World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 31 January 2017
Main ID:  EUCTR2010-022134-89-LV
Date of registration: 26/09/2013
Prospective Registration: Yes
Primary sponsor: I.R.I.S.
Public title: Efficacy and safety of trimetazidine in patients with angina having been treated by dilatation of coronary arteries.
Scientific title: The efficAcy and safety of Trimetazidine in Patients with angina pectoris having been treated by percutaneous Coronary Intervention. ATPCI study An international, multicentre, randomised, double-blind, placebo-controlled study in patients treated for 2 to 4 years.
Date of first enrolment: 04/12/2013
Target sample size: 10300
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022134-89
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Algeria Argentina Armenia Austria Belarus Bosnia and Herzegovina Brazil Bulgaria
Canada Chile China Colombia Croatia Czech Republic Denmark Egypt
Estonia France Georgia Germany Greece Hungary Indonesia Italy
Jordan Kazakhstan Korea, Republic of Latvia Lebanon Lithuania Macedonia, the former Yugoslav Republic of Malaysia
Mexico Montenegro Morocco Netherlands Peru Philippines Poland Portugal
Romania Russian Federation Serbia Singapore Slovakia Slovenia South Africa Spain
Switzerland Thailand Tunisia Turkey Ukraine Vietnam
Contacts
Name: Clinical Studies Department   
Address:  50 rue Carnot 92284 Suresnes France
Telephone: 01.55.72.43.66
Email: helene.rault@fr.netgrs.com
Affiliation:  Institut de Recherches Internationales Servier
Name: Clinical Studies Department   
Address:  50 rue Carnot 92284 Suresnes France
Telephone: 01.55.72.43.66
Email: helene.rault@fr.netgrs.com
Affiliation:  Institut de Recherches Internationales Servier
Key inclusion & exclusion criteria
Inclusion criteria:
Women or men = 21 years old and < 85 years old of any ethnic origin
Patients presenting a single or multivessel coronary artery disease and having undergone PCI treating at least one stenosis to either a native coronary artery or a coronary graft where the PCI was:
- indicated because of angina pectoris occurring either in the context of stable angina (elective PCI) or in the context of an acute presentation such as unstable angina/NSTEMI, but excluding STEMI,
- achieved by stent implantation or by other acceptable interventional means,
- successful as planned by the operator and with no further revascularization (either percutaneous or surgical) planned,
- uncomplicated such that the patient's discharge was not, or will not be, delayed because of a cardiac or cerebrovascular problem
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 5900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4400

Exclusion criteria:
- Severe uncontrolled rythm disturbances including paroxysmal VT and SVT
- Kown severe aortic or mitral valve disease
- Clinical signs and/or symptoms of heart failure corresponding to NYHA class IV
- Hypertrophic obstructive cardiomyopathy or other forms of left ventricular outflow tract obstruction
- Active myocarditis, pericarditis or endocarditis
- Hystory of agranulocytosis, severe thrombocytopenia or severe coagulation disorder
- History of pulmonary embolism within preceding 6 months
- Known severe uncontrolled arterial hypertension
- Known chronic severe or moderate renal failure, with sCrCl < 60 mL/min or eGFR<60 mL/min/1.73m2
- Current or previous movement disorders such as Parkinsonian symptoms, restless leg syndrome, tremor, gait instability of central origin


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Patients with Angina pectoris having been treated by Percutaneous Coronary Intervention
MedDRA version: 16.0 Level: PT Classification code 10002383 Term: Angina pectoris System Organ Class: 10007541 - Cardiac disorders
Intervention(s)

Trade Name: VASTAREL MR 35mg
Product Name: S06790
Product Code: S06790
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: TRIMETAZIDINE DIHYDROCHLORIDE
CAS Number: 13171-25-0
Current Sponsor code: S06790
Other descriptive name: TRIMETAZIDINE DIHYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 35-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: Demonstrate the superiority of trimetazidine over placebo in preventin recurrence or exacerbation of angina pectoris and reducing cardiac events, and to document its safety by analysing the occurrence of serious adverse events
Secondary Objective: Evaluate the effect of trimetazidine on the other efficacy endpoints as well as the other safety parameters, clinical and biological
Timepoint(s) of evaluation of this end point: all over the study
Primary end point(s): Time to first occurrence of an event in the composite of:
- Cardiac death
- Hospitalisation for a cardiac event
- Recurrent or persistent angina leading to adding, switching or increasing the dose of one of the evidence-based antianginal therapies
- Recurrent or persistent angina leading to performing a coronary angiography
Secondary Outcome(s)
Secondary end point(s): Secondary efficacy endpoints and safety
Timepoint(s) of evaluation of this end point: All over the study
Secondary ID(s)
2010-022134-89-HU
CL3-06790-010
Source(s) of Monetary Support
ADIR
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history