STEMIPhase 3ELECTRA-SIRIONCT04718025
Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome
A Phase 3 study testing Ticagrelor 90mg, Ticagrelor 60mg and Aspirin in people with STEMI and NSTEMI, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
Trial summary
The ELECTRA-SIRIO 2 study is a randomized, multicenter, double-blind, investigator-initiated clinical trial aimed to evaluate safety and efficacy of two ticagrelor-based de-escalation antiplatelet strategies in patients with acute coronary syndrome (ACS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI, NSTEMI, Unstable Angina
- What is being tested?
- Ticagrelor 90mg, Ticagrelor 60mg and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 1 sitePoland
- Study dates
- 7 Feb 2022to 30 Jun 2024
- Phase
- Phase 3
- 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
Who may be able to join
- diagnosis of STEMI or NSTEMI or unstable angina
- for patients with STEMI, the following three inclusion criteria will have to be met: 1) new ST-elevation at the J-point in two contiguous leads with the cut-point ≥1 mm in all leads other than leads V2-V3, where the following cut-points apply: ≥2mm in men ≥40 years; ≥2.5 mm in men <40 years, or ≥1.5 mm in women regardless of age; or a new left bundle-branch block 2) the intention to perform primary PCI 3) detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit
- for patients with NSTEMI or unstable angina, at least two of the following three criteria will have to be met:
- symptoms indicating myocardial ischaemia
- ST-segment changes on electrocardiography indicating myocardial ischaemia
- detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit in addition to at least one of the following:
Show all 15Show fewer
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- ≥60 years of age;
- previous MI or coronary artery by-pass grafting;
- ≥50% stenosis in ≥2 coronary arteries;
- previous ischaemic stroke or transient ischaemic attack;
- ≥50% carotid stenosis or cerebral revascularisation;
- diabetes mellitus;
- peripheral artery disease;
- chronic kidney disease with glomerular filtration rate <60 mL/min.
Who cannot join
- contraindications to ticagrelor or/and aspirin
- indications for oral anticoagulation therapy
- second or third grade atrio-ventricular block
- previous stent thrombosis on treatment with ticagrelor
- end stage kidney disease with glomerular filtration rate <15 mL/min or on haemodialysis
- administration of prasugrel during the index event
- pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Antoni Jurasz University Hospital No. 1
Bydgoszcz
Piotr Adamski, MD, PhD, +48 585 4023, piotr.adamski@cm.umk.pl
About this study
Official title: Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome: the Randomized, Multicenter, Double-blind ELECTRA RCT Study
The ELECTRA-SIRIO 2 study is a randomized, multicenter, double-blind, investigator-initiated clinical trial aimed to evaluate safety and efficacy of two ticagrelor-based de-escalation antiplatelet strategies in patients with acute coronary syndrome (ACS). During the hospitalization due to ACS, participants will be randomized in a 1:1:1 ratio into one of three arms: low-dose ticagrelor with aspirin (LDTA), low-dose ticagrelor with placebo (LDTP), and standard-dose ticagrelor with aspirin (SDTA), the latter being the control arm. Up to day 30, all enrolled patients will receive standard-dose ticagrelor (2x90mg) + aspirin (1x100mg). Starting from day 31 LDTA and LDTP patients will receive low-dose ticagrelor (2x60mg) + aspirin (1x100mg), SDTA - continuation of previous treatment. Starting from day 91 LDTP patients will receive low-dose ticagrelor (2x60mg) + placebo, SDTA and LDTA - continuation of previous treatment. The aim of the study is to evaluate the influence of ticagrelor maintenance dose reduction from 2x90mg to 2x60mg with or without continuation of aspirin versus dual antiplatelet therapy with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients.
- Conditions
- STEMI, NSTEMI, Unstable Angina
- Being tested
- Ticagrelor 90mg, Ticagrelor 60mg, Aspirin
- Keywords
- ticagrelor, aspirin, acute coronary syndrome
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90mgDrug
Also called Brilique
Up to day 30 after ACS, all enrolled patients will receive standard-dose ticagrelor 2x90mg as a part of dual antiplatelet therapy. Participants in SDTA arm will continue treatment with ticagrelor 2x90mg until 12 months post-ACS, while patients in LDTA and LDTP will be switched to low-dose ticagrelor 2x60 mg starting on day 31.
Ticagrelor 60mgDrug
Also called Brilique
Starting from day 31, LDTA and LDTP patients will receive low-dose ticagrelor 2x60mg until 12 months post-ACS.
