Condition category
Circulatory System
Date applied
19/10/2015
Date assigned
28/10/2015
Last edited
04/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Coronary heart disease (CHD), also known as ischemic heart disease, is one of the leading causes of death, both in Germany and worldwide. CHD develops because of the build-up of fatty deposits (plaque) on the walls of the coronary arteries (the arteries that supply the heart with oxygen-rich blood). When arteries are blocked or narrowed, the heart does not receive enough blood to function properly, which can cause pain and tightness in the chest (angina). There are several types of angina, the most common being stable angina pectoris (AP). When you exercise or become stressed, the heart needs to work harder in order to pump enough oxygen around the body. When a person is suffering from AP, this extra stress on the heart causes severe pain in the chest. This type of angina is usually treated using medications and changing a person’s lifestyle so that they do not put unnecessary strain on the heart. There is a wide range of drugs which can be prescribed to help people with AP (anti-anginal agents). IMPLICOR® is a newly developed anti-anginal agent which combines two different drugs which are commonly used to treat angina: ivabradine (which slows the heart rate by affecting the electrical activity in the heart) and metoprolol (which “blocks” the effect of adrenaline from speeding up the heart rate). The aim of this study is to find out whether IMPLICOR® is an effective treatment for stable AP.

Who can participate?
Adults suffering from stable angina pectoris who are starting treatment with IMPLICOR®.

What does the study involve?
Patients with chronic (long-term) stable angina pectoris who are going to be treated with IMPLICOR® are asked if they would like to take part in the study. Participants attend regular follow-up appointments for four months while they are taking the medication. At one month and four months, patients have their heart rate measured and are interviewed to find out how many angina attacks they have had, if they have had to be admitted to hospital, and any side effects they are experiencing.

What are the possible benefits and risks of participating?
A potential benefit of taking part in the study is that the treatment may help to improve participants’ angina symptoms. There are no significant risks of participating, although there is a minor risk of side-effects from the medications.

Where is the study run from?
Heart Center of the University of Rostock (Germany)

When is the study starting and how long is it expected to run for?
November 2015 to May 2016

Who is funding the study?
Servier Deutschland GmbH (Germany)

Who is the main contact?
Dr Georg Stöckl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Georg Stöckl

ORCID ID

Contact details

Servier Deutschland GmbH
Elsenheimerstr. 53
München
D-80687
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC4-05154-173-DEU

Study information

Scientific title

IMPLICOR®-NOW: IMPLICOR® Non-interventional, Observational study With metoprolol/ivabradine fixed combination

Acronym

IMPLICOR®-NOW

Study hypothesis

The aim of this non-interventional study (NIS) is to analyze application, effectiveness and tolerability of fixed combination IMPLICOR® (Metoprolol/Ivabradine) in symptomatic patients with angina pectoris over a 4-month treatment under daily practice conditions.

Ethics approval

Freiburg ethics commission international, 28/09/2015, ref: 015/1560

Study design

Multi-centre prospective non-interventional study

Primary study design

Observational

Secondary study design

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Angina pectoris

Intervention

Participants with chronic stable angina pectoris who are being treated with IMPLICOR® according to physicians assessment and the Summary of Product Characteristic (recommended dose: twice a day one tablet, one in the morning and one at night) are informed about the study and written consent for participation is obtained. Treatment is observed and data are documented over a period of 4 months. At baseline (U1) physician documents data about anamnesis and treatment with IMPLICOR®. Patient questionnaire regarding compliance is handed out and filled out by patient. About 1 month after baseline (U2), patients attend a further appointment and changes of concomitant medication, information on chronic stable angina pectoris and treatment with IMPLICOR® are documented. If applicable, adverse events and safety information are recorded. A final examination (U3) should take place about four months after baseline. At this appointment changes of concomitant medication, information on chronic stable angina pectoris, treatment with IMPLICOR® and adverse events and safety information are documented. IMPLICOR® therapy is assessed by physician and patient questionnaire regarding compliance is handed out and filled out by patient.

Intervention type

Phase

Drug names

Primary outcome measures

1. Influence of IMPLICOR® therapy on heart rate at each visit measured at baseline, 1 month and 4 months
2. Influence of IMPLICOR® therapy on number of angina attacks at each visit measured at baseline, 1 month and 4 months

Secondary outcome measures

1. Influence of IMPLICOR® therapy on use of short-acting nitrates measured at baseline, 1 month and 4 months
2. Influence of IMPLICOR® therapy on symptomatic classification (CCS-class) by physicians' assessment measured at baseline and 4 months
3. Influence of IMPLICOR® therapy on hospitalization rate measured at baseline and 4 months
4. Influence of IMPLICOR® therapy on patients’ compliance/adherence measured at baseline and 4 months
5. Adding of knowledge regarding general tolerance and specific adverse drug reactions (ADR) under IMPLICOR® therapy by standardized questionnaire measured at 1 month and 4 months
6. General assessment of IMPLICOR® therapy in symptomatic patients with angina pectoris by physician measured at 4 months

Overall trial start date

02/11/2015

Overall trial end date

31/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Ambulatory patients with chronic stable angina pectoris, who are treated according to the indication of IMPLICOR®.
3. Patients who were treated with free combination of active substances and who were controlled with equivalent doses of the free combination.
4. Patients with or without concomitant diseases

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1500

Participant exclusion criteria

1. Less than 18 years of age
2. Patients with contraindications to IMPLICOR®

Recruitment start date

02/11/2015

Recruitment end date

31/01/2016

Locations

Countries of recruitment

Germany

Trial participating centre

Heart Center of the University of Rostock (Herzzentrum der Universität Rostock)
Schillingallee 35
Rostock
18057
Germany

Sponsor information

Organisation

Servier Deutschland GmbH

Sponsor details

Elsenheimerstr. 53
München
D-80687
Germany
089/57095-01
info@de.netgrs.com

Sponsor type

Industry

Website

http://www.servier.de/

Funders

Funder type

Not defined

Funder name

Servier Deutschland GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Statistical analysis and preparation of an integrated final report takes place after completion of data collection. It is planned to publish the core results of the study.

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes