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 March 2015 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: March 23, 2015
Last verified: March 2015
  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: Complete Revascularization Strategy

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: 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).

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
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).


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: March 23, 2015
Health Authority: Australia: Research Ethics Committee
Canada: Research Ethics Committee
Greece: Research Ethics Committee
Italy: Research Ethics Committee
Mexico: Research Ethics Committee
Romania: Research Ethics Committee
Serbia: Research Ethics Committee
United Kingdom: Research Ethics Committee
USA: Research Ethics Committee

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 August 02, 2015