Main
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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:
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EUCTR |
Last refreshed on:
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1 February 2020 |
Main ID: |
EUCTR2010-022134-89-ES |
Date of registration:
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01/10/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and safety of trimetazidine in patients with angina having been treated by dilatation of coronary arteries.
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Scientific title:
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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.
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Date of first enrolment:
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11/11/2013 |
Target sample size:
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10300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022134-89 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Algeria
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Argentina
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Armenia
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Austria
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Belarus
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Bosnia and Herzegovina
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Brazil
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Bulgaria
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Canada
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Chile
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China
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Colombia
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Croatia
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Czech Republic
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Denmark
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Egypt
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Estonia
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France
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Georgia
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Germany
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Greece
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Hungary
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Indonesia
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Italy
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Jordan
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Kazakhstan
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Korea, Republic of
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Latvia
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Lebanon
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Lithuania
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Macedonia, the former Yugoslav Republic of
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Malaysia
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Mexico
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Montenegro
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Morocco
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Netherlands
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Peru
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Philippines
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Singapore
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Slovakia
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Slovenia
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South Africa
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Spain
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Switzerland
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Thailand
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Tunisia
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Turkey
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Ukraine
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Vietnam
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Contacts
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Name:
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Clinical Studies Department
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Address:
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50 rue Carnot
92284
Suresnes
France |
Telephone:
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33 1.55.72.43.66 |
Email:
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helene.rault@fr.netgrs.com |
Affiliation:
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Institut de Recherches Internationales Servier |
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Name:
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Clinical Studies Department
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Address:
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50 rue Carnot
92284
Suresnes
France |
Telephone:
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33 1.55.72.43.66 |
Email:
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helene.rault@fr.netgrs.com |
Affiliation:
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Institut de Recherches Internationales Servier |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women or men greater than or equal 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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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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
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Intervention(s)
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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
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Primary Outcome(s)
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Secondary Objective: Evaluate the effect of trimetazidine on the other efficacy endpoints as well as the other safety parameters, clinical and biological
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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
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Timepoint(s) of evaluation of this end point: all over the study
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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
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: All over the study
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Secondary end point(s): Secondary efficacy endpoints and safety
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Secondary ID(s)
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2010-022134-89-HU
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CL3-06790-010
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Source(s) of Monetary Support
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ADIR
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Ethics review
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Status: Approved
Approval date: 07/11/2013
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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