An observational study looking at the effects of treating angina pectoris with IMPLICOR® (Metoprolol/ivabradine)
| ISRCTN | ISRCTN51906157 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51906157 |
| Secondary identifying numbers | IC4-05154-173-DEU |
- Submission date
- 19/10/2015
- Registration date
- 28/10/2015
- Last edited
- 15/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Servier Deutschland GmbH
Elsenheimerstr. 53
München
D-80687
Germany
Study information
| Study design | Multi-centre prospective non-interventional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | IMPLICOR®-NOW: IMPLICOR® Non-interventional, Observational study With metoprolol/ivabradine fixed combination |
| Study acronym | IMPLICOR®-NOW |
| Study objectives | 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(s) | Freiburg ethics commission international, 28/09/2015, ref: 015/1560 |
| Health condition(s) or problem(s) studied | 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Metoprolol, ivabradine |
| Primary outcome measure | 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 study start date | 01/06/2015 |
| Completion date | 30/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1500 |
| Total final enrolment | 747 |
| Key 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 |
| Key exclusion criteria | 1. Less than 18 years of age 2. Patients with contraindications to IMPLICOR® |
| Date of first enrolment | 02/11/2015 |
| Date of final enrolment | 31/01/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
Rostock
18057
Germany
Sponsor information
Industry
Elsenheimerstr. 53
München
D-80687
Germany
| Phone | 089/57095-01 |
|---|---|
| info-de@servier.com | |
| Website | http://www.servier.de/ |
"ROR" |
https://ror.org/05wk4ae67 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Georg Stöckl (georg.stoeckl@servier.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 01/08/2017 | 16/10/2017 | No | No | |
| Results article | results | 01/12/2017 | Yes | No | |
| Results article | results | 01/12/2019 | 15/08/2019 | Yes | No |
Additional files
- ISRCTN51906157_BasicResults_01Aug17.pdf
- Uploaded 16/10/2017
Editorial Notes
15/08/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
09/11/2017: Publication reference added.
11/08/2017: Sponsor email changed from info@de.netgrs.com to info-de@servier.com. The overall trial start date has been changed from 02/11/2015 to 01/06/2015.
08/05/2017: The overall trial end date has been updated from 31/05/2016 to 30/09/2016.
