Coronary Artery DiseasePhase 4CILON-TNCT00776828
The Efficacy of CILostazol ON Ischemic Complications After DES Implantation
A Phase 4 study testing cilostazol in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Objectives : To evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent implantation Study Design : Prospective, open… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- cilostazol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 960 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2006to Jan 2010
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at leat 18 years of age
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of cilostazol and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant coronary artery stenosis (>50% by visual estimate)
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis>75%, evidence of myocardial ischemia does not have to be documented.
- Coronary lesions must be amenable for percutaneous coronary revascularization with drug eluting stents.
Who cannot join
- Subject who undergoes primary percutaneous coronary intervention due to acute ST elevation myocardial infarction
- Subject who has contraindication or allergy to anti-platelet agents (aspirin, clopidogrel or cilostazol)
- Subject who has thrombocytopenia (<120,000/uL)
- Subject who has liver cirrhosis (Child class B or C)
- Subject who is on the anticoagulation therapy
- Subject who has severe congestive heart failure (left ventricular ejection fraction <30%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of CILostazol-based Triple Anti-platelet Therapy ON Ischemic Complication After Drug-eluting stenT Implantation
Objectives :
- To evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent implantation
Read more
Study Design : Prospective, open label, two arm, randomized multicenter trial to test the superiority of cilostazol group compared with the control group. Patients will be randomized according to the use of cilostazol
Patient Enrollment: 960 patients enrolled at 5 centers in Korea
Patient Follow-up : Clinical follow-up will occur at 1, 3 and 6 months. Angiographic follow-up will be recommended to all patient at 6 months after index procedure.
Primary Endpoint
- Composite of adverse cardiovascular/cerebrovascular outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) within 6 months
Secondary Endpoint
- All cause of death, stent thrombosis, and each component of primary endpoint at six months
- PRU level measured at discharge after the index procedure and after six months
Safety Endpoint
- Bleeding complications according to TIMI criteria
- The incidence of drug discontinuation
- Heart rate
Read the detailed description
Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed
- Conditions
- Coronary Artery Disease
- Being tested
- cilostazol
- Keywords
- cilostazol, clopidogrel, statin, drug-eluting stent
- 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.
cilostazolDrug
Also called Pletaal (Otsuka pharmaceutical)
Pletaal (Otsuka Pharm.) 100mg bid for six months
| Study group | Role | What they receive |
|---|---|---|
| TAT | Active comparator | triple antiplatelet therapy : aspirin, clopidogrel and cilostazol Receives: Drug: cilostazol |
| DAT | Placebo comparator | dual antiplatelet therapy : aspirin, clopidogrel Receives: Drug: cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of adverse cardiovascular outcomes
composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization
Measured: six months
Secondary outcomes (5)
all cause of death
Measured: six months
stent thrombosis
Measured: six months
each component of primary endpoint
Measured: six months
PRU level
Measured: at discharge after the index procedure
PRU level
Measured: six months after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startNov 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hyo-Soo Kim, MD,PhD, Principal investigator, Seoul National University HospitalIn-Ho Chae, MD, PhD, Study chair, Seoul National University Bundang HospitalJang-Ho Bae, MD, PhD, Study chair, Gonyang University HospitalMyung-Chan Cho, MD, PhD, Study chair, Chungbuk National University HospitalSeung-Woon Rha, MD, PhD, Study chair, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776828
- Sponsor's protocol ID
- CILON-T
- Acronym
- CILON-T
- Status last verified
- Dec 2013
- First submitted
- 18 Oct 2008
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PubMed 35224730Suh JW, Lee SP, Park KW, Lee HY, Kang HJ, Koo BK, Cho YS, Youn TJ, Chae IH, Choi DJ, Rha SW, Bae JH, Kwon TG, Bae JW, Cho MC, Kim HS. Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: results of the CILON-T (influence of CILostazol-based triple antiplatelet therapy ON ischemic complication after drug-eluting stenT implantation) trial. J Am Coll Cardiol. 2011 Jan 18;57(3):280-9. doi: 10.1016/j.jacc.2010.08.631.
PubMed 21232664Lee SP, Suh JW, Park KW, Lee HY, Kang HJ, Koo BK, Chae IH, Choi DJ, Rha SW, Bae JW, Cho MC, Kwon TG, Bae JH, Kim HS; CILON-T investigators. Study design and rationale of 'Influence of Cilostazol-based triple anti-platelet therapy on ischemic complication after drug-eluting stent implantation (CILON-T)' study: A multicenter randomized trial evaluating the efficacy of Cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease. Trials. 2010 Aug 24;11:87. doi: 10.1186/1745-6215-11-87.
