Coronary Artery DiseasePhase 4NCT01765452
Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone
A Phase 4 study testing Closone and Plavix with Astrix in people with Coronary Artery Disease, run by HK inno.N Corporation at 7 sites 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
- 285 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Oct 2012to Aug 2013
- 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 a stable condition after Post-Percutaneous Coronary Artery Intervention over three months
- 20~86 years old
- Willing to adhere to protocol requirements and sign a informed consent form
Who cannot join
- Subject who did not undergo or failed Drug-Stent Implantation
- Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel)
- Subjects with a history of substance or alchol abuse
- Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS
- Subjects having Aspirin or other NSAIDs-induced Asthma or history
- Subjects with Severe hepatopathy(AST and ALT > 5 times the upper limit of normal)
Show all 13Show fewer
- Subjects with Severe nephropathy(Cr > 3 times the upper limit of normal)
- Subjects with hemorrhage like gastric ulcer, intracranial hemorrhage etc.
- Subjects with high risk of hemorrhage like blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding
- subjects who are pregnant, breastfeeding
- Subjects not using medically acceptable birth control
- Subjects who are unsuitable to take the Investigational product due to a medical/mental condition
- Subjects inherently having Galactose malobsorption, Lactase deficiency or Glucose-Galactose malobsorption
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Inje university haeundae paik hospital
Busan
Kosin university gospel hospital
Busan
Pusan national university hospital
Busan
Dongguk University Medical Center
Gyeonggi-do
Chungbuk national university hospital
Jungbuk
Seoul National University Hospital
Seoul
SNU Boramae Medical Center
Seoul
About this study
Official title: Multi-center, Randomized, Open Study for Comparison of Efficacy and Safety of Plavix With Astrix and Closone in Patients With Post-Percutaneous Coronary Artery Intervention
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
75mg/100mg, 8weeks, PO
Plavix with AstrixDrug
75mg, 100mg a day, 8weeks, PO
| Study group | Role | What they receive |
|---|---|---|
| Closone | Experimental | 75mg/100mg per day, 8weeks, PO Receives: Drug: Closone |
| Plavix with Astrix | Active comparator | 75mg per day, 8weeks, PO 100mg per day, 8weeks, 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 baselinine in P2Y12% inhibition at week 8
Measured: Baseline, week 8
Secondary outcomes (1)
Change from baseline in PRU, ARU at week 8
Measured: Baseline, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionAug 2013
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.
- More trials run by HK inno.N CorporationThe 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
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765452
- Sponsor's protocol ID
- CJ_CLO_401
- Status last verified
- May 2014
- First submitted
- 7 Jan 2013
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Open Study for Comparison of Efficacy and Safety of Plavix With Astrix and Closone in Patients With Post-Percutaneous Coronary Artery Intervention
- ClinicalTrials.gov ID
- NCT01765452
- Acronym / sponsor ID
- CJ_CLO_401
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 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, 8weeks, PO |
| Plavix with Astrix | Active comparator | Drug: Plavix with Astrix75mg per day, 8weeks, PO 100mg per day, 8weeks, 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 a stable condition after Post-Percutaneous Coronary Artery Intervention over three months
- 20~86 years old
- Willing to adhere to protocol requirements and sign a informed consent form
Key exclusion criteria (13 listed)
- Subject who did not undergo or failed Drug-Stent Implantation
- Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel)
- Subjects with a history of substance or alchol abuse
- Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS
- Subjects having Aspirin or other NSAIDs-induced Asthma or history
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 |
|---|---|---|
| Closone75mg/100mg, 8weeks, PO | Drug | Closone |
| Plavix with Astrix75mg, 100mg a day, 8weeks, PO | Drug | Plavix with Astrix |
Primary outcome
Change from baselinine in P2Y12% inhibition at week 8
Time frame: Baseline, week 8
1 secondary outcome
Change from baseline in PRU, ARU at week 8
Time frame: Baseline, week 8
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 12 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites 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 HK inno.N Corporation at 7 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 3 inclusion and 13 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 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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 baselinine in P2Y12% inhibition at week 8 (time frame: Baseline, week 8). 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 12 May 2014.