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.
Brief Title
Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Myocardial Infarction
Coronary Artery Disease
Eligibility 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
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
Inclusion 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
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
Gender
All
Gender Based
false
Keywords
STEMI
ticagrelor
multi-vessel disease
culprit lesion
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01740479
Org Class
Other
Org Full Name
Population Health Research Institute
Org Study Id
COMPLETE-2012
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
Co-primary outcome: CV death or new MI
Outcome Measure
Composite of Cardiovascular death or new myocardial Infarction
Outcome Time Frame
over duration of follow-up (average of approximately 4 years)
Outcome Description
Co-primary outcome: CV death, new MI or IDR
Outcome Measure
Composite of cardiovascular death, new myocardial infarction or ischemia-driven revascularization
Outcome Time Frame
over duration of follow-up (average of approximately 4 years)
Secondary Outcomes
Outcome Time Frame
Over duration of follow-up (average of approximately 4 years)
Outcome Measure
Composite of CV death, new MI, ischemia-driven revascularization or hospitalization for unstable angina or heart failure
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mark Menegus
Investigator Email
mmenegus@montefiore.org
Investigator Phone
Categories Mesh Debug
Blood Disorders --- CORONARY ARTERY DISEASE
Heart/Cardiovascular --- CORONARY ARTERY DISEASE
Heart/Cardiovascular --- MYOCARDIAL ISCHEMIA
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- ARTERIOSCLEROSIS
Heart/Cardiovascular --- ARTERIAL OCCLUSIVE DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Heart/Cardiovascular --- MYOCARDIAL INFARCTION
Heart/Cardiovascular --- INFARCTION
Heart/Cardiovascular --- ISCHEMIA
MeSH Terms
CORONARY ARTERY DISEASE
ST ELEVATION MYOCARDIAL INFARCTION
CORONARY DISEASE
MYOCARDIAL ISCHEMIA
HEART DISEASES
CARDIOVASCULAR DISEASES
ARTERIOSCLEROSIS
ARTERIAL OCCLUSIVE DISEASES
VASCULAR DISEASES
MYOCARDIAL INFARCTION
INFARCTION
ISCHEMIA
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
NECROSIS