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NCT05701358ClinicalTrials.gov

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies & an Observational Study of Optical Coherence Tomography in Patients With Acute MI & Multivessel Coronary Artery Disease

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En resumen

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD)…

De intervención5100 participantes buscados113 centros17 países

Categorías

Cardiovascular100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2023-01-27; recorded start 2023-06-22
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 34 other studies in this databaseCounted from the lead sponsor named in the record (Population Health Research Institute)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: other.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding7/20

    Single-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 113 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 5,100 participants (target), run at 113 sites, across 17 countries.

How this score is built
  • Enrolment36/40

    5,100 participants (target)

  • Site count23/25

    113 sites

  • Country count15/15

    17 countries

  • Planned duration10/10

    Planned over about 60 months

  • Sponsor scale5/10

    Population Health Research Institute has led 36 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

COMPLETE-2 STUDY OBJECTIVES 1. To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular (CV) death, new myocardial infarction (MI) or ischemia-driven revascularization (IDR). 2. To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

Afecciones

  • Acute Myocardial Infarction
  • Coronary Artery Disease

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: 1. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI 2. Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria: 1. Amenable to successful treatment with PCI 2. At least 50% diameter stenosis by visual estimation 3. At least 2.5 mm in diameter 3. Planned complete revascularization strategy for qualifying MI Exclusion Criteria: 1. Planned or prior coronary artery bypass graft (CABG) surgery 2. Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities 3. Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization 4. Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI) 5. Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter stenosis 6. Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible) 7. The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion 8. Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism 9. Non-cardiovascular co-morbidity with expected life expectancy \<2 years 10. Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseNo aplicable
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoSINGLE (1)
Inscripción5100 participantes buscados

Patrocinador y colaboradores

  • Population Health Research Institute Patrocinador

Grupos e intervenciones

  • Physiology-guided Non-Culprit-Lesion (NCL) PCIACTIVE_COMPARATOR

    Patients randomized to this group will have their physiology assessment using RFR and/or FFR of all qualifying NCLs that were identified prior to randomization. Other validated non-hyperemic physiology ratios (eg. iFR) may only be used when RFR is not available.

  • Angiography-guided NCL PCIOTHER

    Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.

Intervenciones

  • Procedimiento Angiography-guided NCL PCI

    PCI will be performed as per local practice

  • Procedimiento Physiology-guided NCL PCI

    For RFR, PCI will be performed as per local practice for all lesions with RFR ≤0.89. For FFR, PCI will be performed as per local practice for all NCLs with FFR ≤0.80.

Variables de resultado

  1. Variable de resultado principal

    Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR

    Plazo at study completion, a minimum of 2 years

  2. Variable de resultado principal

    Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.

    Plazo at study completion, a minimum of 2 years

  3. Variable de resultado secundaria

    Time to first occurrence of the composite of CV death or new MI.

    Plazo at study completion, a minimum of 2 years

  4. Variable de resultado secundaria

    Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

    Plazo at study completion, a minimum of 2 years

Fechas

Fecha de inicio22 de junio de 2023 (real)
Finalización principal1 de junio de 2028 (estimada)
Finalización1 de junio de 2028 (estimada)
Primera publicación27 de enero de 2023 (real)
Última actualización19 de junio de 2025
Resultados publicadosNo indicado en el registro
Estado verificado por última vezjunio de 2025

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

113 centros están en reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Westmead HospitalWestmeadNew South WalesEn reclutamiento

Austria

CentroCiudadEstado o regiónEstado
Klinik FloridsdorfViennaEn reclutamiento

Canada

CentroCiudadEstado o regiónEstado
William Osler Health SystemBramptonEn reclutamiento
University of Alberta Hospital, Mazankowski HeartEdmontonEn reclutamiento
Hamilton Health SciencesHamiltonEn reclutamiento
Kingston Health Sciences CentreKingstonEn reclutamiento
St. Mary's General HospitalKitchenerEn reclutamiento
London Health Sciences CentreLondonEn reclutamiento
McGill University Health Centre (MUHC)MontrealQuebecEn reclutamiento
Hopital du Sacre-Coeur de MontrealMontrealEn reclutamiento
Centre Hospitalier de l'Universite de MontrealMontrealEn reclutamiento
Southlake Regional Health CentreNewmarketEn reclutamiento
Nova Scotia HealthNova ScotiaEn reclutamiento
University of Ottawa Heart InstituteOttawaEn reclutamiento
Institut Universitaire de Cardiologie et de Pneumologie de QuébecQuébecEn reclutamiento
Regina General HospitalReginaEn reclutamiento
Royal University HospitalSaskatoonEn reclutamiento
Niagara HealthSt. CatharinesEn reclutamiento
Newfoundland and Labrador Health ServicesSt. John'sEn reclutamiento
Thunder Bay Regional Health Sciences CentreThunder BayEn reclutamiento
Sunnybrook Health Sciences CentreTorontoEn reclutamiento
St. Michael's Hospital (Unity Health Toronto)TorontoEn reclutamiento
Ciusss McQ - ChaurTrois-RivièresEn reclutamiento
St Paul's HospitalVancouverEn reclutamiento
Vancouver General HospitalVancouverEn reclutamiento
St. Boniface HospitalWinnipegEn reclutamiento

Czechia

CentroCiudadEstado o regiónEstado
St. Anne's University HospitalBrnoEn reclutamiento

Denmark

CentroCiudadEstado o regiónEstado
Aalborg University HospitalAalborgEn reclutamiento
Aarhus University HospitalAarhusEn reclutamiento
Rigshospitalet - Copenhagen University HospitalCopenhagenEn reclutamiento

Finland

CentroCiudadEstado o regiónEstado
Helsinki University HospitalHelsinkiEn reclutamiento
TAYS Sydankeskus OyTampereEn reclutamiento
Turku University HospitalTurkuEn reclutamiento

Germany

CentroCiudadEstado o regiónEstado
St. Vinzenz-HospitalCologneEn reclutamiento
Helios Amper-KlinikumDachauEn reclutamiento
Universitatsklinikum FrankfurtFrankfurtEn reclutamiento
MarienkrankenhausHamburgEn reclutamiento
Schoen Klink HamburgHamburgEn reclutamiento
University Heart & Vascular Center HamburgHamburgEn reclutamiento
WKK HeideHeideEn reclutamiento

Hungary

CentroCiudadEstado o regiónEstado
Gottsegen National Cardiovascular CenterBudapestEn reclutamiento
University of SzegedSzegedEn reclutamiento

India

CentroCiudadEstado o regiónEstado
The Madras Medical MissionChennaiTamil NaduEn reclutamiento
Apollo HospitalChennaiTamil NaduEn reclutamiento
Lisie HospitalErnākulamKeralaEn reclutamiento
Medicover HospitalsHyderabadEn reclutamiento
Apollo Rajshree HospitalsIndoreMadhya PradeshEn reclutamiento
Rukmani Birla HospitalJaipurRajasthanEn reclutamiento
Meditrina HospitalKollamKeralaEn reclutamiento
Caritas Hospital TrustKottayamKeralaEn reclutamiento

En el registro figuran 63 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05701358