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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
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Coronary Artery Disease
Percutaneous Coronary Intervention
Procedure: PCI for non-culprit lesions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Major Bleeding [ Time Frame: Over duration of follow-up (average of approximately 4 years) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3900
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multi-vessel revascularization
Additional PCI for non-culprit lesions
Procedure: PCI for non-culprit lesions
Additional PCI procedure
No Intervention: Medical Therapy
Optimal medical therapy as per current guidelines

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740479

Contacts
Contact: Research Coordinator, BSc, MSc 1-866-414-7474 complete@phri.ca

Locations
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L2X2
Contact: Shamir Mehta, MD    905-527-4322    smehta@mcmaster.ca   
Principal Investigator: Shamir Mehta, MD         
Sponsors and Collaborators
Population Health Research Institute
Investigators
Principal Investigator: Shamir R Mehta, MD, MSc McMaster University
  More Information

No publications provided

Responsible Party: Dr. Shamir Mehta, Principal Investigator, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01740479     History of Changes
Other Study ID Numbers: COMPLETE-2012
Study First Received: November 27, 2012
Last Updated: April 24, 2013
Health Authority: Canada: Population Health Research Institute and individual hospital IRB's

Keywords provided by Population Health Research Institute:
STEMI
ticagrelor
multi-vessel disease
culprit lesion

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014