Safety and Efficacy of Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndrome

Acute Coronary Syndromes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04630288
• Other study ID #: FPS-AAS-2019-01 (ESR-17-13127)
• Status: Active, not recruiting
• Start date: July 2, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2020
• Source: Andalusian Network for Design and Translation of Advanced Therapies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1900
• Est. completion date: December 31, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Syndrome

Intervention

Drug:
• Clopidogrel
Describe the safety of Ticagrelor vs Clopidogrel use, in patients with ACS in terms of major bleeding between 30 days and one year after the index ACS event. An ITT approach and IPCW method to adjust for change of initial treatment will be used for the analysis.
• Ticagrelor
Describe the safety of Ticagrelor vs Clopidogrel use, in patients with ACS in terms of major bleeding between 30 days and one year after the index ACS event. An ITT approach and IPCW method to adjust for change of initial treatment will be used for the analysis.

Locations

Country	Name	City	State
Spain	Fundación Pública Progreso y Salud	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding	Defined as BARC type= 3 according to the Bleeding Academic Research Consortium (BARC) definition at 1-year follow-up after the index ACS.	During 2 months
Secondary	Thrombolysis in Myocardial Infarction (TIMI)	Bleeding criteria	During 2 months
Secondary	BARC definition	Bleeding criteria	During 2 months
Secondary	Major Adverse Cardiac and Cerebrovascular Events (MACCE)	Defined as the composite of all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis and stroke or TIA at 1-year follow-up after the index ACS admission.	During 2 months
Secondary	All-cause mortality	Component of MACCE	During 2 months
Secondary	Myocardial infarction	Component of MACCE	During 2 months
Secondary	Target lesion revascularization	Component of MACCE	During 2 months
Secondary	Stent thrombosis	Component of MACCE	During 2 months
Secondary	Stroke	Component of MACCE	During 2 months
Secondary	Net clinical benefit/Net Adverse Clinical Event (NACE):	Defined as the composite of the efficacy (Major Adverse Cardiac and Cerebrovascular Events-MACCE) and safety (BARC type= 2 bleeding episodes according to the Bleeding Academic Research Consortium (BARC) definition for bleeding) outcomes at 1 year after the index ACS.	During 2 months