Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
677 participants
OBSERVATIONAL
2016-02-11
2019-03-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Use of Mobile-phone Based Patient Support in Patients Diagnosed With Myocardial Infarction
NCT01874262
Myocardial Infarction, COmbined-device, Recovery Enhancement Study
NCT03760796
Wearable Devices Faciliate the Management of AMI Patients
NCT06995495
Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias
NCT05298553
Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
NCT05326828
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a randomised investigation according to paragraph 23b of the German Medical Device Law examining the impact of the APP use on drug adherence, drug persistence and lifestyle changes in patients who have been prescribed Brilique (ticagrelor) as part of normal clinical practice in a 12 month timeframe after their ACS episode.
The device has a European Conformity Declaration (CE-mark). In this study no investigational product will be dispensed to the study participants. Patients will need to provide their own Brilique(ticagrelor) supply from the pharmacy, as in common clinical practice. Further, assessments in this study will not be used for guiding the treatment of the patients participating in the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active APP with MEMS
ACS patients 18 years or older with access to an electronic device (compatible with the patient support tool), diagnosed with STEMI, NSTEMI or UA treated with twice daily Brilique(ticagrelor) co administered with low dose acetylsalicylic acid according to the prescription recommendation using active APP with MEMS
Active group with MEMS
Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool and with MEMS
Active APP without MEMs
ACS patients 18 years or older with access to an electronic device (compatible with the patient support tool), diagnosed with STEMI, NSTEMI or UA treated with twice daily Brilique(ticagrelor) co administered with low dose acetylsalicylic acid according to the prescription recommendation using active APP without MEMS
Active group without MEMS
Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool but without MEMS
Control APP with MEMS
ACS patients 18 years or older with access to an electronic device (compatible with the patient support tool), diagnosed with STEMI, NSTEMI or UA treated with twice daily Brilique(ticagrelor) co administered with low dose acetylsalicylic acid according to the prescription recommendation using control APP with MEMS
Control group with MEMS
Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool but with MEMS
Control APP without MEMS
ACS patients 18 years or older with access to an electronic device (compatible with the patient support tool), diagnosed with STEMI, NSTEMI or UA treated with twice daily Brilique(ticagrelor) co administered with low dose acetylsalicylic acid according to the prescription recommendation using control APP without MEMS
Control group without MEMS
Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool and without MEMS
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active group with MEMS
Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool and with MEMS
Active group without MEMS
Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool but without MEMS
Control group with MEMS
Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool but with MEMS
Control group without MEMS
Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool and without MEMS
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female or male aged 18 years or older
* Acute Coronary Syndrome patients, diagnosed with ST elevation myocardial infarction, non-ST elevation myocardial infarction or unstable angina pectoris treated with Brilique (ticagrelor) prior to inclusion into this study and for whom the treating physician intends to continue prescribing twice daily Brilique (ticagrelor) co administered with low dose acetylsalicylic acid according to the prescription recommendation, within 14 days following the diagnosis of the ACS event
* Ability to read, understand and write German
* Patients must have access to an electronic device (compatible with the patient support tool) and willing to use it on a daily basis
Exclusion Criteria
* Participation in another clinical study with an investigational product or medical device during the last 30 days, excluding prospective/retrospective register based studies that do not require any extra visits in addition to ordinary health care
* Patients on treatment with Oral Anti-Platelet drugs other than Brilique (ticagrelor)
* Patients with contraindication to the use of Brilique (ticagrelor)
* Patients accepted/with a plan for thoracic surgery (coronary artery bypass grafting, CABG) or any other elective surgery that cannot be postponed until after study participation
* Presence of serious/severe co-morbidities in the opinion of the Investigator which may limit life expectancy (\<1 year)
* For women only: patients who are currently pregnant (confirmed with positive pregnancy test) or breast feeding
18 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Florian Krackhardt, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Bad Berka, , Germany
Research Site
Bad Bevensen, , Germany
Research Site
Bad Krozingen, , Germany
Research Site
Barby, , Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Bernau, , Germany
Research Site
Chemnitz, , Germany
Research Site
Coburg, , Germany
Research Site
Düsseldorf, , Germany
Research Site
Erkrath, , Germany
Research Site
Essen, , Germany
Research Site
Frankfurt, , Germany
Research Site
Gelsenkirchen, , Germany
Research Site
Hamburg, , Germany
Research Site
Heidelberg, , Germany
Research Site
Kassel, , Germany
Research Site
Kassel, , Germany
Research Site
Kiel, , Germany
Research Site
Kleve, , Germany
Research Site
Lübeck, , Germany
Research Site
Mainz, , Germany
Research Site
Mönchengladbach, , Germany
Research Site
Münster, , Germany
Research Site
Oldenburg, , Germany
Research Site
Regensburg, , Germany
Research Site
Rostock, , Germany
Research Site
Rotenburg (Wümme), , Germany
Research Site
Siegen, , Germany
Research Site
Tegel, , Germany
Research Site
Wuppertal, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Krackhardt F, Jornten-Karlsson M, Waliszewski M, Knutsson M, Niklasson A, Appel KF, Degenhardt R, Ghanem A, Kohler T, Ohlow MA, Tschope C, Theres H, Vom Dahl J, Karlson BW, Maier LS. Results from the "Me & My Heart" (eMocial) Study: a Randomized Evaluation of a New Smartphone-Based Support Tool to Increase Therapy Adherence of Patients with Acute Coronary Syndrome. Cardiovasc Drugs Ther. 2023 Aug;37(4):729-741. doi: 10.1007/s10557-022-07331-1. Epub 2022 Apr 20.
Krackhardt F, Maier LS, Appel KF, Kohler T, Ghanem A, Tschoepe C, Dahl JV, Degenhardt R, Niklasson A, Ahlqvist M, Waliszewski MW, Jornten-Karlsson M. Design and rationale for the "Me & My Heart" (eMocial) study: A randomized evaluation of a new smartphone-based support tool to increase therapy adherence of patients with acute coronary syndrome. Clin Cardiol. 2019 Nov;42(11):1054-1062. doi: 10.1002/clc.23254. Epub 2019 Sep 6.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D5130C00161
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.