Acute Coronary Syndrome Clinical Trial
Official title:
Evaluation of an Electronic Device Based Support Tool for ACS Patients: Brilique (Ticagrelor) Treatment Adherence (eMocial)
An electronic device application (APP) "Mein Herz und ich" has been developed specifically for acute coronary syndrome (ACS) patients who are prescribed to Brilique (ticagrelor) to increase adherence to treatment (medication and lifestyle changes) by a combination of reminders on medication intake, information on the importance of treatment, motivation by supportive messages, and visualisation of individual lifestyle choices' effect on cardiovascular risk. The aim of this study is to evaluate the effectiveness of this patient support tool
The target population are patients hospitalised with acute coronary syndrome (ACS) 18 years
or older with access to an electronic device (compatible with the patient support tool),
diagnosed with ST elevation myocardial infarction (STEMI), non-ST elevation myocardial
infarction (NSTEMI), unstable angina pectoris (UA) and treated with twice daily Brilique
(ticagrelor) co administered with low dose acetylsalicylic acid (ASA) according to the
prescription recommendation, within 14 days following the diagnosis of the ACS event.
Patients will be randomised 1:1 into an active group receiving the patient support tool under
investigation via electronic device application (APP) and a control group without patient
support tool. In addition, both active and control group will be randomised 1:1 to a group
with or without use of a Medical Event Monitoring System (MEMS) for evaluation of treatment
adherence. Patient questionnaires for evaluation of lifestyle changes, and quality of life
will be administered at the beginning (Visit 1) and end (Visit 2) of the observation period.
In addition, questionnaires for adherence, treatment attitudes, health care utilization and
risk factors will be administered in monthly intervals
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06013813 -
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI
|
N/A | |
| Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
| Recruiting |
NCT05412927 -
AngelMed Guardian® System PMA Post Approval Study
|
||
| Completed |
NCT02750579 -
Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?
|
N/A | |
| Completed |
NCT04102410 -
Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients
|
N/A | |
| Enrolling by invitation |
NCT03342131 -
Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome
|
N/A | |
| Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
| Enrolling by invitation |
NCT04676100 -
International CR Registry
|
||
| Completed |
NCT03590535 -
5th Generation cTnT in ED ACS
|
||
| Recruiting |
NCT05437900 -
INSIGHTFUL-FFR Clinical Trial
|
Phase 4 | |
| Completed |
NCT05551429 -
Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
|
||
| Terminated |
NCT04316481 -
IDE-ALERTS Continued Access Study
|
N/A | |
| Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
| Not yet recruiting |
NCT04852146 -
Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
|
||
| Active, not recruiting |
NCT02892903 -
In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes?
|
N/A | |
| Completed |
NCT02944123 -
Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)
|
Phase 3 | |
| Completed |
NCT04077229 -
Piloting Text Messages to Promote Positive Affect and Physical Activity
|
N/A | |
| Not yet recruiting |
NCT02871622 -
BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
|
N/A | |
| Active, not recruiting |
NCT02922140 -
The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit
|
N/A | |
| Completed |
NCT02673437 -
Rivaroxaban ACS Specialist Cohort Event Monitoring Study
|