PubMed 20735821
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of CILostazol-based Triple Anti-platelet Therapy ON Ischemic Complication After Drug-eluting stenT Implantation
- ClinicalTrials.gov ID
- NCT00776828
- Acronym / sponsor ID
- CILON-T / CILON-T
- Conditions
- Coronary Artery Disease
- Keywords
- cilostazol, clopidogrel, statin, drug-eluting stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 21 Oct 2008 (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.
Objectives :
- To evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent implantation
Study Design : Prospective, open label, two arm, randomized multicenter trial to test the superiority of cilostazol group compared with the control group. Patients will be randomized according to the use of cilostazol
Patient Enrollment: 960 patients enrolled at 5 centers in Korea
Patient Follow-up : Clinical follow-up will occur at 1, 3 and 6 months. Angiographic follow-up will be recommended to all patient at 6 months after index procedure.
Primary Endpoint
- Composite of adverse cardiovascular/cerebrovascular outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) within 6 months
Secondary Endpoint
- All cause of death, stent thrombosis, and each component of primary endpoint at six months
- PRU level measured at discharge after the index procedure and after six months
Safety Endpoint
- Bleeding complications according to TIMI criteria
- The incidence of drug discontinuation
- Heart rate
Detailed description
Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAT | Active comparator | Drug: cilostazoltriple antiplatelet therapy : aspirin, clopidogrel and cilostazol |
| DAT | Placebo comparator | Drug: cilostazoldual antiplatelet therapy : aspirin, clopidogrel |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must be at leat 18 years of age
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of cilostazol and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant coronary artery stenosis (>50% by visual estimate)
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis>75%, evidence of myocardial ischemia does not have to be documented.
- Coronary lesions must be amenable for percutaneous coronary revascularization with drug eluting stents.
Key exclusion criteria (6 listed)
- Subject who undergoes primary percutaneous coronary intervention due to acute ST elevation myocardial infarction
- Subject who has contraindication or allergy to anti-platelet agents (aspirin, clopidogrel or cilostazol)
- Subject who has thrombocytopenia (<120,000/uL)
- Subject who has liver cirrhosis (Child class B or C)
- Subject who is on the anticoagulation therapy
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 |
|---|---|---|
| cilostazolAlso: Pletaal (Otsuka pharmaceutical)Pletaal (Otsuka Pharm.) 100mg bid for six months | Drug | DAT, TAT |
Primary outcome
Composite of adverse cardiovascular outcomes
Time frame: six months
composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization
5 secondary outcomes
all cause of death
Time frame: six months
stent thrombosis
Time frame: six months
each component of primary endpoint
Time frame: six months
PRU level
Time frame: at discharge after the index procedure
PRU level
Time frame: six months after the index procedure
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 17 Dec 2013.
- Derived from this study: PubMed 35224730Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
- Derived from this study: PubMed 21232664Suh JW, Lee SP, Park KW, Lee HY, Kang HJ, Koo BK, Cho YS, Youn TJ, Chae IH, Choi DJ, Rha SW, Bae JH, Kwon TG, Bae JW, Cho MC, Kim HS. Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: results of the CILON-T (influence of CILostazol-based triple antiplatelet therapy ON ischemic complication after drug-eluting stenT implantation) trial. J Am Coll Cardiol. 2011 Jan 18;57(3):280-9. doi: 10.1016/j.jacc.2010.08.631.
- Derived from this study: PubMed 20735821Lee SP, Suh JW, Park KW, Lee HY, Kang HJ, Koo BK, Chae IH, Choi DJ, Rha SW, Bae JW, Cho MC, Kwon TG, Bae JH, Kim HS; CILON-T investigators. Study design and rationale of 'Influence of Cilostazol-based triple anti-platelet therapy on ischemic complication after drug-eluting stent implantation (CILON-T)' study: A multicenter randomized trial evaluating the efficacy of Cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease. Trials. 2010 Aug 24;11:87. doi: 10.1186/1745-6215-11-87.
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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.
Hyo-Soo Kim, MD,PhD principal investigator
Seoul National University Hospital
In-Ho Chae, MD, PhD study chair
Seoul National University Bundang Hospital
Jang-Ho Bae, MD, PhD study chair
Gonyang University Hospital
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 cilostazol in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site 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 5 inclusion and 6 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 17 Dec 2013. 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 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. Some participants in this study may receive a placebo. 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?
Composite of adverse cardiovascular outcomes (time frame: six months). 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 NCT00776828, which also lists 3 linked publications.
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 17 Dec 2013.