Long-term (3 years) ophthalmic safety and cardiac efficacy and safety of ivabradine administered orally at the therapeutic doses (2.5/5/7.5 mg twice daily [b.i.d.]) on top of anti-anginal background therapy, to patients with chronic stable angina pectoris

ISRCTN	ISRCTN99185656
DOI	https://doi.org/10.1186/ISRCTN99185656
EudraCT/CTIS number	2006-005475-17
Secondary identifying numbers	CL3-16257-067

Submission date: 18/01/2008
Registration date: 13/02/2008
Last edited: 21/04/2020

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 Thomas Meinertz
Scientific

Med. Univ. Klinic und Poliklinic - Abt. Für Kardiologie
Martinistr. 52
Hamburg
20246
Germany

Study information

Study design	International, parallel, double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Long-term (3 years) ophthalmic safety and cardiac efficacy and safety of ivabradine administered orally at the therapeutic doses (2.5/5/7.5 mg b.i.d.) on top of anti-anginal background therapy, to patients with chronic stable angina pectoris. An international, double-blind placebo controlled study.
Study objectives	The inhibition of the Hyperpolarization-activated (Ih) current present in the retina by ivabradine administered at the recommended doses leads to transient functional modifications of the retina. As of 23/07/2012, the following changes were made to this record: 1. The anticipated end date was extended from 01/05/2014 to 30/09/2015 2. The target number of participants was reduced from 300 to 100 As of 03/03/2011 the anticipated end date for this trial has been updated from 01/11/2012 to 01/05/2014.
Ethics approval(s)	Ethics approval received from the First Portuguese Ethics Committee on the 15/01/2008
Health condition(s) or problem(s) studied	Chronic stable angina pectoris
Intervention	1. 2.5 mg ivabradine orally (po) 2. 5 mg ivabradine po 3. 7.5 mg ivabradine po 4. Matching placebo Patients will receive treatment for 3 years.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ivabradine
Primary outcome measure	To document the absence of retinal toxicity in chronic stable angina patients assessed by ocular tests performed 2 months after a treatment exposure of 3 years.
Secondary outcome measures	To document the long term cardiac efficacy and general ocular, cardiac and general safety.
Overall study start date	01/03/2008
Completion date	30/09/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Total final enrolment	97
Key inclusion criteria	1. Male or female patients (oral contraception if childbearing potential), aged greater than 18 years or having reached majority if the legal age of majority is above 18 years age and of any ethnic origin 2. Patients in sinus rhythm; resting heart rate greater than 60 beats per minute, with a history of chronic stable angina greater than 3 months before selection, no angina at rest and with a clinically stable angina greater than 3 months, at least 1 angina attack per month during the previous 3 months before selection 3. Patients who accept to undergo repeated visual tests and with a visual acuity greater than 0.5
Key exclusion criteria	1. Contra-indication to the administration of ivabradine 2. Patients with marked ocular conditions (significant altered vision and/or any evolutive underlying disease) known to have an impact on the ocular tests planned in the protocol
Date of first enrolment	01/03/2008
Date of final enrolment	30/09/2015

Locations

Countries of recruitment

Argentina
Australia
Belgium
Finland
Germany
Hungary
Ireland
Portugal
Singapore
Sweden

Study participating centre

Med. Univ. Klinic und Poliklinic - Abt. Für Kardiologie

Hamburg
20246
Germany

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Summary results are published on https://clinicaltrials.servier.com. For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
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 1st January 2014.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Basic results			21/04/2020	No	No

Editorial Notes

21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
28/03/2018: Publication plan and IPD sharing statement amended.
25/01/2018: Publication plan and IPD sharing statement added.
11/12/2017: results summary.