Condition category
Circulatory System
Date applied
03/10/2006
Date assigned
02/08/2007
Last edited
19/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.southtees.nhs.uk/

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27135149

Publication citations

Additional files

Editorial Notes

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