NCT04718025

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

2.4 years

First QC Date

January 17, 2021

Last Update Submit

April 20, 2023

Conditions

STEMINSTEMIUnstable Angina

Keywords

ticagreloraspirinacute coronary syndrome

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12 months after ACS

Secondary Outcomes (11)

  • Death from any cause, nonfatal MI, nonfatal stroke, BARC type 2, 3, or 5 bleeding.

    12 months after ACS

  • BARC type 3 or 5 bleeding

    12 months after ACS

  • TIMI major or minor bleeding

    12 months after ACS

  • GUSTO moderate, severe, or life-threatening bleeding

    12 months after ACS

  • ISTH major bleeding

    12 months after ACS

  • +6 more secondary outcomes

Study Arms (3)

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.

Drug: Ticagrelor 60mgDrug: 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.

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.

Drug: Ticagrelor 90mgDrug: Aspirin

Interventions

Ticagrelor 90mgDRUG

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.

Also known as: Brilique
Standard-dose ticagrelor with aspirin (SDTA)
Ticagrelor 60mgDRUG

Starting from day 31, LDTA and LDTP patients will receive low-dose ticagrelor 2x60mg until 12 months post-ACS.

Also known as: Brilique
Low-dose ticagrelor with aspirin (LDTA)Low-dose ticagrelor with placebo (LDTP)
AspirinDRUG

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.

Also known as: acetylsalicylic acid
Low-dose ticagrelor with aspirin (LDTA)Standard-dose ticagrelor with aspirin (SDTA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of STEMI or NSTEMI or unstable angina
  • 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:
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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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antoni Jurasz University Hospital No. 1

Bydgoszcz, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34096012DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionNon-ST Elevated Myocardial InfarctionAngina, UnstableAcute Coronary Syndrome

Interventions

TicagrelorAspirin

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jacek Kubica, MD, PhD

    Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

    PRINCIPAL INVESTIGATOR

  • Eliano Navarese, MD, PhD

    Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Adamski, MD, PhD

CONTACT

+48 52 585 4023piotr.adamski@cm.umk.pl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr hab.

Study Record Dates

First Submitted

January 17, 2021

First Posted

January 22, 2021

Study Start

February 7, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

PL(1)