Acute Coronary SyndromesNCT04630288
Safety and Efficacy of Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndromes, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Clopidogrel and Ticagrelor
- How many people
- 1,900 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Jul 2019to 31 Dec 2020
- 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 with ACS in a real world setting
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fundación Pública Progreso y Salud
Seville, 41092
Hospital Universitario Virgen Macarena
Seville
About this study
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
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).
Read the 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.
- Conditions
- Acute Coronary Syndromes
- Being tested
- Clopidogrel, Ticagrelor
- 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.
ClopidogrelDrug
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.
TicagrelorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Clopidogrel is a prodrug that requires metabolic activation in two stepsby hepatic CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation. The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Consequently, due to the irreversible binding to the P2Y12 receptor,platelets exposed to clopidogrel's active metabolite are affected for the remainder of their lifespan (about 7 to 10 days) and recovery of normal platelet function occurs at a rate consistent with the normal platelet turnover. Clopidogrel was approved by the European Commission on 15 July 1998 for the secondary prevention of atherothrombotic events in adult patients with ACS. Receives: Drug: Clopidogrel | |
| Ticagrelor | Ticagrelor is a nucleoside analogue member of the chemical class cyclopentyltriazolopyrimidines (CPTP), which is a selective and reversible ADP- receptor antagonist acting on the platelet P2Y12 receptor. This prevents the binding of ADP to the receptor which attenuates plateletactivation and aggregation.The drug was approved by the European Commission on December 3, 2010, for the prevention of thrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with ACS (unstable angina, non ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]) including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 2 months
Secondary outcomes (9)
Thrombolysis in Myocardial Infarction (TIMI)
Bleeding criteria
Measured: During 2 months
BARC definition
Bleeding criteria
Measured: During 2 months
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.
Measured: During 2 months
All-cause mortality
Component of MACCE
Measured: During 2 months
Myocardial infarction
Component of MACCE
Measured: During 2 months
Target lesion revascularization
Component of MACCE
Measured: During 2 months
Stent thrombosis
Component of MACCE
Measured: During 2 months
Stroke
Component of MACCE
Measured: During 2 months
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.
Measured: During 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start2 Jul 2019
- Primary completion1 Nov 2019
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies 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
- Retrospective
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630288
- Sponsor's protocol ID
- FPS-AAS-2019-01 (ESR-17-13127)
- Status last verified
- Nov 2020
- First submitted
- 14 Jan 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35711382
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04630288
- Acronym / sponsor ID
- FPS-AAS-2019-01 (ESR-17-13127)
- Conditions
- Acute Coronary Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 16 Nov 2020 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | – | Drug: ClopidogrelClopidogrel is a prodrug that requires metabolic activation in two stepsby hepatic CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation. The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Consequently, due to the irreversible binding to the P2Y12 receptor,platelets exposed to clopidogrel's active metabolite are affected for the remainder of their lifespan (about 7 to 10 days) and recovery of normal platelet function occurs at a rate consistent with the normal platelet turnover. Clopidogrel was approved by the European Commission on 15 July 1998 for the secondary prevention of atherothrombotic events in adult patients with ACS. |
| Ticagrelor | – | Drug: TicagrelorTicagrelor is a nucleoside analogue member of the chemical class cyclopentyltriazolopyrimidines (CPTP), which is a selective and reversible ADP- receptor antagonist acting on the platelet P2Y12 receptor. This prevents the binding of ADP to the receptor which attenuates plateletactivation and aggregation.The drug was approved by the European Commission on December 3, 2010, for the prevention of thrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with ACS (unstable angina, non ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]) including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ACS in a real world setting
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelDescribe 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. | Drug | Clopidogrel |
| TicagrelorDescribe 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. | Drug | Ticagrelor |
Primary outcome
Major bleeding
Time frame: During 2 months
Defined as BARC type≥ 3 according to the Bleeding Academic Research Consortium (BARC) definition at 1-year follow-up after the index ACS.
9 secondary outcomes
Thrombolysis in Myocardial Infarction (TIMI)
Time frame: During 2 months
BARC definition
Time frame: During 2 months
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: During 2 months
All-cause mortality
Time frame: During 2 months
Myocardial infarction
Time frame: During 2 months
Target lesion revascularization
Time frame: During 2 months
Stent thrombosis
Time frame: During 2 months
Stroke
Time frame: During 2 months
Net clinical benefit/Net Adverse Clinical Event (NACE):
Time frame: During 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Syndromes, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 2 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 2 inclusion and 16 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 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Major bleeding (time frame: During 2 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 NCT04630288, which also lists 1 linked publication.
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 16 Nov 2020.