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OpenTrials
Completed

NCT Number: NCT01740479

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

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.

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complete Revascularization Strategy

Procedure

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.

Other names: Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy

Primary outcomes

  1. Composite of Cardiovascular death or new myocardial Infarction

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

    Co-primary outcome: CV death or new MI

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

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

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

Secondary outcomes

  1. 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 outcomes

  1. Major Bleeding

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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study 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

Acronym: COMPLETE

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2012
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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