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

NCT ID: NCT01123291

Last Updated: 2017-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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routine follow-up coronary angiography

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

Group Type ACTIVE_COMPARATOR

follow-up coronary angiography

Intervention Type PROCEDURE

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

clinical follow-up

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

Group Type ACTIVE_COMPARATOR

Clinical follow-up

Intervention Type PROCEDURE

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

Interventions

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follow-up coronary angiography

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

Intervention Type PROCEDURE

Clinical follow-up

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeshi Morimoto

OTHER

Sponsor Role lead

Responsible Party

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Takeshi Morimoto

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Takeshi Kimura, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Locations

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Division of Cardiology, Kyoto University Hospital

Kyoto, Kyoto, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 28040445 (View on PubMed)

Other Identifiers

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C406

Identifier Type: -

Identifier Source: org_study_id

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