AspirinDrug
Also called acetylsalicylic acid
Up to day 90 after ACS, all enrolled patients will receive aspirin 1x100mg as a part of dual antiplatelet therapy. Starting from day 91, LDTP patients will discontinue aspirin and proceed with low-dose ticagrelor monotherapy until 12 months post-ACS, while patients in LDTA and SDTA will continue aspirin 1x100 mg until 12 months post-ACS.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose ticagrelor with aspirin (LDTA) | Experimental | Patients with ACS in this arm will be subject to reduction of ticagrelor maintenance dose from 2x90mg to 2x60mg after the first month post-ACS, and will receive the following antiplatelet therapy:
1. ticagrelor 2x90mg + aspirin 1x100mg during the first 30 days after ACS;
2. ticagrelor 2x60mg + aspirin 1x100mg starting from day 31 until 12 months after ACS. Receives: Drug: Ticagrelor 60mg; Drug: Aspirin |
| Low-dose ticagrelor with placebo (LDTP) | Experimental | Patients with ACS in this arm will be subject to reduction of ticagrelor maintenance dose from 2x90mg to 2x60mg after the first month post-ACS, followed by discontinuation of aspirin after 3 months post-ACS, and will receive the following antiplatelet therapy:
1. ticagrelor 2x90mg + aspirin 1x100mg during the first 30 days after ACS;
2. ticagrelor 2x60mg + aspirin 1x100mg starting from day 31 until day 90 after ACS;
3. ticagrelor 2x60mg + placebo starting from day 91 until 12 months after ACS. Receives: Drug: Ticagrelor 60mg |
| Standard-dose ticagrelor with aspirin (SDTA) | Active comparator | Patients with ACS in this arm will receive standard dual antiplatelet therapy including ticagrelor 2x90mg + aspirin 1x100mg during the whole 12 months after ACS. Receives: Drug: Ticagrelor 90mg; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
BARC type 2, 3 or 5 bleeding
The primary safety composite end point of this study is the first occurrence of type 2, 3 or 5 bleeding according to the BARC criteria, occurring during the first 12 months after ACS.
Measured: 12 months after ACS
Death from any cause, nonfatal MI or nonfatal stroke.
The primary efficacy end point is the composite of death from any cause, first nonfatal MI, or first nonfatal stroke.
Measured: 12 months after ACS
Secondary outcomes (11)
Death from any cause, nonfatal MI, nonfatal stroke, BARC type 2, 3, or 5 bleeding.
The key secondary endpoint, net clinical effect, was defined as composite of death from any cause, nonfatal MI, or nonfatal stroke, and the first occurrence of BARC type 2, 3, or 5 bleeding.
Measured: 12 months after ACS
BARC type 3 or 5 bleeding
Composite of the first occurrence of type 3 or 5 bleeding according to the BARC criteria.
Measured: 12 months after ACS
TIMI major or minor bleeding
Composite of the first occurrence of major or minor bleeding according to the TIMI criteria.
Measured: 12 months after ACS
GUSTO moderate, severe, or life-threatening bleeding
Composite of the first occurrence of moderate, severe, or life-threatening bleeding according to the GUSTO criteria.
Measured: 12 months after ACS
ISTH major bleeding
The first occurrence of major bleeding according to the ISTH criteria.
Measured: 12 months after ACS
Death from any cause
Death from any cause.
Measured: 12 months after ACS
Death from cardiovascular causes
Death from cardiovascular causes.
Measured: 12 months after ACS
Myocardial infarction
Occurrence of myocardial infarction.
Measured: 12 months after ACS
Ischemic stroke
Occurrence of ischemic stroke.
Measured: 12 months after ACS
Definite or probable stent thrombosis
Occurrence of definite or probable stent thrombosis
Measured: 12 months after ACS
Dyspnea
Occurrence of dyspnea
Measured: 12 months after ACS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start7 Feb 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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 STEMIStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Principal investigator, Jacek Kubica, Collegium Medicum w Bydgoszczy
- Investigators
- Jacek Kubica, MD, PhD, Principal investigator, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, PolandEliano Navarese, MD, PhD, Principal investigator, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718025
- Sponsor's protocol ID
- 2019/ABM/01/00009
- Acronym
- ELECTRA-SIRIO
- Status last verified
- Apr 2023
- First submitted
- 17 Jan 2021
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kubica J, Adamski P, Niezgoda P, Kubica A, Podhajski P, Baranska M, Uminska JM, Pietrzykowski L, Ostrowska M, Siller-Matula JM, Badariene J, Bartus S, Budaj A, Dobrzycki S, Fidor L, Gasior M, Gessek J, Gierlotka M, Gil R, Goracy J, Grzelakowski P, Hajdukiewicz T, Jaguszewski M, Janion M, Kasprzak J, Kern A, Klecha A, Kleinrok A, Kochman W, Krakowiak B, Legutko J, Lesiak M, Nosal M, Piotrowski G, Przybylski A, Roleder T, Skonieczny G, Sobieszek G, Tycinska A, Wojciechowski D, Wojakowski W, Wojcik J, Zielinska M, Zurakowski A, Specchia G, Gorog DA, Navarese EP. A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study. Cardiol J. 2021;28(4):607-614. doi: 10.5603/CJ.a2021.0056. Epub 2021 Jun 7.
