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Acute Myocardial InfarctionCOMPLETENCT01740479

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

A study testing Complete Revascularization Strategy in people with Acute Myocardial Infarction and Coronary Artery Disease, run by Population Health Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Complete Revascularization Strategy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,042 participants
Where
1 siteCanada
Study dates
1 Feb 2013to 7 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hamilton General Hospital

    Hamilton, Ontario, L8L2X2

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Complete Revascularization Strategy
Keywords
STEMI, ticagrelor, multi-vessel disease, culprit lesion
Medical subject headings
Coronary Artery Disease, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complete Revascularization StrategyProcedure or surgery

    Also called 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 plus optimal medical therapy.

Study groups in NCT01740479
Study groupRoleWhat they receive
Complete Revascularization StrategyActive comparatorComplete 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).
Receives: Procedure: Complete Revascularization Strategy
Optimal Medical Therapy AloneNo interventionCulprit 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of Cardiovascular death or new myocardial Infarction

    Co-primary outcome: CV death or new MI

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

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

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

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

Secondary outcomes (1)

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study start1 Feb 2013
  3. Primary completion7 Jun 2019
  4. Study completion7 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,042 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01740479
Sponsor's protocol ID
COMPLETE-2012
Acronym
COMPLETE
Status last verified
Feb 2021
First submitted
27 Nov 2012
Last updated
9 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Madanchi M, Pinilla-Echeverri N, Wood DA, Sheth T, Storey RF, Kunadian V, Campo G, Moreno R, Mehran R, Rao SV, Bainey KR, Cieza T, Nguyen H, Mani T, Cairns JA, Mehta SR. Impact of Revascularization Completeness on Cardiovascular Outcomes in STEMI With Multivessel Disease. Circ Cardiovasc Interv. 2026 Jun 3:e016515. doi: 10.1161/CIRCINTERVENTIONS.126.016515. Online ahead of print.

    PubMed 42233186

  • 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.

    PubMed 34320839

  • 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.

    PubMed 32646305

  • 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.

    PubMed 31475795

  • 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.

    PubMed 31326681

Questions about this trial

What is this clinical trial studying?

A study testing Complete Revascularization Strategy in people with Acute Myocardial Infarction and Coronary Artery Disease, run by Population Health Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Cardiovascular death or new myocardial Infarction (time frame: over duration of follow-up (average of approximately 4 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01740479, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.

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