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

Tracking Information
First Submitted Date ICMJE	November 27, 2012
First Posted Date ICMJE	December 4, 2012
Last Update Posted Date	March 29, 2018
Actual Study Start Date ICMJE	February 1, 2013
Estimated Primary Completion Date	October 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 26, 2018)	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; 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
Original Primary Outcome Measures ICMJE; (submitted: December 3, 2012)	Composite of Cardiovascular death or new myocardial Infarction [ Time Frame: over duration of follow-up (average of approximately 4 years) ]
Change History	Complete list of historical versions of study NCT01740479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 3, 2012)	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) ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE; (submitted: December 3, 2012)	Major Bleeding [ Time Frame: Over duration of follow-up (average of approximately 4 years) ]
Original Other Outcome Measures ICMJE	Same as current
Descriptive Information
Brief Title ICMJE	Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI
Official Title ICMJE	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
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Acute Myocardial Infarction; Coronary Artery Disease
Intervention ICMJE	Procedure: Complete Revascularization Strategy; 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 Name: Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy
Study Arms	Active Comparator: Complete Revascularization Strategy 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). Intervention: Procedure: Complete Revascularization Strategy; No Intervention: Optimal Medical Therapy Alone 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).
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: March 26, 2018)	4042
Original Estimated Enrollment ICMJE; (submitted: December 3, 2012)	3900
Estimated Study Completion Date	April 2019
Estimated Primary Completion Date	October 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01740479
Other Study ID Numbers ICMJE	COMPLETE-2012
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	Dr. Shamir Mehta, Population Health Research Institute
Study Sponsor ICMJE	Population Health Research Institute
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Shamir R Mehta, MD, MSc McMaster University
PRS Account	Population Health Research Institute
Verification Date	March 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP