Condition category
Circulatory System
Date applied
09/06/2011
Date assigned
18/10/2011
Last edited
01/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paolo G. Camici

ORCID ID

Contact details

San Raffaele University
Insititute of Science
Via Olgettina 60
Milan
20132
Italy

Additional identifiers

EudraCT number

2011-000783-98

ClinicalTrials.gov number

Protocol/serial number

CL2-16257-095

Study information

Scientific title

Effects of oral administration of ivabradine (7.5 mg bid) on post-ischaemic stunning induced by exercise stress in patients with coronary artery disease and exercise inducible ischaemia

Acronym

Study hypothesis

To assess the effects of ivabradine on post-ischaemic stunning induced by exercise stress in patients with stable coronary artery disease and exercise-inducible ischaemia

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Exploratory open label study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary artery disease

Intervention

1. Two film-coated tablets of 7.5 mg or 5 mg of ivabradine
2. Control: placebo bid

Intervention type

Drug

Phase

Not Applicable

Drug names

Ivabradine

Primary outcome measures

1. Myocardial stunning, by evaluating changes in regional wall motion measuring 2D Strain/Strain rate
2. Measured at selection visit, inclusion visit and end of treatment visit

Secondary outcome measures

1. Arterial elastance (measured at selection visit, inclusion visit and end of treatment visit)
2. Ventricular arterial coupling (measured at selection visit, inclusion visit and end of treatment visit)
3. Safety (measured at each visit)

Overall trial start date

01/09/2011

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 30 to 75 years
2. Male or female
3. Evidence of coronary artery disease proven by clinical history
4. Sinus rhythm and resting heart rate equal or higher than 70 bpm
5. Exercise-inducible myocardial ischaemia
6. Myocardial stunning, assessed by cardiac echocardiography

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

1. Angina at rest or angina class IV
2. Unstable cardiovascular condition
3. Previous treament with anti-anginal medication within 1 week before inclusion
4. Significant abnormalities in the laboratory blood evaluation
5. Contra-indication to the administration of ivabradine

Recruitment start date

01/09/2011

Recruitment end date

30/09/2012

Locations

Countries of recruitment

Italy

Trial participating centre

San Raffaele University
Milan
20132
Italy

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes