Coronary Artery DiseasePhase 4ReACTNCT01123291
Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
A Phase 4 study testing follow-up coronary angiography and Clinical follow-up in people with Coronary Artery Disease, run by Takeshi Morimoto at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- follow-up coronary angiography and Clinical follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteJapan
- Study dates
- May 2010to Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients received percutaneous coronary intervention
- Patients older than 20 years old
- Patients who will not scheduled any staged percutaneous coronary intervention
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Division of Cardiology, Kyoto University Hospital
Kyoto, Kyoto, 606-8507
About this study
Official title: Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- follow-up coronary angiography, Clinical follow-up
- Keywords
- follow-up coronary angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-up coronary angiographyProcedure or surgery
follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
Clinical follow-upProcedure or surgery
no routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| routine follow-up coronary angiography | Active comparator | routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention Receives: Procedure: follow-up coronary angiography |
| clinical follow-up | Active comparator | no routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention Receives: Procedure: Clinical follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
Measured: 4.8 years
Secondary outcomes (18)
death
death
Measured: 4.8 years
cardiac death
cardiac death
Measured: 4.8 years
myocardial infarction
myocardial infarction
Measured: 4.8 years
stent thrombosis
stent thrombosis defined bya Academic Reseach Consortium
Measured: 4.8 years
stroke
both ischemic and hemorrhagic stroke excluding transient ischemic attach
Measured: 4.8 years
bleeding complications
bleeding complications defined by GUSTO and TIMI
Measured: 4.8 years
any coronary revascularization
any coronary revascularization
Measured: 4.8 years
clinically-driven coronary revascularization
clinically-driven coronary revascularization
Measured: 4.8 years
clinically-driven target-lesion revascularization
clinically-driven target-lesion revascularization
Measured: 4.8 years
any target-lesion revascularization
any target-lesion revascularization
Measured: 4.8 years
coronary artery bypass grafting
coronary artery bypass grafting
Measured: 4.8 years
angina
angina
Measured: 4.8 years
renal function
estimate-glomerular filtration rate
Measured: 4.8 years
emergency hospitalization for acute coronary syndrome
emergency hospitalization for acute coronary syndrome
Measured: 4.8 years
hospitalization for congestive heart failure
hospitalization for congestive heart failure
Measured: 4.8 years
composite of cardiac death, myocardial infarction or acute coronary syndrome
composite of cardiac death, myocardial infarction or acute coronary syndrome
Measured: 4.8 years
follow-up coronary angiography
presence of follow-up coronary angiography
Measured: 4.8 years
clinically-driven follow-up coronary angiography
presence of clinically-driven follow-up coronary angiography
Measured: 4.8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeshi Morimoto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Takeshi Morimoto, Kyoto University, Graduate School of Medicine
- Investigators
- Takeshi Kimura, MD, Principal investigator, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123291
- Sponsor's protocol ID
- C406
- Acronym
- ReACT
- Status last verified
- Mar 2017
- First submitted
- 13 May 2010
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28040445
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
- ClinicalTrials.gov ID
- NCT01123291
- Acronym / sponsor ID
- ReACT / C406
- Conditions
- Coronary Artery Disease
- Keywords
- follow-up coronary angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Takeshi MorimotoUniversity, hospital or other
- Study start
- May 2010 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine follow-up coronary angiography | Active comparator | Procedure: follow-up coronary angiographyroutine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention |
| clinical follow-up | Active comparator | Procedure: Clinical follow-upno routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients received percutaneous coronary intervention
- Patients older than 20 years old
- Patients who will not scheduled any staged percutaneous coronary intervention
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow-up coronary angiographyfollow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention | Procedure or surgery | routine follow-up coronary angiography |
| Clinical follow-upno routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention | Procedure or surgery | clinical follow-up |
Primary outcome
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
Time frame: 4.8 years
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
18 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Derived from this study: PubMed 28040445Shiomi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Kimura, MD principal investigator
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing follow-up coronary angiography and Clinical follow-up in people with Coronary Artery Disease, run by Takeshi Morimoto at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure (time frame: 4.8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01123291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.