NCT02500290

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

June 19, 2019

Status Verified

February 1, 2019

Enrollment Period

4.3 years

First QC Date

July 7, 2015

Last Update Submit

June 18, 2019

Conditions

Acute Coronary Syndrome

Keywords

ACS

Outcome Measures

Primary Outcomes (1)

  • type of antiplatelet were used

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

    12 months

Secondary Outcomes (2)

  • ischemic events after ACS during hospitalization

    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.

    3, 6 and 12 months

Study Arms (1)

Acute coronary syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with acute coronary syndrome

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital de Jerez

Cadiz, Spain

Location

Hospital de Puerto Real

Cadiz, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Hospital de Antequera

Málaga, Spain

Location

Hospital Regional de Málaga

Málaga, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Related Publications (2)

  • Almendro-Delia M, Padilla-Rodriguez G, Hernandez-Meneses B, Blanco-Ponce E, Arboleda-Sanchez JA, Rodriguez-Yanez JC, Soto-Blanco JM, Fernandez-Garcia I, Castillo-Caballero JM, Garcia-Rubira JC, Hidalgo-Urbano R. Nonadherence to ticagrelor versus clopidogrel and clinical outcomes in patients with ACS. Results from the CREA-ARIAM registry. Rev Esp Cardiol (Engl Ed). 2024 Feb;77(2):113-124. doi: 10.1016/j.rec.2023.05.011. Epub 2023 Sep 29. English, Spanish.

    PMID: 37573968DERIVED

  • 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.

    PMID: 35711382DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Manuel Almedro Delia, MD

    Hospital Universitario Virgen Macarena

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 16, 2015

Study Start

November 1, 2014

Primary Completion

February 21, 2019

Study Completion

March 1, 2021

Last Updated

June 19, 2019

Record last verified: 2019-02

Locations

ES(8)