Clinical trial NCT01123291: Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
Official title: Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: follow-up coronary angiography
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 700
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
timeFrame: 4.8 years
Secondary outcomes:
measure: death
timeFrame: 4.8 years
measure: cardiac death
timeFrame: 4.8 years
measure: myocardial infarction
timeFrame: 4.8 years
measure: stent thrombosis
timeFrame: 4.8 years
measure: stroke
timeFrame: 4.8 years
measure: bleeding complications
timeFrame: 4.8 years
measure: any coronary revascularization
timeFrame: 4.8 years
measure: clinically-driven coronary revascularization
timeFrame: 4.8 years
measure: clinically-driven target-lesion revascularization
timeFrame: 4.8 years
measure: any target-lesion revascularization
timeFrame: 4.8 years
measure: coronary artery bypass grafting
timeFrame: 4.8 years
measure: angina
timeFrame: 4.8 years
measure: renal function
timeFrame: 4.8 years
measure: emergency hospitalization for acute coronary syndrome
timeFrame: 4.8 years
measure: hospitalization for congestive heart failure
timeFrame: 4.8 years
measure: composite of cardiac death, myocardial infarction or acute coronary syndrome
timeFrame: 4.8 years
measure: follow-up coronary angiography
timeFrame: 4.8 years
measure: clinically-driven follow-up coronary angiography
timeFrame: 4.8 years
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Division of Cardiology, Kyoto University Hospital
Study officials:
affiliation: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
name: Takeshi Kimura, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shiomi H, Morimoto T, Kitaguchi S, Nakagawa Y, Ishii K, Haruna Y, Takamisawa I, Motooka M, Nakao K, Matsuda S, Mimoto S, Aoyama Y, Takeda T, Murata K, Akao M, Inada T, Eizawa H, Hyakuna E, Awano K, Shirotani M, Furukawa Y, Kadota K, Miyauchi K, Tanaka M, Noguchi Y, Nakamura S, Yasuda S, Miyazaki S, Daida H, Kimura K, Ikari Y, Hirayama H, Sumiyoshi T, Kimura T; ReACT Investigators. The ReACT Trial: Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial. JACC Cardiovasc Interv. 2017 Jan 23;10(2):109-117. doi: 10.1016/j.jcin.2016.10.018. Epub 2016 Dec 28.