Antiplatelet Therapy in Acute Coronary Syndrome(ACS). Safety and Efficacy of Switching Antiplatelet

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT02500290
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

Brief Summary

This study aims to describe antiplatelet therapy in ACS in Andalusia and make an assessment of efficacy and safety of hospital use Prasugrel / ticagrelor vs. Clopidogrel and Prasugrel switching to / ticagrelor patients pretreated with clopidogrel.

Detailed Description

The management of acute coronary syndrome has changed in recent years as reflected in the new Clinical Practice Guidelines of the European Society of Cardiology for the management of ACS with or without ST segment elevation, with the development and increased accessibility of the angiography and percutaneous coronary intervention and the arrival of the new antiplatelet (Prasugrel and Ticagrelor).

The ACS encompasses several clinical entities where dual antiplatelet therapy remains the basis of antiplatelet therapy and one of the mainstays of treatment. But the emergence of Prasugrel and Ticagrelor have changed the classical management with aspirin plus clopidogre

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Status Verified: 2019-02
• Primary Completion: 2019-02-21
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-19
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patients admitted to the Coronary Care Unit at the time defined with an initial diagnosis of ACS.

Exclusion Criteria

• Myocarditis, Takotsubo syndrome, pulmonary thromboembolism.
• Secondary MI or type 2, caused by an increase in demand or decrease oxygen (anemia, tachycardia, hypotension, heart failure, etc.). 11
• Patients under 18 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
type of antiplatelet were used	12 months	There are the following therapeutic groups: Clopidogrel; Prasugrel; Ticagrelor; Switching to Prasugrel ; Switching toTicagrelor

Secondary Outcome Measures

Name	Time	Method
ischemic events after ACS during hospitalization	3, 6 and 12 months	Ischemic event is defined as the combined end point of stroke, reinfarction, stent thrombosis, restenosis and stent injury retreat previously treated; 1. thrombotic complications: stroke, stent restenosis, retreat of the culprit vessel, stent thrombosis, CVA
Total rate of hemorrhage and severity thereof under TIMI9 and BARC15 classification. Also it included as a safety endpoint all-cause mortality.	3, 6 and 12 months	bleeding complications: BARC, TIMI classification, transfusions, major bleedingbleeding complications: BARC, TIMI classification, transfusions, major bleeding

Trial Locations

Locations (8)

Hospital de Puerto Real; 🇪🇸 Cádiz, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Regional de Málaga; 🇪🇸 Málaga, Spain

Hospital de Jerez; 🇪🇸 Cádiz, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital de Antequera; 🇪🇸 Málaga, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain