The STARS (steroids against re-stenosis) trial: the use of peri-procedural oral corticosteriods to prevent in-segment re-stenosis after percutaneous coronary intervention

ISRCTN	ISRCTN05886349
DOI	https://doi.org/10.1186/ISRCTN05886349
Protocol serial number	CTA number: 22011/0001/001-0001
Sponsor	South Tees Hospitals NHS Trust (UK)
Funders	South Tees Hospitals NHS Trust (UK) - Cardiothoracic Directorate Research and Development Department, Guidant Corporation (UK), Cordis Corporation (UK)

Submission date: 03/10/2006
Registration date: 02/08/2007
Last edited: 19/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew Turley
Scientific

The James Cook University Hospital
Department of Cardiology
Cardiothoracic Research Department
Red Portacabin
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Email	a.turley@btopenworld.com

Study information

Primary study design	Interventional
Study design	Double blind 2 x 2 randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	The STARS (STeroids Against Re-Stenosis) trial
Study objectives	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(s)	London Multicentre Research Ethics Committee (MREC), 05/05/2005, ref: 04/MREC2/061
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Corticosteroids
Primary outcome measure(s)	Angiographically documented in-segment re-stenosis.
Key secondary outcome measure(s)	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
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	548
Key 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
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	01/01/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The James Cook University Hospital

Middlesbrough
TS4 3BW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/05/2016: Internal review
05/05/2016: Publication reference added.