Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298045
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-03-01
Brief Title:
Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy
Sponsor:
Servier Affaires Médicales
Organization:
Servier
Study Overview
Official Title:
Effectiveness and Impact on Quality of Life of a Combination of Trimetazidine With One Hemodynamic Agent ß-blocker or Ca-channel Blocker in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy a Prospective International Non-interventional Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy the effect of a combination of this hemodynamic agent with a metabolic one trimetazidine The treatment effect will be measured by the reduction of patients angina symptoms physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items SAQ-7 Patients will be also proposed to complete a BEAMER BEhavioral and Adherence Model for improving quality health outcomes and cost-Effectiveness of healthcaRe questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative IMI Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None