PubMed 34096012
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome: the Randomized, Multicenter, Double-blind ELECTRA RCT Study
- ClinicalTrials.gov ID
- NCT04718025
- Acronym / sponsor ID
- ELECTRA-SIRIO / 2019/ABM/01/00009
- Conditions
- STEMI, NSTEMI, Unstable Angina
- Keywords
- ticagrelor, aspirin, acute coronary syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Jan 2021 (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.
The ELECTRA-SIRIO 2 study is a randomized, multicenter, double-blind, investigator-initiated clinical trial aimed to evaluate safety and efficacy of two ticagrelor-based de-escalation antiplatelet strategies in patients with acute coronary syndrome (ACS). During the hospitalization due to ACS, participants will be randomized in a 1:1:1 ratio into one of three arms: low-dose ticagrelor with aspirin (LDTA), low-dose ticagrelor with placebo (LDTP), and standard-dose ticagrelor with aspirin (SDTA), the latter being the control arm. Up to day 30, all enrolled patients will receive standard-dose ticagrelor (2x90mg) + aspirin (1x100mg). Starting from day 31 LDTA and LDTP patients will receive low-dose ticagrelor (2x60mg) + aspirin (1x100mg), SDTA - continuation of previous treatment. Starting from day 91 LDTP patients will receive low-dose ticagrelor (2x60mg) + placebo, SDTA and LDTA - continuation of previous treatment. The aim of the study is to evaluate the influence of ticagrelor maintenance dose reduction from 2x90mg to 2x60mg with or without continuation of aspirin versus dual antiplatelet therapy with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose ticagrelor with aspirin (LDTA) | Experimental | Drug: Ticagrelor 60mg, Drug: AspirinPatients with ACS in this arm will be subject to reduction of ticagrelor maintenance dose from 2x90mg to 2x60mg after the first month post-ACS, and will receive the following antiplatelet therapy: 1. ticagrelor 2x90mg + aspirin 1x100mg during the first 30 days after ACS; 2. ticagrelor 2x60mg + aspirin 1x100mg starting from day 31 until 12 months after ACS. |
| Low-dose ticagrelor with placebo (LDTP) | Experimental | Drug: Ticagrelor 60mgPatients with ACS in this arm will be subject to reduction of ticagrelor maintenance dose from 2x90mg to 2x60mg after the first month post-ACS, followed by discontinuation of aspirin after 3 months post-ACS, and will receive the following antiplatelet therapy: 1. ticagrelor 2x90mg + aspirin 1x100mg during the first 30 days after ACS; 2. ticagrelor 2x60mg + aspirin 1x100mg starting from day 31 until day 90 after ACS; 3. ticagrelor 2x60mg + placebo starting from day 91 until 12 months after ACS. |
| Standard-dose ticagrelor with aspirin (SDTA) | Active comparator | Drug: Ticagrelor 90mg, Drug: AspirinPatients with ACS in this arm will receive standard dual antiplatelet therapy including ticagrelor 2x90mg + aspirin 1x100mg during the whole 12 months after ACS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- diagnosis of STEMI or NSTEMI or unstable angina
- for patients with STEMI, the following three inclusion criteria will have to be met: 1) new ST-elevation at the J-point in two contiguous leads with the cut-point ≥1 mm in all leads other than leads V2-V3, where the following cut-points apply: ≥2mm in men ≥40 years; ≥2.5 mm in men <40 years, or ≥1.5 mm in women regardless of age; or a new left bundle-branch block 2) the intention to perform primary PCI 3) detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit
- for patients with NSTEMI or unstable angina, at least two of the following three criteria will have to be met:
- <!-- -->
Key exclusion criteria (7 listed)
- contraindications to ticagrelor or/and aspirin
- indications for oral anticoagulation therapy
- second or third grade atrio-ventricular block
- previous stent thrombosis on treatment with ticagrelor
- end stage kidney disease with glomerular filtration rate <15 mL/min or on haemodialysis
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 |
|---|---|---|
