Ignite Creation Date:
2024-05-06 @ 12:53 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01689493
Status:
COMPLETED
Last Update Posted:
2012-09-21
First Post:
2012-08-16
Brief Title:
Strategy to Improve Antiplatelet Therapy Adherence After Coronary Stent Implantation
Sponsor:
Hôpital de la Timone
Organization:
Hôpital de la Timone
Study Overview
Official Title:
Strategy to Improve Antiplatelet Therapy Adherence After Coronary Stent Implantation
Status:
COMPLETED
Status Verified Date:
2012-09
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 the effectiveness of an adherence protocol intervention among stented patients to improve adherence to antiplatelet therapy primary endpoint Secondary endpoints will assess whether the intervention reduces cardiovascular events ACS stent thrombosis re- hospitalization and coronary angiography revascularization all-cause mortality and its cost-effectiveness
Detailed Description:
RATIONALE Acute coronary syndrome is the first cause of mortality in cardiology Development of stent and dual antiplatelet therapy have led to important declines in morbi-mortality Despite this the risk of recurrent events and mortality after stent implantation remains substantial especially within the first six months Non-adherence to antiplatelet therapy is the major modifiable risk factor that expose to adverse outcomes following stent implantation and has been identified as the major risk factor of stent thrombosis Prior interventions to improve medication adherence in cardiovascular populations have produced mixed results and have not specifically assessed compliance to antiplatelet therapy in patients treated by stent implantation after acute coronary syndrome
It is currently unknown if interventions to improve antiplatelet therapy compliance in the six month after stenting discharge will improve medication adherence and clinical outcomes or will be cost-effective
OBJECTIVES investigators propose to assess the effectiveness of a multi-faceted patient-centered adherence intervention among patients following stent implantation to improve adherence to antiplatelet therapy primary aim
Secondary aims will assess whether the intervention improve
1 Cardiovascular events ACS stent thrombosis re - hospitalization and coronary angiography new revascularization all-cause mortality
2 Cost-effectiveness
METHOD Investigators propose a six month mono-site patient-level randomized controlled trial to evaluate relative to usual care a multi-faceted patient-centered intervention to improve adherence to antiplatelet treatment among stented patients following ACS The study will enroll 800 patients to intervention versus usual care for 6 months in one university hospital CHU Timone Marseille France The proposed intervention will be based on several conceptual frameworks Chronic Care Model and Medication Adherence Model and adapt elements of prior successfully adherence interventions including collaborative care patient education tailoring of medication regimens and daily mobile phone short message service SMS The primary analyses will be a comparison of adherence to antiplatelet therapy using specific laboratory testing of drug effect Secondary analyses will compare incidence of clinical endpoints in both groups cost-effectiveness analysis will be performed All analyses will be intention to treat
It is currently unknown if interventions to improve antiplatelet therapy compliance in the six month after stenting discharge will improve medication adherence and clinical outcomes or will be cost-effective
OBJECTIVES investigators propose to assess the effectiveness of a multi-faceted patient-centered adherence intervention among patients following stent implantation to improve adherence to antiplatelet therapy primary aim
Secondary aims will assess whether the intervention improve
1 Cardiovascular events ACS stent thrombosis re - hospitalization and coronary angiography new revascularization all-cause mortality
2 Cost-effectiveness
METHOD Investigators propose a six month mono-site patient-level randomized controlled trial to evaluate relative to usual care a multi-faceted patient-centered intervention to improve adherence to antiplatelet treatment among stented patients following ACS The study will enroll 800 patients to intervention versus usual care for 6 months in one university hospital CHU Timone Marseille France The proposed intervention will be based on several conceptual frameworks Chronic Care Model and Medication Adherence Model and adapt elements of prior successfully adherence interventions including collaborative care patient education tailoring of medication regimens and daily mobile phone short message service SMS The primary analyses will be a comparison of adherence to antiplatelet therapy using specific laboratory testing of drug effect Secondary analyses will compare incidence of clinical endpoints in both groups cost-effectiveness analysis will be performed All analyses will be intention to treat
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None