CClinicalTrials.gg
Status unknownNCT02500290Updated Jun 19, 2019

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

An observational study in Acute Coronary Syndrome, sponsored by Fundación Pública Andaluza Progreso y Salud. Status unknown at 8 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-19.

Sponsored by Fundación Pública Andaluza Progreso y Salud · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Acute Coronary Syndrome

Keywords

  • ACS
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In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Fundación Pública Andaluza Progreso y Salud is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with acute coronary syndrome

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acute coronary syndrome
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What researchers measure

Primary outcomes

  1. type of antiplatelet were used

    There are the following therapeutic groups: Clopidogrel; Prasugrel; Ticagrelor; Switching to Prasugrel ; Switching toTicagrelor

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 3, 6 and 12 months

  2. 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

    Time frame: 3, 6 and 12 months

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Study locations

8 sites
  • 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, Spain
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References and documents

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. PubMed 35711382 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02500290
Lead sponsor
Fundación Pública Andaluza Progreso y Salud
Responsible party
Sponsor
First posted
Jul 16, 2015
Start date
Nov 2014
Primary completion
Feb 21, 2019
Completion
Mar 2021 (estimated)
Last update
Jun 19, 2019

Study contacts

Manuel Almedro Delia, MD
study director · Hospital Universitario Virgen Macarena

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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