Clinical trial NCT02500290: Antiplatelet Therapy in Acute Coronary Syndrome(ACS). Safety and Efficacy of Switching Antiplatelet
Official title: Antiplatelet Therapy in Acute Coronary Syndrome (ACS). Safety and Efficacy of Switching Antiplatelet
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: ACS
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with acute coronary syndrome

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

Eligibility criteria: 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.

Primary outcomes:
measure: type of antiplatelet were used
timeFrame: 12 months
Secondary outcomes:
measure: ischemic events after ACS during hospitalization
timeFrame: 3, 6 and 12 months
measure: Total rate of hemorrhage and severity thereof under TIMI9 and BARC15 classification. Also it included as a safety endpoint all-cause mortality.
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Cádiz
country: Spain
facility: Hospital de Jerez
city: Cádiz
country: Spain
facility: Hospital de Puerto Real
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Málaga
country: Spain
facility: Hospital de Antequera
city: Málaga
country: Spain
facility: Hospital Regional de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Manuel Almedro Delia, MD
role: STUDY_DIRECTOR
References:
citation: 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.