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

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ClinicalTrials.gov Identifier: NCT05701358
Recruitment Status : Recruiting
First Posted : January 27, 2023
Last Update Posted : August 24, 2023
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Coronary Artery Disease Procedure: Physiology-guided NCL PCI Procedure: Angiography-guided NCL PCI Not Applicable

Detailed Description:

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 22, 2023
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : June 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Physiology-guided Non-Culprit-Lesion (NCL) PCI
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.
 Procedure: 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.
Angiography-guided NCL PCI
Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.
 Procedure: Angiography-guided NCL PCI
PCI will be performed as per local practice


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Time to first occurrence of the composite of CV death or new MI. [ Time Frame: at study completion, a minimum of 2 years ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05701358


Contacts
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Contact: COMPLETE-2 Project Office (905) 521-2100 complete-2@phri.ca

Locations
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Canada
Hamilton Health Sciences Recruiting
Hamilton, Canada
Contact: Matthew Sibbald, MD         
Sponsors and Collaborators
Population Health Research Institute
Investigators
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Principal Investigator: Shamir Mehta, MD Population Health Research Institute
More Information
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT05701358    
Other Study ID Numbers: COMPLETE-2
First Posted: January 27, 2023    Key Record Dates
Last Update Posted: August 24, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Population Health Research Institute:
NSTEMI
STEMI
multi-vessel disease
optical coherence tomography
 FFR
RFR
percutaneous coronary intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases