Clinical acceptability of trimetazidine 80 mg once daily compared to trimetazidine 35 mg twice daily in patients with chronic stable angina pectoris

ISRCTN	ISRCTN84362208
DOI	https://doi.org/10.1186/ISRCTN84362208
Protocol serial number	CL3-06795-008
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 05/03/2012
Registration date: 04/04/2012
Last edited: 21/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Prof Yuri M Pozdnyakov
Scientific

Moscow Regional Cardiology Centre
Zhukovsky
Frunze Street, 1
Moscow
140180
Russian Federation

Study information

Primary study design	Interventional
Study design	International multicentre randomised double-blind parallel-group study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Clinical acceptability of trimetazidine 80 mg once daily compared to trimetazidine 35 mg twice daily in patients with chronic stable angina pectoris: a multicentre randomised double blind study
Study objectives	To compare the clinical acceptability of trimetazidine 80mg once daily with trimetazidine 35 mg twice daily
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	Angina pectoris attacks
Intervention	A randomised, double-blind, parallel-group study in patients treated for 12 weeks - Two arms: trimetazidine MR 80mg once daily or trimetazidine MR 35mg twice daily
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Trimetazidine
Primary outcome measure(s)	1. Emergent adverse events 2. Blood pressure 3. Weight 4. Laboratory examinations: biochemical and haematological parameters 5.12-lead electrocardiogram 6. CCS classification of symptoms of angina pectoris
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Key inclusion criteria	1. Male or female patient 2. More than or equal to 21 years old 3. Any ethnic origin 4. Patients with a prior diagnosis of stable angina pectoris of effort
Key exclusion criteria	1. History of acute coronary syndrome within previous 3 months 2. Coronary revascularisation procedure within previous 3 months 3. Canadian Cardiovascular Society (CCS) class 4 angina pectoris
Date of first enrolment	12/03/2012
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Russian Federation
Serbia

Study participating centre

Moscow Regional Cardiology Centre

Moscow
140180
Russian Federation

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2018		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Poster results	poster presentation	27/08/2016		No	No

Editorial Notes

21/05/2018: Publication reference added.
18/04/2018: Internal review.
28/03/2018: The publication and dissemination plan has been changed.
24/01/2018: Publication plan and IPD sharing statement added.
06/12/2017: results summary and publication reference added.