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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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)…

تدخّليةمطلوب 5,100 مشارك113 موقعاً17 دولة

الفئات

القلب والأوعية الدموية100%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

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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.

ملخص

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.

الحالات

  • Acute Myocardial Infarction
  • Coronary Artery Disease

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةغير منطبق
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةSINGLE (1)
التجنيدمطلوب 5,100 مشارك

الجهة الراعية والمتعاونون

  • Population Health Research Institute الجهة الراعية

الأذرع والتدخلات

  • 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.

التدخلات

  • إجراء Angiography-guided NCL PCI

    PCI will be performed as per local practice

  • إجراء 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.

مقاييس النتائج

  1. مقياس النتيجة الأولي

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

    الإطار الزمني at study completion, a minimum of 2 years

  2. مقياس النتيجة الأولي

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

    الإطار الزمني at study completion, a minimum of 2 years

  3. مقياس النتيجة الثانوي

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

    الإطار الزمني at study completion, a minimum of 2 years

  4. مقياس النتيجة الثانوي

    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.

    الإطار الزمني at study completion, a minimum of 2 years

التواريخ

تاريخ البدء22 يونيو 2023 (فعلي)
الإتمام الأولي1 يونيو 2028 (تقديري)
الإتمام1 يونيو 2028 (تقديري)
أول نشر27 يناير 2023 (فعلي)
آخر تحديث19 يونيو 2025
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيونيو 2025

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

113 موقعاً قيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Westmead HospitalWestmeadNew South Walesقيد التجنيد

Austria

المنشأةالمدينةالولاية أو المنطقةالحالة
Klinik FloridsdorfViennaقيد التجنيد

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
William Osler Health SystemBramptonقيد التجنيد
University of Alberta Hospital, Mazankowski HeartEdmontonقيد التجنيد
Hamilton Health SciencesHamiltonقيد التجنيد
Kingston Health Sciences CentreKingstonقيد التجنيد
St. Mary's General HospitalKitchenerقيد التجنيد
London Health Sciences CentreLondonقيد التجنيد
McGill University Health Centre (MUHC)MontrealQuebecقيد التجنيد
Hopital du Sacre-Coeur de MontrealMontrealقيد التجنيد
Centre Hospitalier de l'Universite de MontrealMontrealقيد التجنيد
Southlake Regional Health CentreNewmarketقيد التجنيد
Nova Scotia HealthNova Scotiaقيد التجنيد
University of Ottawa Heart InstituteOttawaقيد التجنيد
Institut Universitaire de Cardiologie et de Pneumologie de QuébecQuébecقيد التجنيد
Regina General HospitalReginaقيد التجنيد
Royal University HospitalSaskatoonقيد التجنيد
Niagara HealthSt. Catharinesقيد التجنيد
Newfoundland and Labrador Health ServicesSt. John'sقيد التجنيد
Thunder Bay Regional Health Sciences CentreThunder Bayقيد التجنيد
Sunnybrook Health Sciences CentreTorontoقيد التجنيد
St. Michael's Hospital (Unity Health Toronto)Torontoقيد التجنيد
Ciusss McQ - ChaurTrois-Rivièresقيد التجنيد
St Paul's HospitalVancouverقيد التجنيد
Vancouver General HospitalVancouverقيد التجنيد
St. Boniface HospitalWinnipegقيد التجنيد

Czechia

المنشأةالمدينةالولاية أو المنطقةالحالة
St. Anne's University HospitalBrnoقيد التجنيد

Denmark

المنشأةالمدينةالولاية أو المنطقةالحالة
Aalborg University HospitalAalborgقيد التجنيد
Aarhus University HospitalAarhusقيد التجنيد
Rigshospitalet - Copenhagen University HospitalCopenhagenقيد التجنيد

Finland

المنشأةالمدينةالولاية أو المنطقةالحالة
Helsinki University HospitalHelsinkiقيد التجنيد
TAYS Sydankeskus OyTampereقيد التجنيد
Turku University HospitalTurkuقيد التجنيد

Germany

المنشأةالمدينةالولاية أو المنطقةالحالة
St. Vinzenz-HospitalCologneقيد التجنيد
Helios Amper-KlinikumDachauقيد التجنيد
Universitatsklinikum FrankfurtFrankfurtقيد التجنيد
MarienkrankenhausHamburgقيد التجنيد
Schoen Klink HamburgHamburgقيد التجنيد
University Heart & Vascular Center HamburgHamburgقيد التجنيد
WKK HeideHeideقيد التجنيد

Hungary

المنشأةالمدينةالولاية أو المنطقةالحالة
Gottsegen National Cardiovascular CenterBudapestقيد التجنيد
University of SzegedSzegedقيد التجنيد

India

المنشأةالمدينةالولاية أو المنطقةالحالة
The Madras Medical MissionChennaiTamil Naduقيد التجنيد
Apollo HospitalChennaiTamil Naduقيد التجنيد
Lisie HospitalErnākulamKeralaقيد التجنيد
Medicover HospitalsHyderabadقيد التجنيد
Apollo Rajshree HospitalsIndoreMadhya Pradeshقيد التجنيد
Rukmani Birla HospitalJaipurRajasthanقيد التجنيد
Meditrina HospitalKollamKeralaقيد التجنيد
Caritas Hospital TrustKottayamKeralaقيد التجنيد

يُدرَج 63 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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