coronary artery disease
Conditions
Interventions
Trade Name: Prednsiolone EC 5mg
Product Name: prednisolone EC
Product Code: Prednisolone EC
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the pl
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The peri-procedural use of oral corticosteroids in elective/acute patients undergoing percutaneous coronary intervention for coronary artery disease reduces the incidence of in-segment re-stenosis.;Secondary Objective: N/A;Primary end point(s): Primary end point Angiographically documented in-segment re-stenosis. | — |
Countries
United Kingdom
Outcome results
None listed