Drug Eluting StentCOACTNCT01239914
CathOlic Medical Center percutAneous Coronary inTervention Registry (COACT)
An observational study of Drug Eluting Stent and Coronary Artery Disease, run by The Catholic University of Korea at 8 sites in South Korea.
Trial summary
COACT registry is a multicenter registry of consecutive patients undergoing coronary stent implantation at 8 centers in the Catholic University of Korea to evaluate the real world management of patients with coronary artery disease and to assess their in-hospital, medium and long-term outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Eluting Stent, Coronary Artery Disease, Polymorphism
- How many people
- 11,719 participants
- Where
- 8 sitesSouth Korea
- Study dates
- Jan 2005to Dec 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all comers who admitted cardiovascular center for coronary stent implantation
Who may be able to join
- all consecutive patients who underwent percutaneous coronary intervention
- written informed consent for the DNA and serum databank
Who cannot join
- patients who did not agreed to participate
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Bucheon St.Mary Hospital
Bucheon-si, Gyeonggido
Daejeon St.Mary's Hospital
Daejeon
Incheon St.Mary's Hospital
Incheon
Seoul St.Mary's Hospital
Seoul, 137-701
St.Paul's Hospital
Seoul
Yeouido St.Mary Hospital
Seoul
St.Vincent's Hospital
Suwon, Gyeonggido
Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggido
About this study
COACT registry is a multicenter registry of consecutive patients undergoing coronary stent implantation at 8 centers in the Catholic University of Korea to evaluate the real world management of patients with coronary artery disease and to assess their in-hospital, medium and long-term outcomes.
- Keywords
- drug eluting stent, coronary artery disease, Korean registry
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
All causes mortality
Measured: 6month, each year
Cardiac death
Measured: 6 month, each year
Myocardial infarction
Measured: 6 month, each year
target lesion revascularization
Measured: 6 month, each year
target vessel revascularization
Measured: 6 month, each year
Secondary outcomes (4)
non target vessel revascularization
Measured: 6 month, each year
Stent thrombosis
Measured: 6 month, each year
Serum databank for evaluation of biomarkers outcomes
Measured: 6 month, each year
Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes
Measured: 6 month, each year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startJan 2005
- Primary completionDec 2019
- Study completionDec 2019
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 Drug Eluting StentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,719 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Yeouido St. Mary's Hospital, Bucheon St. Mary's Hospital, St.Paul's Hospital, Korea, Incheon St.Mary's Hospital, Saint Vincent's Hospital, Korea, Daejeon St. Mary's hospital
- Responsible party
- Principal investigator, Kiyuk Chang, MD,PhD, The Catholic University of Korea
- Investigators
- Ki-Bae Seung, M.D.,PhD, Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239914
- Sponsor's protocol ID
- COACT
- Acronym
- COACT
- Status last verified
- Sep 2022
- First submitted
- 12 Nov 2010
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim HS, Chang K, Koh YS, Park MW, Choi YS, Park CS, Oh M, Kim EY, Shon JH, Shin JG, Seung KB. CYP2C19 poor metabolizer is associated with clinical outcome of clopidogrel therapy in acute myocardial infarction but not stable angina. Circ Cardiovasc Genet. 2013 Oct;6(5):514-21. doi: 10.1161/CIRCGENETICS.113.000109. Epub 2013 Sep 9.
PubMed 24019397
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CathOlic Medical Center percutAneous Coronary inTervention Registry (COACT)
- ClinicalTrials.gov ID
- NCT01239914
- Acronym / sponsor ID
- COACT / COACT
- Keywords
- drug eluting stent, coronary artery disease, Korean registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,719 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Yeouido St. Mary's Hospital, Bucheon St. Mary's Hospital, St.Paul's Hospital, Korea, Incheon St.Mary's Hospital, Saint Vincent's Hospital, Korea, Daejeon St. Mary's hospital
- Study start
- Jan 2005
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 15 Nov 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.
COACT registry is a multicenter registry of consecutive patients undergoing coronary stent implantation at 8 centers in the Catholic University of Korea to evaluate the real world management of patients with coronary artery disease and to assess their in-hospital, medium and long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all comers who admitted cardiovascular center for coronary stent implantation
Key inclusion criteria (2 listed)
- all consecutive patients who underwent percutaneous coronary intervention
- written informed consent for the DNA and serum databank
Key exclusion criteria (1 listed)
- patients who did not agreed to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All causes mortality
Time frame: 6month, each year
Cardiac death
Time frame: 6 month, each year
Myocardial infarction
Time frame: 6 month, each year
target lesion revascularization
Time frame: 6 month, each year
target vessel revascularization
Time frame: 6 month, each year
4 secondary outcomes
non target vessel revascularization
Time frame: 6 month, each year
Stent thrombosis
Time frame: 6 month, each year
Serum databank for evaluation of biomarkers outcomes
Time frame: 6 month, each year
Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes
Time frame: 6 month, each year
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 7 Sep 2022.
- Derived from this study: PubMed 24019397Kim HS, Chang K, Koh YS, Park MW, Choi YS, Park CS, Oh M, Kim EY, Shon JH, Shin JG, Seung KB. CYP2C19 poor metabolizer is associated with clinical outcome of clopidogrel therapy in acute myocardial infarction but not stable angina. Circ Cardiovasc Genet. 2013 Oct;6(5):514-21. doi: 10.1161/CIRCGENETICS.113.000109. Epub 2013 Sep 9.
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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.
Ki-Bae Seung, M.D.,PhD study chair
Seoul St. Mary's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Eluting Stent and Coronary Artery Disease, run by The Catholic University of Korea at 8 sites in South Korea.
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 2 inclusion and 1 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. 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.
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?
All causes mortality (time frame: 6month, each year). The study lists 5 primary outcomes in all. 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 NCT01239914, 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 7 Sep 2022.