NCT01740479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,042

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

6.3 years

First QC Date

November 27, 2012

Last Update Submit

February 5, 2021

Conditions

Acute Myocardial InfarctionCoronary Artery Disease

Keywords

STEMIticagrelormulti-vessel diseaseculprit lesion

Outcome Measures

Primary Outcomes (2)

  • Composite of Cardiovascular death or new myocardial Infarction

    Co-primary outcome: CV death or new MI

    over duration of follow-up (average of approximately 4 years)

  • Composite of cardiovascular death, new myocardial infarction or ischemia-driven revascularization

    Co-primary outcome: CV death, new MI or IDR

    over duration of follow-up (average of approximately 4 years)

Secondary Outcomes (1)

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

    Over duration of follow-up (average of approximately 4 years)

Other Outcomes (1)

  • Major Bleeding

    Over duration of follow-up (average of approximately 4 years)

Study Arms (2)

Complete Revascularization Strategy

ACTIVE COMPARATOR

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).

Procedure: Complete Revascularization Strategy

Optimal Medical Therapy Alone

NO INTERVENTION

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).

Interventions

Complete Revascularization StrategyPROCEDURE

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.

Also known as: Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy
Complete Revascularization Strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

Related Publications (4)

  • 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.

    PMID: 34320839DERIVED

  • 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.

    PMID: 32646305DERIVED

  • 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.

    PMID: 31475795DERIVED

  • 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.

    PMID: 31326681DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Shamir R Mehta, MD, MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 4, 2012

Study Start

February 1, 2013

Primary Completion

June 7, 2019

Study Completion

June 7, 2019

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

CA(1)