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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

התערבותידרושים 5,100 משתתפים113 אתרים17 מדינות

קטגוריות

לב וכלי דם100%

רשום במרשם אחד

ClinicalTrials.govNCT05701358פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני חודשיים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

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

תקציר

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.

מצבים רפואיים

Acute Myocardial Infarction
Coronary Artery Disease

זכאות

זכאות
מין	הכול
גילאים	18 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	לא רלוונטי
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	SINGLE (1)
גיוס	דרושים 5,100 משתתפים

נותן חסות ושותפים

Population Health Research Institute נותן חסות

זרועות והתערבויות

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.

התערבויות

פרוצדורה Angiography-guided NCL PCI
PCI will be performed as per local practice
פרוצדורה 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.

מדדי תוצאה

מדד תוצאה ראשוני
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
מסגרת זמן at study completion, a minimum of 2 years
מדד תוצאה ראשוני
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
מסגרת זמן at study completion, a minimum of 2 years
מדד תוצאה משני
Time to first occurrence of the composite of CV death or new MI.
מסגרת זמן at study completion, a minimum of 2 years
מדד תוצאה משני
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.
מסגרת זמן at study completion, a minimum of 2 years

תאריכים

תאריכים
תאריך התחלה	22 ביוני 2023 (בפועל)
סיום ראשוני	1 ביוני 2028 (משוער)
סיום	1 ביוני 2028 (משוער)
פורסם לראשונה	27 בינואר 2023 (בפועל)
עודכן לאחרונה	19 ביוני 2025
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	יוני 2025

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

113 אתרים מגייסים

Australia

Australia
מתקן	עיר	מדינה או אזור	מצב
Westmead Hospital	Westmead	New South Wales	מגייס

Austria

Austria
מתקן	עיר	מדינה או אזור	מצב
Klinik Floridsdorf	Vienna		מגייס

Canada

Canada
מתקן	עיר	מדינה או אזור	מצב
William Osler Health System	Brampton		מגייס
University of Alberta Hospital, Mazankowski Heart	Edmonton		מגייס
Hamilton Health Sciences	Hamilton		מגייס
Kingston Health Sciences Centre	Kingston		מגייס
St. Mary's General Hospital	Kitchener		מגייס
London Health Sciences Centre	London		מגייס
McGill University Health Centre (MUHC)	Montreal	Quebec	מגייס
Hopital du Sacre-Coeur de Montreal	Montreal		מגייס
Centre Hospitalier de l'Universite de Montreal	Montreal		מגייס
Southlake Regional Health Centre	Newmarket		מגייס
Nova Scotia Health	Nova Scotia		מגייס
University of Ottawa Heart Institute	Ottawa		מגייס
Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec		מגייס
Regina General Hospital	Regina		מגייס
Royal University Hospital	Saskatoon		מגייס
Niagara Health	St. Catharines		מגייס
Newfoundland and Labrador Health Services	St. John's		מגייס
Thunder Bay Regional Health Sciences Centre	Thunder Bay		מגייס
Sunnybrook Health Sciences Centre	Toronto		מגייס
St. Michael's Hospital (Unity Health Toronto)	Toronto		מגייס
Ciusss McQ - Chaur	Trois-Rivières		מגייס
St Paul's Hospital	Vancouver		מגייס
Vancouver General Hospital	Vancouver		מגייס
St. Boniface Hospital	Winnipeg		מגייס

Czechia

Czechia
מתקן	עיר	מדינה או אזור	מצב
St. Anne's University Hospital	Brno		מגייס

Denmark

Denmark
מתקן	עיר	מצב
Aalborg University Hospital	Aalborg	מגייס
Aarhus University Hospital	Aarhus	מגייס
Rigshospitalet - Copenhagen University Hospital	Copenhagen	מגייס

Finland

Finland
מתקן	עיר	מצב
Helsinki University Hospital	Helsinki	מגייס
TAYS Sydankeskus Oy	Tampere	מגייס
Turku University Hospital	Turku	מגייס

Germany

Germany
מתקן	עיר	מצב
St. Vinzenz-Hospital	Cologne	מגייס
Helios Amper-Klinikum	Dachau	מגייס
Universitatsklinikum Frankfurt	Frankfurt	מגייס
Marienkrankenhaus	Hamburg	מגייס
Schoen Klink Hamburg	Hamburg	מגייס
University Heart & Vascular Center Hamburg	Hamburg	מגייס
WKK Heide	Heide	מגייס

Hungary

Hungary
מתקן	עיר	מדינה או אזור	מצב
Gottsegen National Cardiovascular Center	Budapest		מגייס
University of Szeged	Szeged		מגייס

India

India
מתקן	עיר	מדינה או אזור	מצב
The Madras Medical Mission	Chennai	Tamil Nadu	מגייס
Apollo Hospital	Chennai	Tamil Nadu	מגייס
Lisie Hospital	Ernākulam	Kerala	מגייס
Medicover Hospitals	Hyderabad		מגייס
Apollo Rajshree Hospitals	Indore	Madhya Pradesh	מגייס
Rukmani Birla Hospital	Jaipur	Rajasthan	מגייס
Meditrina Hospital	Kollam	Kerala	מגייס
Caritas Hospital Trust	Kottayam	Kerala	מגייס

63 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

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