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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. (see Contacts and Locations)
Verified April 2013 by Population Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Dr. Shamir Mehta, Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01740479
First received: November 27, 2012
Last updated: April 24, 2013
Last verified: April 2013

November 27, 2012
April 24, 2013
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Same as current
Major Bleeding [ Time Frame: Over duration of follow-up (average of approximately 4 years) ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Acute Myocardial Infarction
  • Coronary Artery Disease
  • Percutaneous Coronary Intervention
Procedure: PCI for non-culprit lesions
Additional PCI procedure
  • Active Comparator: Multi-vessel revascularization
    Additional PCI for non-culprit lesions
    Intervention: Procedure: PCI for non-culprit lesions
  • No Intervention: Medical Therapy
    Optimal medical therapy as per current guidelines
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
Both
Not Provided
No
Contact: Research Coordinator, BSc, MSc 1-866-414-7474 complete@phri.ca
Canada
 
NCT01740479
COMPLETE-2012
Yes
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
April 2013

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