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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02500290
• Other study ID #: FPS-AAS-2014-01
• Status: Active, not recruiting
• Start date: November 2014
• Est. completion date: March 2021

Study information

• Verified date: February 2019
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: March 2021
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Spain	Hospital de Jerez	Cádiz
Spain	Hospital de Puerto Real	Cádiz
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital de Antequera	Málaga
Spain	Hospital Regional de Málaga	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	type of antiplatelet were used	There are the following therapeutic groups: Clopidogrel; Prasugrel; Ticagrelor; Switching to Prasugrel ; Switching toTicagrelor	12 months
Secondary	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
Secondary	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