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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500290
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud )

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.

Condition or disease
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

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antiplatelet Therapy in Acute Coronary Syndrome (ACS). Safety and Efficacy of Switching Antiplatelet
Study Start Date : November 2014
Actual Primary Completion Date : February 21, 2019
Estimated Study Completion Date : March 2021

Group/Cohort
Acute coronary syndrome



Primary Outcome Measures :
  1. type of antiplatelet were used [ Time Frame: 12 months ]

    There are the following therapeutic groups:

    Clopidogrel; Prasugrel; Ticagrelor; Switching to Prasugrel ; Switching toTicagrelor



Secondary Outcome Measures :
  1. ischemic events after ACS during hospitalization [ Time Frame: 3, 6 and 12 months ]

    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


  2. Total rate of hemorrhage and severity thereof under TIMI9 and BARC15 classification. Also it included as a safety endpoint all-cause mortality. [ Time Frame: 3, 6 and 12 months ]
    bleeding complications: BARC, TIMI classification, transfusions, major bleedingbleeding complications: BARC, TIMI classification, transfusions, major bleeding



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with acute coronary syndrome
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500290


Locations
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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, Spain
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
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Study Director: Manuel Almedro Delia, MD Hospital Universitario Virgen Macarena
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Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02500290    
Other Study ID Numbers: FPS-AAS-2014-01
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: February 2019
Keywords provided by Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud ):
ACS
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases