NCT04630288

Safety and Efficacy of Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndrome

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
• Phase: —
• Study type: Observational
• Enrollment: 1,900 (actual)
• Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (ClinicalTrials.gov 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 (ClinicalTrials.gov 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.

Conditions

• Acute Coronary Syndromes

Interventions

Type	Name	Description
DRUG	Clopidogrel	Describe the safety of Ticagrelor vs Clopidogrel use, in patients with ACS in terms of major bleeding between 30 days and one year after the index ACS event. An ITT approach and IPCW method to adjust for change of initial treatment will be used for the analysis.
DRUG	Ticagrelor	Describe the safety of Ticagrelor vs Clopidogrel use, in patients with ACS in terms of major bleeding between 30 days and one year after the index ACS event. An ITT approach and IPCW method to adjust for change of initial treatment will be used for the analysis.

Timeline

• Start date: 2019-07-02
• Primary completion: 2019-11-01
• Completion: 2020-12-31
• First posted: 2020-11-16
• Last updated: 2020-11-16

Locations

2 sites across 1 country: Spain