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

Not Applicable

Completed

• Conditions: Atherosclerosis; Circulatory System

• Registration Number: ISRCTN05886349
• Lead Sponsor: South Tees Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-02
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 548

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Angiographically documented in-segment re-stenosis.

Secondary Outcome Measures

Name	Time	Method
1. Late loss <br>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<br>3. Target vessel revascularisation: defined as repeat intervention within the same epicardial coronary artery<br>4. Target vessel failure: target vessel revascularisation plus any peri-procedural complication related to the procedure<br>5. Myocardial Infarction (MI) related to the target vessel<br>6. Incidence of death<br>7. Unstable angina, congestive cardiac failure<br>8. Non-fatal MI<br>9. Q wave MI<br>9. Non-Q wave MI<br>10. Cardio-Vascular Accident (CVA)<br>11. Intracranial haemorrhage<br>12. Infarction<br>13. Repeat hospitalisation<br>14. Major/minor bleeding complications<br>15. Poor glycaemic control