The STARS (STeroids Against Re-Stenosis) Trial[THE USE OF Peri-PROCEDURAL ORAL CORTICOSTERIODS TO PREVENT IN-SEGMENT RESTENOSIS AFTER PERCUTANEOUS CORONARY INTERVENTION.] - The STARS Trial

Phase 1

• Conditions: coronary artery disease

• Registration Number: EUCTR2004-002304-16-GB
• Lead Sponsor: South Tees Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-05-27
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 548

Inclusion Criteria

Any patient awaiting percutaneous coronary intervention for symptomatic coronary artery disease (elective or acute).
Documented myocardial ischaemia.
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).

Ammendment: Any lesion for which the operator (interventional consultant cardiologist) feels a non-drug eluting stent is appropriate
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Left Main Stem stenosis
PCI for ST elevation myocardial infarction
Steroid therapy within 30-days of study enrolment.
Contraindication to corticosteroid use.
Previous inclusion in this study.
Non-cardiac disease likely to cause death within 6-months.
(Proposed use of a drug eluting stent.) Ammendment: Proposed use of a drug eluting stent (in the study lesion(s)).
Inter-hospital transfers from Cumbria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified