Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04630288
Status:
UNKNOWN
Last Update Posted:
2020-11-16
First Post:
2020-01-14
Brief Title:
Safety and Efficacy of Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndrome
Sponsor:
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Organization:
Andalusian Network for Design and Translation of Advanced Therapies
Study Overview
Official Title:
ANTIPLATELET TREATMENT IN ACUTE CORONARY SYNDROMES SAFETY AND EFFICACY OF ANTIPLATELET SWITCHING Safety and Efficacy of Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Multicenter post-approval observational retrospective cohort study in routine clinical practice Real World Evidence Study to assess the 1-year safety profile associated with ticagrelor and clopidogrel therapy in a contemporary reprospective cohort of patients who survived the initial 30-day period after the index hospitalization for acute coronary syndrome ACS
Detailed Description:
To date there are still a paucity of data on the medium- and long-term safety and efficacy outcomes of new antiplatelet agents namely Ticagrelor and Prasugrel compared to Clopidogrel in a real-world ACS setting
The ARIAM-Andalusia multicentre Registry and the CREA-ARIAM multicentre Registry ClinicalTrialsgov Identifier NCT02500290 Fundación Pública Andaluza Progreso y SaludIdentifier FPS-AAS-2014-01 are two Real World Evidence RWE studies aimed to investigate real-world practice on antiplatelet treatment in patients with ACS in Andalusia Western Spain
Our group are interested in performing a retrospective observational pilot analysis using data from patients with ACS admitted to cardiovascular intensive care units in Andalusia Spain who were prospectively included in the ARIAM-Andalusia multicentre Registry and the CREA-ARIAM multicentre Registry ClinicalTrialsgov Identifier NCT02500290 Fundación Pública Andaluza Progreso y Salud-Identifier FPS-AAS-2014-01 between 2014 and March 2019 The main findings from the RWE study revealed a consistent net clinical benefit of Ticagrelor vs Clopidogrel resulted in a significant reduction of short-term all-cause mortality favored Ticagrelor In this scenario after baseline imbalance adjustment using propensity score matching PSM and IPTW inverse probability of treatment weight methods the net clinical benefit with Ticagrelor persisted Preliminary results of the above mentioned study have been presented as an oral communication at the Annual Scientific Meeting of the Spanish Society of Cardiology Madrid October 2017
The aim of this new pilot study suggested is to describe the efficacy and safety of Ticagrelor vs Clopidogrel after the first 30 days from hospital discharge and up to 1 year follow-up
The ARIAM-Andalusia multicentre Registry and the CREA-ARIAM multicentre Registry ClinicalTrialsgov Identifier NCT02500290 Fundación Pública Andaluza Progreso y SaludIdentifier FPS-AAS-2014-01 are two Real World Evidence RWE studies aimed to investigate real-world practice on antiplatelet treatment in patients with ACS in Andalusia Western Spain
Our group are interested in performing a retrospective observational pilot analysis using data from patients with ACS admitted to cardiovascular intensive care units in Andalusia Spain who were prospectively included in the ARIAM-Andalusia multicentre Registry and the CREA-ARIAM multicentre Registry ClinicalTrialsgov Identifier NCT02500290 Fundación Pública Andaluza Progreso y Salud-Identifier FPS-AAS-2014-01 between 2014 and March 2019 The main findings from the RWE study revealed a consistent net clinical benefit of Ticagrelor vs Clopidogrel resulted in a significant reduction of short-term all-cause mortality favored Ticagrelor In this scenario after baseline imbalance adjustment using propensity score matching PSM and IPTW inverse probability of treatment weight methods the net clinical benefit with Ticagrelor persisted Preliminary results of the above mentioned study have been presented as an oral communication at the Annual Scientific Meeting of the Spanish Society of Cardiology Madrid October 2017
The aim of this new pilot study suggested is to describe the efficacy and safety of Ticagrelor vs Clopidogrel after the first 30 days from hospital discharge and up to 1 year follow-up
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