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

This study is currently recruiting participants.
Verified March 2015 by Dr. Shamir Mehta, Population Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01740479
First Posted: December 4, 2012
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Shamir Mehta, Population Health Research Institute
November 27, 2012
December 4, 2012
March 24, 2015
December 2012
March 2018   (Final data collection date for primary outcome measure)
Composite of Cardiovascular death or new myocardial Infarction [ Time Frame: over duration of follow-up (average of approximately 4 years) ]
Same as current
Complete list of historical versions of study NCT01740479 on ClinicalTrials.gov Archive Site
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) ]
Same as current
Major Bleeding [ Time Frame: Over duration of follow-up (average of approximately 4 years) ]
Same as current
 
Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Primary PCI for STEMI
Randomized Comparative Effectiveness Study of Complete vs Culprit-only Revascularization Strategies to Treat Multi-vessel Disease After Primary 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.
To determine whether, on a background of optimal medical therapy with low-dose ASA and ticagrelor, a strategy of complete revascularization involving staged PCI using drug eluting stents of all suitable non-infarct related artery lesions is superior to a strategy of culprit lesion-only revascularization in reducing the composite outcome of CV death or MI in patients with multi-vessel disease who have undergone successful culprit lesion primary PCI for STEMI.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Acute Myocardial Infarction
  • Coronary Artery Disease
  • Percutaneous Coronary Intervention
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
  • 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 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).

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3900
December 2018
March 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. 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:

  1. Planned revascularization of non-culprit lesion
  2. Planned surgical revascularization
  3. Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
  4. Any factor precluding 5 year follow-up
  5. Prior Coronary Artery Bypass Graft (CABG) Surgery
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Research Coordinator, BSc, MSc 1-866-414-7474 complete@phri.ca
Canada
 
 
NCT01740479
COMPLETE-2012
Yes
Not Provided
Not Provided
Dr. Shamir Mehta, Population Health Research Institute
Population Health Research Institute
Not Provided
Principal Investigator: Shamir R Mehta, MD, MSc McMaster University
Population Health Research Institute
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP