NCT01740479

Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,042 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Myocardial Infarction
• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-02-01
• Primary completion: 2019-06-07
• Completion: 2019-06-07
• First posted: 2012-12-04
• Last updated: 2021-02-09

Locations

1 site across 1 country: Canada