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Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI (COMPLETE)

Primary Purpose

Acute Myocardial Infarction, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Complete Revascularization Strategy
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myocardial Infarction focused on measuring STEMI, ticagrelor, multi-vessel disease, culprit lesion

Eligibility Criteria

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

Inclusion Criteria:

  1. Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis AND

  2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:

    • At least 70% diameter stenosis (visual estimation) or
    • At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80

Exclusion Criteria:

  1. Planned revascularization of non-culprit lesion
  2. Planned surgical revascularization
  3. Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
  4. Any factor precluding 5 year follow-up
  5. Prior Coronary Artery Bypass Graft (CABG) Surgery

Sites / Locations

  • Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Complete Revascularization Strategy

Optimal Medical Therapy Alone

Arm Description

Complete Revascularization Strategy (Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy): Staged PCI using second generation drug eluting stents (Promus Element Plus drug-eluting stent or newer version in this series is strongly recommended) of all suitable non-culprit lesions. All patients, regardless of randomized treatment allocation will receive optimal medical therapy consisting of risk factor modification and use of evidence-based therapies (including low dose acetylsalicylic acid (ASA) and ticagrelor).

Culprit lesion only Revascularization Strategy (Optimal Medical Therapy Alone): No further revascularization of non-culprit lesions. All patients, regardless of randomized treatment allocation will receive optimal medical therapy consisting of risk factor modification and use of evidence-based therapies (including low dose ASA and ticagrelor).

Outcomes

Primary Outcome Measures

Composite of Cardiovascular death or new myocardial Infarction
Co-primary outcome: CV death or new MI
Composite of cardiovascular death, new myocardial infarction or ischemia-driven revascularization
Co-primary outcome: CV death, new MI or IDR

Secondary Outcome Measures

Composite of CV death, new MI, ischemia-driven revascularization or hospitalization for unstable angina or heart failure

Full Information

First Posted
November 27, 2012
Last Updated
February 5, 2021
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01740479
Brief Title
Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI
Acronym
COMPLETE
Official Title
Randomized Comparative Effectiveness Study of Complete vs Culprit-only Revascularization Strategies to Treat Multi-vessel Disease After Early Percutaneous Coronary Intervention (PCI) for ST-segment Elevation Myocardial (STEMI) Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
June 7, 2019 (Actual)
Study Completion Date
June 7, 2019 (Actual)

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
To determine whether, on a background of optimal medical therapy, including ticagrelor, opening of all suitable narrowings or blockages found at the time of primary PCI for an acute heart attack is better than treating only the culprit lesion in patients with multi-vessel disease.
Detailed Description
To determine if a strategy of multivessel revascularization involving PCI of all suitable non-infarct related artery lesions plus optimal medical therapy is superior to a strategy of optimal medical therapy alone in reducing (1) the composite outcome of cardiovascular (CV) death or new myocardial infarction (MI), or (2) the composite of CV death, new MI or ischemia driven revascularization (IDR) in patients with multivessel disease who have undergone early successful culprit lesion PCI for STEMI.

