Efficacy and safety of trimetazidine in patients with angina having been treated by dilatation of coronary arteries.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022134-89-HU

Enrollment

10300

Registered

2013-09-11

Start date

2013-11-21

Completion date

Unknown

Last updated

2014-04-28

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

Conditions

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

Interventions

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 Sp

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women or men = 21 years old and =65 years) yes F.1.3.1 Number of subjects for this age range 4400

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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;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;Timepoint(s) of evaluation of this end point: all over the study	—

Measure

Time frame

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;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;Timepoint(s) of evaluation of this end point: all over the study

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoints and safety ;Timepoint(s) of evaluation of this end point: All over the study	—

Countries

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

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

helene.rault@fr.netgrs.com01.55.72.43.66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 26, 2026