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Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease (COMPLETE-2)

Primary Purpose

Acute Myocardial Infarction, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physiology-guided NCL PCI
Angiography-guided NCL PCI
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring NSTEMI, STEMI, multi-vessel disease, optical coherence tomography, FFR, RFR, percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 meets all of the following criteria: Amenable to successful treatment with PCI At least 50% diameter stenosis by visual estimation At least 2.5 mm in diameter Planned complete revascularization strategy for qualifying MI Exclusion Criteria: 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 changes and/or regional wall motion abnormalities 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 stenosis 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) The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion 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 Non-cardiovascular co-morbidity with expected life expectancy <2 years Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Sites / Locations

  • Hamilton Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Physiology-guided Non-Culprit-Lesion (NCL) PCI

Angiography-guided NCL PCI

Arm Description

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.

Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 17, 2023
Last Updated
August 22, 2023
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05701358
Brief Title
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acronym
COMPLETE-2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
COMPLETE-2 STUDY OBJECTIVES 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Coronary Artery Disease
Keywords
NSTEMI, STEMI, multi-vessel disease, optical coherence tomography, FFR, RFR, percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
5100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiology-guided Non-Culprit-Lesion (NCL) PCI
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Angiography-guided NCL PCI
Arm Type
Other
Arm Description
Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.
Intervention Type
Procedure
Intervention Name(s)
Physiology-guided NCL PCI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Angiography-guided NCL PCI
Intervention Description
PCI will be performed as per local practice
Primary Outcome Measure Information:
Title
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
Time Frame
at study completion, a minimum of 2 years
Title
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
Time Frame
at study completion, a minimum of 2 years
Secondary Outcome Measure Information:
Title
Time to first occurrence of the composite of CV death or new MI.
Time Frame
at study completion, a minimum of 2 years
Title
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.
Time Frame
at study completion, a minimum of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 meets all of the following criteria: Amenable to successful treatment with PCI At least 50% diameter stenosis by visual estimation At least 2.5 mm in diameter Planned complete revascularization strategy for qualifying MI Exclusion Criteria: 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 changes and/or regional wall motion abnormalities 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 stenosis 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) The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion 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 Non-cardiovascular co-morbidity with expected life expectancy <2 years Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
COMPLETE-2 Project Office
Phone
(905) 521-2100
Email
complete-2@phri.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamir Mehta, MD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Sibbald, MD

12. IPD Sharing Statement

Learn more about this trial

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

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