Clinical trial NCT04630288: Safety and Efficacy of Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndrome
Official title: ANTIPLATELET TREATMENT IN ACUTE CORONARY SYNDROMES. SAFETY AND EFFICACY OF ANTIPLATELET SWITCHING Safety and Efficacy of Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndromes
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ACS in a real world setting

Brief summary: Multicenter post-approval observational retrospective cohort study in routine clinical practice (Real World Evidence Study) to assess the 1-year safety profile associated with ticagrelor and clopidogrel therapy in a contemporary reprospective cohort of patients who survived the initial 30-day period after the index hospitalization for acute coronary syndrome (ACS).

Detailed description: To date, there are still a paucity of data on the medium- and long-term safety and efficacy outcomes of new antiplatelet agents, namely Ticagrelor and Prasugrel, compared to Clopidogrel in a real-world ACS setting.

The ARIAM-Andalusia multicentre Registry, and the CREA-ARIAM multicentre Registry (ClinicalTrials.gov Identifier: NCT02500290; Fundación Pública Andaluza Progreso y SaludIdentifier: FPS-AAS-2014-01), are two Real World Evidence (RWE) studies aimed to investigate real-world practice on antiplatelet treatment in patients with ACS in Andalusia (Western Spain).

Our group are interested in performing a retrospective observational pilot analysis using data from patients with ACS admitted to cardiovascular intensive care units in Andalusia (Spain), who were prospectively included in the ARIAM-Andalusia multicentre Registry, and the CREA-ARIAM multicentre Registry (ClinicalTrials.gov Identifier: NCT02500290; Fundación Pública Andaluza Progreso y Salud-Identifier: FPS-AAS-2014-01) between 2014 and March 2019. The main findings from the RWE study revealed a consistent net clinical benefit of Ticagrelor vs Clopidogrel resulted in a significant reduction of short-term all-cause mortality favored Ticagrelor. In this scenario, after baseline imbalance adjustment using propensity score matching (PSM) and IPTW (inverse probability of treatment weight) methods, the net clinical benefit with Ticagrelor persisted. Preliminary results of the above mentioned study have been presented as an oral communication at the Annual Scientific Meeting of the Spanish Society of Cardiology (Madrid, October 2017).

The aim of this new pilot study suggested is to describe the efficacy and safety of Ticagrelor vs Clopidogrel after the first 30 days from hospital discharge and up to 1 year follow-up.

Eligibility criteria: Inclusion Criteria:

All-comers ACS population (with or without ST segment elevation, including unstable angina) with:

A recent CCU admission (patients included in the ARIAM-CREA study within 1 week from the index ACS admission between March 1, 2015 to March 31, 2018), irrespective of either the initial management (invasive or non-invasive) or the revascularization procedure (PCI with stenting or CABG) discharged on DAPT including either Ticagrelor or Clopidogrel and have survived the first 30-day follow-up period from the index ACS event and could complete a 12-month follow-up.

Exclusion Criteria:

* Age \< 18 years.
* Subjects who died in the first 30-day follow-up period from the index ACS event, including those who died during the index admission.
* A medical condition likely to limit survival to less than 1 year.
* Any factors judged by the local investigators to be likely to limit adherence to pharmacological treatment.
* Failure to obtain informed consent from participant.
* Currently enrolled in an interventional clinical research trial involving an investigational product (drug) or device
* Not available for follow-up over a minimum of 365 days, e.g. no fixed home address.
* Pregnancy, breast-feeding, or intend to become pregnant during the study period population should be always considered as exclusion criterion.
* Non-ACS diagnosis at discharge, i.e., acute myocarditis, Takotsubo syndrome, pulmonary thromboembolism or acute aortic syndromes.
* Myocardial infarction secondary to an ischaemic imbalance or type 2 myocardial infarction (Third Universal Definition of MI), in instances of myocardial injury with necrosis, where a condition other than CAD contributes to an imbalance between myocardial oxygen supply and/or demand, i.e., anaemia, sepsis, tachyarrhythmias, hypotension, heart failure...
* Patients not discharged on dual antiplatelet therapy (DAPT) consistent on low dose of ASA plus a P2Y12platelet receptor inhibitor (Clopidogrel or Ticagrelor)
* Patient discharged on DAPT including Prasugrel as the P2Y12 inhibitor drug.
* Hypersensitivity to ticagrelor or any of the excipients.
* Active pathological bleeding.
* History of intracranial haemorrhage (ICH).
* Severe hepatic impairment.

Primary outcomes:
measure: Major bleeding
timeFrame: During 2 months
Secondary outcomes:
measure: Thrombolysis in Myocardial Infarction (TIMI)
timeFrame: During 2 months
measure: BARC definition
timeFrame: During 2 months
measure: Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: During 2 months
measure: All-cause mortality
timeFrame: During 2 months
measure: Myocardial infarction
timeFrame: During 2 months
measure: Target lesion revascularization
timeFrame: During 2 months
measure: Stent thrombosis
timeFrame: During 2 months
measure: Stroke
timeFrame: During 2 months
measure: Net clinical benefit/Net Adverse Clinical Event (NACE):
timeFrame: During 2 months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Fundación Pública Progreso y Salud
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
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.