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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Spain
  • Cádiz, Spain
    • Hospital de Puerto Real
  • Cádiz, Spain
    • Hospital de Jerez
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
  • Granada, Spain
    • Hospital Universitario Virgen de las Nieves
  • Málaga, Spain
    • Hospital Universitario Virgen de la Victoria
  • Málaga, Spain
    • Hospital de Antequera
  • Málaga, Spain
    • Hospital Regional de Malaga
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with acute coronary syndrome

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Acute coronary syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
type of antiplatelet were used	There are the following therapeutic groups: Clopidogrel; Prasugrel; Ticagrelor; Switching to Prasugrel ; Switching toTicagrelor	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ischemic events after ACS during hospitalization	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	3, 6 and 12 months
Total rate of hemorrhage and severity thereof under TIMI9 and BARC15 classification. Also it included as a safety endpoint all-cause mortality.	bleeding complications: BARC, TIMI classification, transfusions, major bleedingbleeding complications: BARC, TIMI classification, transfusions, major bleeding	3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza Progreso y Salud
• Investigators: Study Director: Manuel Almedro Delia, MD, Hospital Universitario Virgen Macarena

Publications and helpful links

General Publications

• Almendro-Delia M, Blanco-Ponce E, Carmona-Carmona J, Arboleda Sanchez JA, Rodriguez Yanez JC, Soto Blanco JM, Fernandez Garcia I, Castillo Caballero JM, Garcia-Rubira JC, Hidalgo-Urbano RJ. Comparative Safety and Effectiveness of Ticagrelor versus Clopidogrel in Patients With Acute Coronary Syndrome: An On-Treatment Analysis From a Multicenter Registry. Front Cardiovasc Med. 2022 May 27;9:887748. doi: 10.3389/fcvm.2022.887748. eCollection 2022.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): February 21, 2019
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: ACS
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: FPS-AAS-2014-01