Acute Coronary SyndromeNCT02500290
Antiplatelet Therapy in Acute Coronary Syndrome(ACS). Safety and Efficacy of Switching Antiplatelet
An observational study of Acute Coronary Syndrome, run by Fundación Pública Andaluza Progreso y Salud at 8 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 2,000 participants
- Where
- 8 sitesSpain
- Study dates
- Nov 2014to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with acute coronary syndrome
Who may be able to join
- Patients admitted to the Coronary Care Unit at the time defined with an initial diagnosis of ACS.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital de Jerez
Cadiz
Hospital de Puerto Real
Cadiz
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitario Virgen de las Nieves
Granada
Hospital de Antequera
Málaga
Hospital Regional de Málaga
Málaga
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Universitario Virgen Macarena
Seville
About this study
Official title: Antiplatelet Therapy in Acute Coronary Syndrome (ACS). Safety and Efficacy of Switching Antiplatelet
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
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute coronary syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
type of antiplatelet were used
There are the following therapeutic groups:
Clopidogrel; Prasugrel; Ticagrelor; Switching to Prasugrel ; Switching toTicagrelor
Measured: 12 months
Secondary outcomes (2)
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
- thrombotic complications: stroke, stent restenosis, retreat of the culprit vessel, stent thrombosis, CVA
Measured: 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.
bleeding complications: BARC, TIMI classification, transfusions, major bleedingbleeding complications: BARC, TIMI classification, transfusions, major bleeding
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startNov 2014
- Primary completion21 Feb 2019
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Almedro Delia, MD, Study director, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500290
- Sponsor's protocol ID
- FPS-AAS-2014-01
- Status last verified
- Feb 2019
- First submitted
- 7 Jul 2015
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37573968Almendro-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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelet Therapy in Acute Coronary Syndrome (ACS). Safety and Efficacy of Switching Antiplatelet
- ClinicalTrials.gov ID
- NCT02500290
- Acronym / sponsor ID
- FPS-AAS-2014-01
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute coronary syndrome | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with acute coronary syndrome
Key inclusion criteria (1 listed)
- Patients admitted to the Coronary Care Unit at the time defined with an initial diagnosis of ACS.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
type of antiplatelet were used
Time frame: 12 months
There are the following therapeutic groups: Clopidogrel; Prasugrel; Ticagrelor; Switching to Prasugrel ; Switching toTicagrelor
2 secondary outcomes
ischemic events after ACS during hospitalization
Time frame: 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.
Time frame: 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Derived from this study: PubMed 37573968Almendro-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.
- Derived from this study: PubMed 35711382Almendro-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Almedro Delia, MD study director
Hospital Universitario Virgen Macarena
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Fundación Pública Andaluza Progreso y Salud at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
type of antiplatelet were used (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02500290, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.