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Atherosclerosis
Intervention
1. Prednisolone versus placebo
2. Chromium cobalt stent versus stainless steel stents
Steroid randomisation procedure:
Acute cases: patients will be randomised via block randomisation 24 hours before their procedure and assigned to the respective study arms by a closed envelope system
Elective cases: patients will be randomised via block randomisation at the time of their pre-admission clinic attendance (one-week prior to the procedure) and assigned to the respective study arms by a closed envelope system
Stent randomisation procedure:
Acute and elective cases: patients will be randomised via block randomisation at the time of their percutaneous coronary intervention procedure if no exclusion criteria are met and assigned to the respective study arms by a closed envelope system.
Steroid protocol:
Patients will be randomised to oral prednisolone or placebo. Patients will receive prednisolone 40 mg to start 24 hours pre-procedure and to continue for a total of 28-days.
Due to dual oral antiplatelet therapy plus oral corticosteroid use, all patients will receive empirical proton pump inhibitor cover (lansoprazole 15 mg/day for 28 days) for the duration of the corticosteroid course (advice taken from a consultant gastroenterologist).
Protocol for steroid withdrawal/step-down:
Due to the potential risk of adrenal suppression all patients will receive a step-down approach for steroid withdrawal. For the first 14 days patients will receive 40 mg prednisolone. The dose will then be tailed off over the next 14 days as shown below:
Day 1 to 14 = 40 mg
Day 15 to 19 = 20 mg
Day 20 to 24 = 10 mg
Day 25 to 28 = 5 mg
Registry:
Patients' full eligibility for study participation will not be known until the time of coronary angiography as a major inclusion criteria is a lesion of a reference diameter vessel greater than or equal to 3 mm. Lesions less than 3 mm are an exclusion criteria as National Institute for Clinical Excellence (NICE) guidelines advise the use of drug eluting stents in this setting. Therefore some patients will receive study medication up to this point. A registry will be kept of these patients and they will be followed up clinically (via telephone) but not angiographically.
Intervention type
Drug
Phase
Not Applicable
Drug names
Corticosteroids
Primary outcome measure
Angiographically documented in-segment re-stenosis.
Secondary outcome measures
1. Late loss
2. Target lesion revascularisation: defined as repeat intervention of re-stenotic lesions, which include the target site of the stent implantation or 5 mm proximal and distal in the same epicardial coronary artery
3. Target vessel revascularisation: defined as repeat intervention within the same epicardial coronary artery
4. Target vessel failure: target vessel revascularisation plus any peri-procedural complication related to the procedure
5. Myocardial Infarction (MI) related to the target vessel
6. Incidence of death
7. Unstable angina, congestive cardiac failure
8. Non-fatal MI
9. Q wave MI
9. Non-Q wave MI
10. Cardio-Vascular Accident (CVA)
11. Intracranial haemorrhage
12. Infarction
13. Repeat hospitalisation
14. Major/minor bleeding complications
15. Poor glycaemic control
Overall trial start date
01/01/2006
Overall trial end date
01/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Any patient awaiting percutaneous coronary intervention for symptomatic coronary artery disease (elective or acute)
2. Documented myocardial ischaemia
3. Coronary angiography demonstrating at least a 50% reduction of the luminal diameter in at least one native coronary artery (as measured by quantitative computerised angiography)
4. Any lesion more than 3 mm diameter
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
548
Participant exclusion criteria
1. Proposed use of a drug eluting stent (in the study vessel[s])
2. Left Main Stem stenosis
3. Primary Percutaneous Coronary Intervention (PCI) for ST elevation myocardial infarction
4. Steroid therapy within 30-days of study enrolment
5. Contraindication to corticosteroid use
6. Previous inclusion in this study
7. Non-cardiac disease likely to cause death within six months
8. Inter-hospital transfers from Cumbria
Recruitment start date
01/01/2006
Recruitment end date
01/01/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
South Tees Hospitals NHS Trust (UK)
Sponsor details
c/o Dr David R Chadwick
Head of Research and Development
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
-
DavidRChadwick@stees.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Tees Hospitals NHS Trust (UK) - Cardiothoracic Directorate Research and Development Department
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Guidant Corporation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cordis Corporation (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
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27135149