Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI (COMPLETE)
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ClinicalTrials.gov Identifier: NCT01740479 |
Recruitment Status
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Active, not recruiting
First Posted
: December 4, 2012
Last Update Posted
: March 29, 2018
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Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE |
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 |
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 |
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 |
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Condition ICMJE |
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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 |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
4042 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | Dr. Shamir Mehta, Population Health Research Institute | ||||
Study Sponsor ICMJE | Population Health Research Institute | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |