Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial (ReACT)

Takeshi Morimoto

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Procedure: follow-up coronary angiography; Procedure: Clinical follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT01123291

C406

Details and patient eligibility

About

The purpose of this study is to evaluate the long term clinical impact of routine follow-up coronary angiography after percutaneous coronary intervention (PCI). The primary endpoint is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at 3-year after percutaneous coronary intervention.

Full description

Routine follow-up coronary angiography after percutaneous coronary intervention has been performed to detect restenosis in a lot of PCI centers in Japan. On the other hand, previous studies reported that routine follow-up coronary angiography might lead to unnecessary reinterventions in asymptomatic patients. In this situation, the effect of routine follow-up coronary angiography on long-term clinical outcomes remains unknown. The purpose of this study is to evaluate the long-term clinical impact of routine follow-up coronary angiography after PCI compared with clinical follow-up alone. The primary endpoint of this study is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at three-year after percutaneous coronary intervention. The design of this study is almost all-comer design enrolling patients received PCI without any exclusion criteria.

Enrollment: 700 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients received percutaneous coronary intervention
• Patients older than 20 years old
• Patients who will not scheduled any staged percutaneous coronary intervention

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

routine follow-up coronary angiography

Active Comparator group

Description:

routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention

Treatment:

Procedure: follow-up coronary angiography

clinical follow-up

Active Comparator group

Description:

no routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention

Treatment:

Procedure: Clinical follow-up