Coronary Artery DiseasePhase 4NCT01763749
Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin
A Phase 4 study testing Closone and Plavix with Astrix in people with Coronary Artery Disease, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Closone and Plavix with Astrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Oct 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects under condition after Post-Percutaneous Coronary Artery Intervention over twelve months
- 20~85 years old
- Willing to adhere to protocol requirements and sign a informed consent form
Who cannot join
- Subject who did not undergo or failed Stent Implantation
- Subjects who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
- Subjects with a history of hypersensitivity to Clopidogrel, Aspirin
- Subjects with uncontrolled severe hypertension
- Subjects with high risk of hemorrhage like blood coagulation disorders
- :gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage
Show all 11Show fewer
- Subjects with intractable arrhythmia, intracranial hemorrhage
- Subjects with Severe cardiomyopathy (New York Heart Association(NYHA) Class Ⅳ)
- Subjects with Severe hepatopathy(AST and ALT > 10 times the upper limit of normal)
- Subjects who are pregnant, breastfeeding and not using medically acceptable birth control
- Subjects considered as unsuitable based on medical judgement by investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital
Seoul, Seochogu, 137-701
About this study
Official title: Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin in Korean Patients With Coronary Artery Disease (a Single-center, Randomized, Open-label Clinical Trial)
The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.
- Conditions
- Coronary Artery Disease
- Being tested
- Closone, Plavix with Astrix
- 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.
ClosoneDrug
Closone 75mg/100mg, 4weeks, PO
Plavix with AstrixDrug
Plavix 75mg with Astrix 100mg, 4weeks, PO
| Study group | Role | What they receive |
|---|---|---|
| Closone | Experimental | 75mg/100mg per day, 4weeks, PO Receives: Drug: Closone |
| Plavix with Astrix | Active comparator | Plavix 75mg with Astrix 100mg, 4weeks, PO Receives: Drug: Plavix with Astrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in P2Y12% inhibition at week 4
Measured: Baseline, week 4
Secondary outcomes (3)
Change from baseline in VerifyNow P2Y12 reaction unit at week 4
PRU : VerifyNow P2Y12 reaction unit
Measured: Baseline, week 4
Change from baseline in VerifyNow Aspirin Reaction Unit at week 4
ARU : VerifyNow Aspirin Reaction Unit
Measured: Baseline, week 4
Change from baseline in maxymal platelet aggregation at week 4
MPA : maxymal platelet aggregation
Measured: Baseline, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiyuk Chang, Seoul St. Mary's Hospital
- Investigators
- Ki-Bae Seung, MD, PhD, Principal investigator, Cardiovascular center and Cardiology Division, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763749
- Sponsor's protocol ID
- CLO_1201
- Status last verified
- Feb 2015
- First submitted
- 7 Jan 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin in Korean Patients With Coronary Artery Disease (a Single-center, Randomized, Open-label Clinical Trial)
- ClinicalTrials.gov ID
- NCT01763749
- Acronym / sponsor ID
- CLO_1201
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Jan 2013 (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 Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closone | Experimental | Drug: Closone75mg/100mg per day, 4weeks, PO |
| Plavix with Astrix | Active comparator | Drug: Plavix with AstrixPlavix 75mg with Astrix 100mg, 4weeks, PO |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects under condition after Post-Percutaneous Coronary Artery Intervention over twelve months
- 20~85 years old
- Willing to adhere to protocol requirements and sign a informed consent form
Key exclusion criteria (11 listed)
- Subject who did not undergo or failed Stent Implantation
- Subjects who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
- Subjects with a history of hypersensitivity to Clopidogrel, Aspirin
- Subjects with uncontrolled severe hypertension
- Subjects with high risk of hemorrhage like blood coagulation disorders
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 |
|---|---|---|
| ClosoneClosone 75mg/100mg, 4weeks, PO | Drug | Closone |
| Plavix with AstrixPlavix 75mg with Astrix 100mg, 4weeks, PO | Drug | Plavix with Astrix |
Primary outcome
Change from baseline in P2Y12% inhibition at week 4
Time frame: Baseline, week 4
3 secondary outcomes
Change from baseline in VerifyNow P2Y12 reaction unit at week 4
Time frame: Baseline, week 4
Change from baseline in VerifyNow Aspirin Reaction Unit at week 4
Time frame: Baseline, week 4
Change from baseline in maxymal platelet aggregation at week 4
Time frame: Baseline, week 4
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 3 Mar 2015.
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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, MD, PhD principal investigator
Cardiovascular center and Cardiology Division, Seoul St. Mary's 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 Closone and Plavix with Astrix in people with Coronary Artery Disease, run by Seoul St. Mary's 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 3 inclusion and 11 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 3 Mar 2015. 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. 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?
Change from baseline in P2Y12% inhibition at week 4 (time frame: Baseline, week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2015.