Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

There is no data that heart rate reduction reduces periprocedural myocardial injury in patients undergoing elective percutaneous coronary intervention (angiography of coronary vessels with subsequent stent implantation in narrowed segments in order to reestablish normal blood flow through coronary vessels). Ivabradine is an established drug that reduces heart rate (HR) and subsequently alleviates symptoms of angina (heart pain due to coronary stenoses). In this study we sought to determine whether HR reduction via ivabradine attenuates or reduces the amount of myocardial injury that in small extent occurs during stent implantation.

they were eligible if heart rate was above 70/min and afterwards randomized in two groups (ivabradine group and control group)
40 patients with stable angina and resting heart rate above 70 beats per minute (bpm) were assigned to ivabradine 5 mg twice daily. The control group consisted of 40 patients with resting heart rate above 70 bpm. All patients were included 1 month before scheduled intervention. After admission troponin I levels (blood marker of myocardial damage or injury) were measured before the procedure and after 24 hours. We also collected data of any change in symptoms in both groups.

The benefit was that patients were examined more frequently; also the clinical benefit of treatment with ivabradine was previously proven and the prescription was in line with guidelines for treatment of patients with ischemic heart (coronary) disease. There were no potential additional risks for included patients.

Trial website

Contact information



Primary contact

Dr Franjo Naji


Contact details

Ljubljanska ulica 5
+386 (0)23212371

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effect of heart rate reduction on periprocedural myocardial injury and angina symptoms in elective patients with coronary disease undergoing coronary intervention


Study hypothesis

Heart rate reduction via ivabradine treatment reduces periprocedural myocardial injury and reduces symptoms in patients with stable coronary disease undergoing interventional coronary procedure.

Ethics approval

Institutional ethics committee University Clinical center Maribor, 05/05/2010, approval Nr: 092-30/2010

Study design

Single-center interventional study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Ischemic heart disease with stable angina


After inclusion criteria were met patients were invited to participate in study. Informed consent was obtained, and patients were instructed to attend first visit one month before planned procedure. At first visit heart rate was reassessed. Patients were asked about their usual therapy adherence and then instructed to rest for five minutes. 12-lead ECG was recorded and if eligible (heart rate > 70 bpm) patients were then randomly assigned to one of two groups. Patients were randomized so that the first patient was in group 1 and the second was in group 2 and so on. Patients in group 1 were prescribed ivabradine 5 mg twice daily on top of their standard therapy and patients in group 2 received no additional treatment. Treatment with ivabradine wasn't stopped after the study conclusion. There was no long-term follow-up or additional visits for the patients included in the protocol, patients had regular visits based on their clinical characteristics.

Intervention type



Phase IV

Drug names


Primary outcome measure

Periprocedural myocardial injury, measured using cardiac troponin I assay (Siemens Healthcare Diagnostics) from blood samples at admission (before the procedure) and 24 hours after the procedure

Secondary outcome measures

Symptoms of angina, assessed with the number of angina attacks (chest pain) per week, on the day of inclusion and 1 month after the inclusion

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Patients scheduled for elective PCI
2. Suspected or established coronary artery disease
3. Presence of sinus rhythm
4. Resting heart frequency above 70 beats per minute

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Previous pacemaker implantation
2. Symptoms and signs of heart failure
3. Ejection fraction of left ventricle below 50%
4. Levels of creatinine above upper level of normal (ULN)
5. Already treated with ivabradine

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University clinical center Maribor
Ljubljanska 5
2000 Maribor

Sponsor information


University clinical center Maribor

Sponsor details

Dpt of cardiology
Ljubljanska 5

Sponsor type

Hospital/treatment centre



Funder type


Funder name


Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

The trialists plan to publish the data in an original article in a peer-reviewed journal with an impact factor as soon as possible.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Franjo Naji ( in anonymised form in an Excel table. The decision to share data depends on the type of inquiry and person involved. No special consent of patients to share the data.

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

There were no significant differences between both groups. We noticed significant reduction of heart rate and angina episodes per week in the ivabradine group (62.3±7.1 bpm vs.79±10.2 bpm; P<0.05 and 0.5±1.5 vs. 2.4±2.1; P<0.05). The mean troponin I levels after the procedure were significantly lower in the ivabradine group compared to the control group (0.1±0.3 ng/mL vs. 0.5±0.9 ng/mL; P<0.05). When analyzing patients with performed coronary intervention the only significant predictors of PMI after adjustment for potential confounders in multivariable logistic model were heart rate under 70 bpm (OR 7.0; CI 1.2 to 41.7; P=0.03) and number of deployed stents (OR4.4; 95% CI 1.1 to 17.3; P=0.03).

Publication list


Publication citations

Additional files

Editorial Notes