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

Sponsor: Population Health Research Institute

NCT ID: NCT05701358

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Physiology-guided NCL PCI (procedure), Angiography-guided NCL PCI (procedure)
How long the study runs
Study runs about 60 months (dates as stated)
About the drug or intervention
Physiology-guided NCL PCI — procedure: For RFR, PCI will be performed as per local practice for all lesions with RFR ≤0.89. · Angiography-guided NCL PCI — procedure: PCI will be performed as per local practice
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at people who have had a heart attack (acute myocardial infarction) caused by a blocked heart artery, and who also have other narrowed heart arteries. It compares two ways of deciding which of these other narrowings need treatment with a procedure called PCI (percutaneous coronary intervention, which uses a small balloon and usually a stent to open the artery).

Who can take part

  • You had a STEMI or type 1 NSTEMI heart attack and had the artery that caused it successfully opened with PCI within the past 72 hours
  • You have at least one more narrowed heart artery that could be treated with PCI, is narrowed by at least 50%, and is at least 2.5 mm wide
  • Your doctors plan to fully treat all the remaining narrowed arteries for this heart attack

Who may not be able to

  • You have had, or are planning to have, heart bypass surgery (CABG)
  • Doctors cannot clearly identify which artery caused your heart attack
  • You had PCI on a different narrowed artery within 45 days before joining the study
  • Your doctors plan to treat all the other narrowed areas with medicines only, not PCI
  • One of the other narrowed areas is very severe (more than 90% narrowed) or blood flow through it is reduced
  • Your only other narrowed artery is completely blocked long-term (a chronic total occlusion) — though you can join if you have this plus other treatable narrowings
  • The only other narrowed artery is in the same artery as the one that caused your heart attack
  • Your heart attack was caused by something other than the usual fatty-plaque process (for example a tear in the artery or a blockage from a clot elsewhere)
  • You have another illness that means you are expected to live less than 2 years
  • Any other medical, travel, or personal reason that would make taking part or 5 years of check-ups impractical

What taking part involves

  • • The study compares two ways of deciding how to treat the other narrowed heart arteries, but the exact procedures are not described in the registry data — ask the trial team

Time commitment: Not stated — ask the trial team (the data mentions 5 years of follow-up, but visit details are not given).

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
5,100
Started
2023-06-22
Last checked
2025-06

Plain English Summary

What is this study?

  • • Testing a new treatment for acute myocardial infarction
  • • NA - 5,100 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with acute myocardial infarction

Where?

  • • Ashford - East Kent Hospitals University NHS Foundation Trust
  • • Blackpool - Blackpool Teaching Hospitals
  • • Dundee - Ninewells Hospital
  • • Harefield - Harefield Hospital
  • • +15 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Acute Myocardial InfarctionCoronary Artery Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
  • ✓Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that...
  • ✓Amenable to successful treatment with PCI
  • ✓At least 50% diameter stenosis by visual estimation
  • ✓At least 2.5 mm in diameter

Who cannot take part

  • ✗Planned or prior coronary artery bypass graft (CABG) surgery
  • ✗Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG...
  • ✗Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
  • ✗Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
  • ✗Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter...
See the full criteria
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

Where Is This Study? (19 UK sites)

East Kent Hospitals University NHS Foundation Trust

Ashford, United Kingdom

Recruiting
Site contact (verified)
Rajiv Rampat, MDPrincipal Investigator

Blackpool Teaching Hospitals

Blackpool, United Kingdom

Recruiting
Site contact (verified)
Gavin Galasko, MDPrincipal Investigator

Ninewells Hospital

Dundee, United Kingdom

Recruiting
Site contact (verified)
John Irving, MDPrincipal Investigator

Harefield Hospital

Harefield, United Kingdom

Recruiting
Site contact (verified)
Mohammed Akhtar, MDPrincipal Investigator

Kettering General Hospital

Kettering, United Kingdom

Recruiting
Site contact (verified)
Simon Hetherington, MDPrincipal Investigator

University Hospitals of Leicester

Leicester, United Kingdom

Recruiting
Site contact (verified)
Andrew Ladwiniec, MDPrincipal Investigator

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Recruiting
Site contact (verified)
Joel Giblett, MDPrincipal Investigator

Barts Health NHS Trust

London, United Kingdom

Recruiting
Site contact (verified)
Dan Jones, MDPrincipal Investigator

Imperial College Healthcare NHS Trust

London, United Kingdom

Recruiting
Site contact (verified)
Sukhjinder Nijjer, MDPrincipal Investigator

Royal Free London NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
Sundeep Kalra, MDPrincipal Investigator

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Recruiting
Site contact (verified)
Jaydeep Sarma, MDPrincipal Investigator

The James Cook University Hospital

Middlesbrough, United Kingdom

Recruiting
Site contact (verified)
David Austin, MDPrincipal Investigator

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Recruiting
Site contact (verified)
Mohammad Alkhalil, MDPrincipal Investigator

Royal Berkshire Foundation NHS Trust

Reading, United Kingdom

Recruiting
Site contact (verified)
Neil Ruparelia, MDPrincipal Investigator

Sheffield Teaching Hospitals

Sheffield, United Kingdom

Recruiting
Site contact (verified)
James Richardson, MDPrincipal Investigator

East and North Hertfordshire NHS Trust

Stevenage, United Kingdom

Recruiting
Site contact (verified)
Manivannan Srinivasan, MDPrincipal Investigator

Royal Cornwall Hospitals NHS Trust

Truro, United Kingdom

Recruiting
Site contact (verified)
Sen Devadathan, MDPrincipal Investigator

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Recruiting
Site contact (verified)
Benjamin Wrigley, MDPrincipal Investigator

Worcestershire Acute Hospitals NHS Trust

Worcester, United Kingdom

Recruiting
Site contact (verified)
Helen Routledge, MDPrincipal Investigator

How to Get in Touch

COMPLETE-2 Project Office

Sponsor contact

CONTACT

(905) 521-2100 complete-2@phri.ca
Data sourced from ClinicalTrials.gov · Last verified: 2025-06