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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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)…

Interventistico5100 partecipanti ricercati113 centri17 paesi

Categorie

Cardiovascolare100%

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

  • Acute Myocardial Infarction
  • Coronary Artery Disease

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseNon applicabile
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoSINGLE (1)
Arruolamento5100 partecipanti ricercati

Sponsor e collaboratori

  • Population Health Research Institute Sponsor

Bracci e interventi

  • 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.

Interventi

  • Procedura Angiography-guided NCL PCI

    PCI will be performed as per local practice

  • Procedura 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.

Esiti misurati

  1. Esito primario

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

    Orizzonte temporale at study completion, a minimum of 2 years

  2. Esito primario

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

    Orizzonte temporale at study completion, a minimum of 2 years

  3. Esito secondario

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

    Orizzonte temporale at study completion, a minimum of 2 years

  4. Esito secondario

    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.

    Orizzonte temporale at study completion, a minimum of 2 years

Date

Data di inizio22 giugno 2023 (effettiva)
Conclusione primaria1 giugno 2028 (stimata)
Conclusione1 giugno 2028 (stimata)
Prima pubblicazione27 gennaio 2023 (effettiva)
Ultimo aggiornamento19 giugno 2025
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltagiugno 2025

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

113 centri stanno reclutando

Australia

StrutturaCittàStato o regioneStato
Westmead HospitalWestmeadNew South WalesIn reclutamento

Austria

StrutturaCittàStato o regioneStato
Klinik FloridsdorfViennaIn reclutamento

Canada

StrutturaCittàStato o regioneStato
William Osler Health SystemBramptonIn reclutamento
University of Alberta Hospital, Mazankowski HeartEdmontonIn reclutamento
Hamilton Health SciencesHamiltonIn reclutamento
Kingston Health Sciences CentreKingstonIn reclutamento
St. Mary's General HospitalKitchenerIn reclutamento
London Health Sciences CentreLondonIn reclutamento
McGill University Health Centre (MUHC)MontrealQuebecIn reclutamento
Hopital du Sacre-Coeur de MontrealMontrealIn reclutamento
Centre Hospitalier de l'Universite de MontrealMontrealIn reclutamento
Southlake Regional Health CentreNewmarketIn reclutamento
Nova Scotia HealthNova ScotiaIn reclutamento
University of Ottawa Heart InstituteOttawaIn reclutamento
Institut Universitaire de Cardiologie et de Pneumologie de QuébecQuébecIn reclutamento
Regina General HospitalReginaIn reclutamento
Royal University HospitalSaskatoonIn reclutamento
Niagara HealthSt. CatharinesIn reclutamento
Newfoundland and Labrador Health ServicesSt. John'sIn reclutamento
Thunder Bay Regional Health Sciences CentreThunder BayIn reclutamento
Sunnybrook Health Sciences CentreTorontoIn reclutamento
St. Michael's Hospital (Unity Health Toronto)TorontoIn reclutamento
Ciusss McQ - ChaurTrois-RivièresIn reclutamento
St Paul's HospitalVancouverIn reclutamento
Vancouver General HospitalVancouverIn reclutamento
St. Boniface HospitalWinnipegIn reclutamento

Czechia

StrutturaCittàStato o regioneStato
St. Anne's University HospitalBrnoIn reclutamento

Denmark

StrutturaCittàStato o regioneStato
Aalborg University HospitalAalborgIn reclutamento
Aarhus University HospitalAarhusIn reclutamento
Rigshospitalet - Copenhagen University HospitalCopenhagenIn reclutamento

Finland

StrutturaCittàStato o regioneStato
Helsinki University HospitalHelsinkiIn reclutamento
TAYS Sydankeskus OyTampereIn reclutamento
Turku University HospitalTurkuIn reclutamento

Germany

StrutturaCittàStato o regioneStato
St. Vinzenz-HospitalCologneIn reclutamento
Helios Amper-KlinikumDachauIn reclutamento
Universitatsklinikum FrankfurtFrankfurtIn reclutamento
MarienkrankenhausHamburgIn reclutamento
Schoen Klink HamburgHamburgIn reclutamento
University Heart & Vascular Center HamburgHamburgIn reclutamento
WKK HeideHeideIn reclutamento

Hungary

StrutturaCittàStato o regioneStato
Gottsegen National Cardiovascular CenterBudapestIn reclutamento
University of SzegedSzegedIn reclutamento

India

StrutturaCittàStato o regioneStato
The Madras Medical MissionChennaiTamil NaduIn reclutamento
Apollo HospitalChennaiTamil NaduIn reclutamento
Lisie HospitalErnākulamKeralaIn reclutamento
Medicover HospitalsHyderabadIn reclutamento
Apollo Rajshree HospitalsIndoreMadhya PradeshIn reclutamento
Rukmani Birla HospitalJaipurRajasthanIn reclutamento
Meditrina HospitalKollamKeralaIn reclutamento
Caritas Hospital TrustKottayamKeralaIn reclutamento

Nella scheda del registro sono indicati altri 63 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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