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
Secondary identifying numbers CTA number: 22011/0001/001-0001
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

Study designDouble blind 2 x 2 randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe STARS (STeroids Against Re-Stenosis) trial: the use of peri-procedural oral corticosteriods to prevent in-segment re-stenosis after percutaneous coronary intervention
Study acronymThe STARS (STeroids Against Re-Stenosis) trial
Study objectives1. 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) studiedAtherosclerosis
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Corticosteroids
Primary outcome measureAngiographically documented in-segment re-stenosis.
Secondary outcome measures1. 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 study start date01/01/2006
Completion date01/01/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants548
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2006
Date of final enrolment01/01/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

South Tees Hospitals NHS Trust (UK)
Hospital/treatment centre

c/o Dr David R Chadwick
Head of Research and Development
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom

Email DavidRChadwick@stees.nhs.uk
Website http://www.southtees.nhs.uk/
ROR logo "ROR" https://ror.org/02js17r36

Funders

Funder type

Government

South Tees Hospitals NHS Trust (UK) - Cardiothoracic Directorate Research and Development Department

No information available

Guidant Corporation (UK)

No information available

Cordis Corporation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

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