Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments follow-up coronary angiography, clinical follow-up
Phase phase 4
Sponsor Takeshi Morimoto
Start date May 2010
End date May 2016
Trial size 700 participants
Trial identifier NCT01123291, C406

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention
follow-up coronary angiography
follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
(Active Comparator)
no routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention
clinical follow-up
no routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention

Primary Outcomes

Measure
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
time frame: 4.8 years

Secondary Outcomes

Measure
death
time frame: 4.8 years
cardiac death
time frame: 4.8 years
myocardial infarction
time frame: 4.8 years
stent thrombosis
time frame: 4.8 years
stroke
time frame: 4.8 years
bleeding complications
time frame: 4.8 years
any coronary revascularization
time frame: 4.8 years
clinically-driven coronary revascularization
time frame: 4.8 years
clinically-driven target-lesion revascularization
time frame: 4.8 years
any target-lesion revascularization
time frame: 4.8 years
coronary artery bypass grafting
time frame: 4.8 years
angina
time frame: 4.8 years
renal function
time frame: 4.8 years
emergency hospitalization for acute coronary syndrome
time frame: 4.8 years
hospitalization for congestive heart failure
time frame: 4.8 years
composite of cardiac death, myocardial infarction or acute coronary syndrome
time frame: 4.8 years
follow-up coronary angiography
time frame: 4.8 years
clinically-driven follow-up coronary angiography
time frame: 4.8 years

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Patients received percutaneous coronary intervention - Patients older than 20 years old - Patients who will not scheduled any staged percutaneous coronary intervention

Additional Information

Official title Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
Principal investigator Takeshi Kimura, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Kyoto University, Graduate School of Medicine.