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
STEMI, ticagrelor, multi-vessel disease, culprit lesion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4042 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complete Revascularization Strategy
Arm Type
Active Comparator
Arm Description
Complete Revascularization Strategy (Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy): Staged PCI using second generation drug eluting stents (Promus Element Plus drug-eluting stent or newer version in this series is strongly recommended) of all suitable non-culprit lesions. All patients, regardless of randomized treatment allocation will receive optimal medical therapy consisting of risk factor modification and use of evidence-based therapies (including low dose acetylsalicylic acid (ASA) and ticagrelor).
Arm Title
Optimal Medical Therapy Alone
Arm Type
No Intervention
Arm Description
Culprit lesion only Revascularization Strategy (Optimal Medical Therapy Alone): No further revascularization of non-culprit lesions. All patients, regardless of randomized treatment allocation will receive optimal medical therapy consisting of risk factor modification and use of evidence-based therapies (including low dose ASA and ticagrelor).
Intervention Type
Procedure
Intervention Name(s)
Complete Revascularization Strategy
Other Intervention Name(s)
Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy
Intervention Description
Staged PCI using second generation drug eluting stents (Promus Element Plus drug-eluting stent or newer version in this series is strongly recommended) of all suitable non-culprit lesions plus optimal medical therapy.
Primary Outcome Measure Information:
Title
Composite of Cardiovascular death or new myocardial Infarction
Description
Co-primary outcome: CV death or new MI
Time Frame
over duration of follow-up (average of approximately 4 years)
Title
Composite of cardiovascular death, new myocardial infarction or ischemia-driven revascularization
Description
Co-primary outcome: CV death, new MI or IDR
Time Frame
over duration of follow-up (average of approximately 4 years)
Secondary Outcome Measure Information:
Title
Composite of CV death, new MI, ischemia-driven revascularization or hospitalization for unstable angina or heart failure
Time Frame
Over duration of follow-up (average of approximately 4 years)
Other Pre-specified Outcome Measures:
Title
Major Bleeding
Time Frame
Over duration of follow-up (average of approximately 4 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis AND Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has: At least 70% diameter stenosis (visual estimation) or At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80 Exclusion Criteria: Planned revascularization of non-culprit lesion Planned surgical revascularization Non-cardiovascular co-morbidity reducing life expectancy to < 5 years Any factor precluding 5 year follow-up Prior Coronary Artery Bypass Graft (CABG) Surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamir R Mehta, MD, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34320839
Citation
Dehghani P, Cantor WJ, Wang J, Wood DA, Storey RF, Mehran R, Bainey KR, Welsh RC, Rodes-Cabau J, Rao S, Lavi S, Velianou JL, Natarajan MK, Ziakas A, Guiducci V, Fernandez-Aviles F, Cairns JA, Mehta SR. Complete Revascularization in Patients Undergoing a Pharmacoinvasive Strategy for ST-Segment-Elevation Myocardial Infarction: Insights From the COMPLETE Trial. Circ Cardiovasc Interv. 2021 Aug;14(8):e010458. doi: 10.1161/CIRCINTERVENTIONS.120.010458. Epub 2021 Jul 29.
Results Reference
derived
PubMed Identifier
32646305
Citation
Pinilla-Echeverri N, Mehta SR, Wang J, Lavi S, Schampaert E, Cantor WJ, Bainey KR, Welsh RC, Kassam S, Mehran R, Storey RF, Nguyen H, Meeks B, Wood DA, Cairns JA, Sheth T. Nonculprit Lesion Plaque Morphology in Patients With ST-Segment-Elevation Myocardial Infarction: Results From the COMPLETE Trial Optical Coherence Tomography Substudys. Circ Cardiovasc Interv. 2020 Jul;13(7):e008768. doi: 10.1161/CIRCINTERVENTIONS.119.008768. Epub 2020 Jul 10.
Results Reference
derived
PubMed Identifier
31475795
Citation
Mehta SR, Wood DA, Storey RF, Mehran R, Bainey KR, Nguyen H, Meeks B, Di Pasquale G, Lopez-Sendon J, Faxon DP, Mauri L, Rao SV, Feldman L, Steg PG, Avezum A, Sheth T, Pinilla-Echeverri N, Moreno R, Campo G, Wrigley B, Kedev S, Sutton A, Oliver R, Rodes-Cabau J, Stankovic G, Welsh R, Lavi S, Cantor WJ, Wang J, Nakamya J, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Complete Revascularization with Multivessel PCI for Myocardial Infarction. N Engl J Med. 2019 Oct 10;381(15):1411-1421. doi: 10.1056/NEJMoa1907775. Epub 2019 Sep 1.
Results Reference
derived
PubMed Identifier
31326681
Citation
Mehta SR, Wood DA, Meeks B, Storey RF, Mehran R, Bainey KR, Nguyen H, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Design and rationale of the COMPLETE trial: A randomized, comparative effectiveness study of complete versus culprit-only percutaneous coronary intervention to treat multivessel coronary artery disease in patients presenting with ST-segment elevation myocardial infarction. Am Heart J. 2019 Sep;215:157-166. doi: 10.1016/j.ahj.2019.06.006. Epub 2019 Jun 18.
Results Reference
derived

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Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI

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