Ivabradine IN IMPROVING THE EFFECTIVENESS OF THE ENDOTHELIAL FUNCTION IN PATIENTS WITH CAD undergoing coronary angioplasty
- Conditions
- PATIENTS WITH CAD AFTER CORONARY ANGIOPLASTYMedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-005359-18-IT
- Lead Sponsor
- IVERSITA' CAMPUS BIOMEDICO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
ISCHEMIC HEART DISEASE PATIENTS TREATED WITH CORONARY ANGIOPLASTY AND ON TOP OF MEDICAL TREATMENT
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
Patients with resting heart rate <60 bpm.
Patients undergoing revascularization for STEMI.
Patients with severe left ventricular dysfunction (ejection fraction = 35%).
Patients with chronic renal failure, severe (GFR <60 ml / min).
Patients with liver disease.
Patients with atrial fibrillation and atrial flutter.
Patients with pacemakers.
Patients with disease of the sinoatrial node, sinoatrial block, long QT syndrome, complete AV block.
Patients with chronic inflammatory disease and cancer.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: EFFECTIVENESS OF treatment with ivabradine ON ENDOTHELIAL FUNCTION IN PATIENTS WITH CAD UNDERWENT TO CORONARY ANGIOPLASTY;Secondary Objective: INCIDENCE O FMACE;Primary end point(s): EVALUATION OF ENDOTHELIAL MARKER FUNCTION AND INFLAMMATORY INDICES IN THE TIMING OF THE STUDY;Timepoint(s) of evaluation of this end point: FIRST ASSESSMENT TO 4 WEEKS AND THEN TO 8 WEEKS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): INCIDENCE OF MACE;Timepoint(s) of evaluation of this end point: 8 WEEKS