Cortisone Eliminates Restenosis as Effectively As DES - CEREA-DES

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000770-75-IT

Enrollment

Registered

2006-04-21

Start date

2005-11-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To assess the clinical efficacy and safety of the prednisone therapy after PCI as a low-tech low-cost systemic alternative to currently available BMS and DES. MedDRA version: 6.1 Level: PT Classification code 10056489

Interventions

Trade Name: DELTACORTENE FTE 10 CPR 25MG Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with diagnosed CAD either SVD or MVD with signs or symptoms of myocardial ischemia, scheduled for percutaneous revascularization are all candidates. Either native vessels and SVG can be included with de-novo or restenotic lesions. Lesions causing a diameter stenosis 50 in a main coronary artery LAD, RCA, LCx or their principal branches Dg, OM, PL, PDA . Chronic total occlusions successfully recanalized and completely covered with stents with optimal angiographic result and normal TIMI 3 grade flow at the end of the procedure. Stenting or balloon dilatation of small vessels 2.5 to 2.75mm is allowed. Use of rotational devices does not preclude inclusion in the study if a stent is successfully placed after either, DCA or rotablation. Use of multiple stents or balloon PCI to treat bifurcation lesions provisional, Y, T, kissing or crushing is permitted. Stenting the main branch and provisional stenting for the side branch should be the preferred initial approach. 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Diabetes Age over 80 years old Recent Q wave myocardial infarction less than 2 weeks Severe hypertension, uncontrolled despite medical treatment Gastric ulcer or symptomatic gastritis Active infective disease Neoplasia Suboptimal angiographic result of PCI DS 30 or TIMI flow grade 3

Design outcomes

Primary

Measure	Time frame
Main Objective: is the comparison of the primary endpoint obtained in a control group of patients treated with BMS versus two alternative study groups - DES - BMS and oral prednisone All assuming a similar adjunctive conventional medical treatment.;Secondary Objective: - cost-effectiveness analysis. This will be calculated considering all patients. This project will be subsequently presented as an amendment . - comparison of the angiographic results. This will be calculated in a representative sub-sample.;Primary end point(s): the primary endpoint of the study will be the occurrence of major clinical events MACE at 12 months.	—

Measure

Time frame

Main Objective: is the comparison of the primary endpoint obtained in a control group of patients treated with BMS versus two alternative study groups - DES - BMS and oral prednisone All assuming a similar adjunctive conventional medical treatment.;Secondary Objective: - cost-effectiveness analysis. This will be calculated considering all patients. This project will be subsequently presented as an amendment . - comparison of the angiographic results. This will be calculated in a representative sub-sample.;Primary end point(s): the primary endpoint of the study will be the occurrence of major clinical events MACE at 12 months.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026