| Ticagrelor 90mgAlso: BriliqueUp to day 30 after ACS, all enrolled patients will receive standard-dose ticagrelor 2x90mg as a part of dual antiplatelet therapy. Participants in SDTA arm will continue treatment with ticagrelor 2x90mg until 12 months post-ACS, while patients in LDTA and LDTP will be switched to low-dose ticagrelor 2x60 mg starting on day 31. | Drug | Standard-dose ticagrelor with aspirin (SDTA) |
| Ticagrelor 60mgAlso: BriliqueStarting from day 31, LDTA and LDTP patients will receive low-dose ticagrelor 2x60mg until 12 months post-ACS. | Drug | Low-dose ticagrelor with aspirin (LDTA), Low-dose ticagrelor with placebo (LDTP) |
| AspirinAlso: acetylsalicylic acidUp to day 90 after ACS, all enrolled patients will receive aspirin 1x100mg as a part of dual antiplatelet therapy. Starting from day 91, LDTP patients will discontinue aspirin and proceed with low-dose ticagrelor monotherapy until 12 months post-ACS, while patients in LDTA and SDTA will continue aspirin 1x100 mg until 12 months post-ACS. | Drug | Low-dose ticagrelor with aspirin (LDTA), Standard-dose ticagrelor with aspirin (SDTA) |
Primary outcome
BARC type 2, 3 or 5 bleeding
Time frame: 12 months after ACS
The primary safety composite end point of this study is the first occurrence of type 2, 3 or 5 bleeding according to the BARC criteria, occurring during the first 12 months after ACS.
Death from any cause, nonfatal MI or nonfatal stroke.
Time frame: 12 months after ACS
The primary efficacy end point is the composite of death from any cause, first nonfatal MI, or first nonfatal stroke.
11 secondary outcomes
Death from any cause, nonfatal MI, nonfatal stroke, BARC type 2, 3, or 5 bleeding.
Time frame: 12 months after ACS
BARC type 3 or 5 bleeding
Time frame: 12 months after ACS
TIMI major or minor bleeding
Time frame: 12 months after ACS
GUSTO moderate, severe, or life-threatening bleeding
Time frame: 12 months after ACS
ISTH major bleeding
Time frame: 12 months after ACS
Death from any cause
Time frame: 12 months after ACS
Death from cardiovascular causes
Time frame: 12 months after ACS
Myocardial infarction
Time frame: 12 months after ACS
Ischemic stroke
Time frame: 12 months after ACS
Definite or probable stent thrombosis
Time frame: 12 months after ACS
Dyspnea
Time frame: 12 months after ACS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Derived from this study: PubMed 34096012Kubica J, Adamski P, Niezgoda P, Kubica A, Podhajski P, Baranska M, Uminska JM, Pietrzykowski L, Ostrowska M, Siller-Matula JM, Badariene J, Bartus S, Budaj A, Dobrzycki S, Fidor L, Gasior M, Gessek J, Gierlotka M, Gil R, Goracy J, Grzelakowski P, Hajdukiewicz T, Jaguszewski M, Janion M, Kasprzak J, Kern A, Klecha A, Kleinrok A, Kochman W, Krakowiak B, Legutko J, Lesiak M, Nosal M, Piotrowski G, Przybylski A, Roleder T, Skonieczny G, Sobieszek G, Tycinska A, Wojciechowski D, Wojakowski W, Wojcik J, Zielinska M, Zurakowski A, Specchia G, Gorog DA, Navarese EP. A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study. Cardiol J. 2021;28(4):607-614. doi: 10.5603/CJ.a2021.0056. Epub 2021 Jun 7.
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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.
Jacek Kubica, MD, PhD principal investigator
Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
Eliano Navarese, MD, PhD principal investigator
Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor 90mg, Ticagrelor 60mg and Aspirin in people with STEMI and NSTEMI, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
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 15 inclusion and 7 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Piotr Adamski, MD, PhD (+48 52 585 4023, piotr.adamski@cm.umk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BARC type 2, 3 or 5 bleeding (time frame: 12 months after ACS). The study lists 2 primary outcomes in all. 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 NCT04718025, 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 21 Apr 2023.