Effectiveness study of complete versus culprit-only revascularization strategies to treat multi vessel disease after primary PCI for STEMI
Conditions
Interventions
Trade Name: TICAGRELOR
Product Name: Ticagrelor
Pharmaceutical Form: Tablet
INN or Proposed INN: TICAGRELOR
CAS Number: 274693-27-5
Sponsors
Population Health Research Institute
Eligibility
Sex/Gender
All
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 pharmacoinvasive strategy where PCI is performed routinely 3-12 hours after initiation of 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: (i) at least 70% diameter stenosis (visual estimation) or (ii) at least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ? 0.80 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1950 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1950
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether, on a background of optimal medical therapy with low dose ASA and ticagrelor, a strategy of multi-vessel 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 new MI in patients with multi-vessel disease who have undergone successful culprit lesion primary PCI for STEMI.; Secondary Objective: 1. To determine whether complete revascularization reduces the composite of CV death, new MI or ischemia-driven revascularization 2. To determine whether the initial strategy of complete revascularization improves angina control, as assessed by the Seattle Angina Questionnaire (SAQ) Frequency Scale, and health-related quality of life, as assessed by the EQ-5D Quality of Life scale at 6 months and 5 year/final follow up compared to baseline. ;Primary end point(s): Cardiovascular death or new myocardial infarction;Timepoint(s) of evaluation of this end point: until death or new event | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Composite of CV death, new MI or ischemia-driven revascularization. 2. Changes in Angina Status as per Seattle Angina Questionnaire Angina Frequency Scale and changes in health-related quality of life from baseline, at 6 months and 5 year/final visit, based on the EQ-5D Quality of Life Scale. ;Timepoint(s) of evaluation of this end point: 5 YEARS | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Malaysia, Mexico, New Zealand, Norway, Poland, Romania, Russian Federation, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactJosé Luis Lopez Sendón
José Luis Lopez Sendón
Outcome results
None listed