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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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)…

Interventionnelle5 100 participants recherchés113 sites17 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Acute Myocardial Infarction
  • Coronary Artery Disease

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhaseSans objet
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuSINGLE (1)
Recrutement5 100 participants recherchés

Promoteur et collaborateurs

  • Population Health Research Institute Promoteur

Groupes et interventions

  • 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.

Interventions

  • Intervention Angiography-guided NCL PCI

    PCI will be performed as per local practice

  • Intervention 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.

Critères de jugement

  1. Critère de jugement principal

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

    Délai at study completion, a minimum of 2 years

  2. Critère de jugement principal

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

    Délai at study completion, a minimum of 2 years

  3. Critère de jugement secondaire

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

    Délai at study completion, a minimum of 2 years

  4. Critère de jugement secondaire

    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.

    Délai at study completion, a minimum of 2 years

Dates

Date de début22 juin 2023 (réelle)
Achèvement principal1 juin 2028 (estimée)
Achèvement1 juin 2028 (estimée)
Première publication27 janvier 2023 (réelle)
Dernière mise à jour19 juin 2025
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjuin 2025

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

113 sites sont en recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Westmead HospitalWestmeadNew South WalesEn recrutement

Austria

ÉtablissementVilleÉtat ou régionStatut
Klinik FloridsdorfViennaEn recrutement

Canada

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

Czechia

ÉtablissementVilleÉtat ou régionStatut
St. Anne's University HospitalBrnoEn recrutement

Denmark

ÉtablissementVilleÉtat ou régionStatut
Aalborg University HospitalAalborgEn recrutement
Aarhus University HospitalAarhusEn recrutement
Rigshospitalet - Copenhagen University HospitalCopenhagenEn recrutement

Finland

ÉtablissementVilleÉtat ou régionStatut
Helsinki University HospitalHelsinkiEn recrutement
TAYS Sydankeskus OyTampereEn recrutement
Turku University HospitalTurkuEn recrutement

Germany

ÉtablissementVilleÉtat ou régionStatut
St. Vinzenz-HospitalCologneEn recrutement
Helios Amper-KlinikumDachauEn recrutement
Universitatsklinikum FrankfurtFrankfurtEn recrutement
MarienkrankenhausHamburgEn recrutement
Schoen Klink HamburgHamburgEn recrutement
University Heart & Vascular Center HamburgHamburgEn recrutement
WKK HeideHeideEn recrutement

Hungary

ÉtablissementVilleÉtat ou régionStatut
Gottsegen National Cardiovascular CenterBudapestEn recrutement
University of SzegedSzegedEn recrutement

India

ÉtablissementVilleÉtat ou régionStatut
The Madras Medical MissionChennaiTamil NaduEn recrutement
Apollo HospitalChennaiTamil NaduEn recrutement
Lisie HospitalErnākulamKeralaEn recrutement
Medicover HospitalsHyderabadEn recrutement
Apollo Rajshree HospitalsIndoreMadhya PradeshEn recrutement
Rukmani Birla HospitalJaipurRajasthanEn recrutement
Meditrina HospitalKollamKeralaEn recrutement
Caritas Hospital TrustKottayamKeralaEn recrutement

63 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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