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Ivabradine IN IMPROVING THE EFFECTIVENESS OF THE ENDOTHELIAL FUNCTION IN PATIENTS WITH CAD undergoing coronary angioplasty

Heart Rate reduction by IVabradine for improvement of ENDothELial function in patients with coronary artery disease: the RIVENDEL study - RIVENDEL

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005359-18-IT
Enrollment
Unknown
Registered
2012-12-21
Start date
2013-01-22
Completion date
Unknown
Last updated
2013-08-05

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

Conditions

PATIENTS WITH CAD AFTER CORONARY ANGIOPLASTY MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: CORLENTOR*14CPR RIV 5MG ALL/PV Pharmaceutical Form: Tablet CAS Number: 155974-00-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-

Sponsors

UNIVERSITA' CAMPUS BIOMEDICO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): INCIDENCE OF MACE;Timepoint(s) of evaluation of this end point: 8 WEEKS—

Countries

Italy

Contacts

Public ContactCARDIOLOGIA

POLICLINICO UNIVERSITARIO CAMPUS BIO-MEDICO DI ROMA

f.mangiacapra@unicampus.it06225411612

Outcome results

None listed

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