A phase III study to determine whether Cyclosporine A improves outcomes after successful primary angioplasty, by improving myocardial reperfusion.

Conditions: All (male and female) patients, aged over 18, presenting with a large STEMI not older than 4 hours (defined as angina pectoris or equivalent symptoms of more than 30 minutes duration within the last 4 hours and a sum of ST-elevation > 4mm), with a TIMI-flow 0 or 1 in the identified culprit artery, for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI) are eligible for the study.
MedDRA version: 14.0Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-002876-18-IT

Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 444

Inclusion Criteria

All (male and female) patients, aged over 18, presenting with a large STEMI within 4 hours of onset (defined as angina pectoris or equivalent symptoms of more than 20 minutes duration within the last 4 hours and ST elevation in = 3 leads in anterior MI and/or a deviation in = 4 leads in inferior MI, with a TIMI-flow 0 or 1 in the culprit artery, committed to treatment with PCI) are eligible for the study. Patients will only be included if they are able to understand the nature, scope, and possible consequences of study participation, and written informed consent will be sought.
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 264
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

Left bundle branch block; TIMI-flow >1 in the identified culprit artery; current (= 10 days) treatment with CsA or contraindication regarding treatment with CsA; coronary anatomy not suitable for PCI; thrombolytic therapy within 24 hrs. before randomization; previous myocardial infarction; previous CABG; severe renal or hepatic insufficiency; malignant tumor, not curatively treated; women with childbearing potential, esp. pregnant or nursing women; participation in another clinical or device trial within the previous 30 days.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the present study is improvement of myocardial reperfusion, measured with ST-segment resolution >=70% 1 hour after PCI.;Secondary Objective: High sesnsitive troponin T (hsTnT) at day 4 after PCI. All-cause mortality, HF or shock within 6 months of randomization; re-hospitalization for CV reasons within 6 months of randomization.;Primary end point(s): Improvement of myocardial reperfusion, measured with ST-segment resolution >=70%;Timepoint(s) of evaluation of this end point: 1 hour after PCI.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Troponin (hsTnT) at day 4 after PCI, all-cause mortality, HF or shock within 6 months of randomization; re-hospitalization for CV reasons.;Timepoint(s) of evaluation of this end point: Troponin T: 4 hours; Echocardiography: pre-discharge and 6 months