ANEURYSM CORONARY ARTERYPhase 4NCT02410083
Trial to Assess the Efficacy of Combination Formula of Aspirin Plus Clopidogrel in Patients With Coronary Stent
A Phase 4 study testing Clopirin 1, Clopidogrel-Aspirin(co-administration) 1 and Clopirin 2 in people with ANEURYSM CORONARY ARTERY, run by Jeil Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study in to evaluate efficacy and tolerability of Clopirin and clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery intervention. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- ANEURYSM CORONARY ARTERY
- What is being tested?
- Clopirin 1, Clopidogrel-Aspirin(co-administration) 1 and Clopirin 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Dec 2015
- 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
- Over 3 months, the patient who were the administration of aspirin or the co-administration of clopidogrel-aspirin coronary artery patients after treated with Percutaneous Coronary Intervention(PCI) that have safety progress.
- Korean men and women between the age of 20 and 85
- Patients who understand the study requirements, are willing to comply with all study procedures and have provided written informed consent.
Who cannot join
- Patients who were not treated with PCI or intended to treat with PCI but failed.
- Patients who were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days.
- Patients who had a history of alcohol abuse or intoxication.
- Patients who had hypersensitivity to clopidogrel or aspirin.
- Patients who had severe hepatic dysfunction aspartate aminotransferase(AST) or alanine aminotransferase(ALT) > 3 times upper normal reference values.
- Patients who had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding - surgery within 48hr, platelet counts below 50,000/mm3 in laboratory tests.
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- Patients who were pregnant, breastfeeding.
- Patients who were not using effective methods of contraception. (proper contraception : hormonal contraception, condom, intrauterine device, spermicide)
- Patients who medically, psychologically had investigational product administration's prohibition.
- Patients who were not participated in this clinical trial decided by other investigators.
About this study
Official title: Multicenter, Randomized, Open Study, Investigator-initiated Trial for Comparison of Eight Weeks Efficacy and Tolerability of Clopirin and Clopidogrel With Aspirin in Korean Patients With Post-Percutaneous Coronary Artery Intervention
The purpose of this study in to evaluate efficacy and tolerability of Clopirin and clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery intervention.
- Conditions
- ANEURYSM CORONARY ARTERY
- Being tested
- Clopirin 1, Clopidogrel-Aspirin(co-administration) 1, Clopirin 2, Clopidogrel-Aspirin(co-administration) 2
- Medical subject headings
- Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopirin 1Drug
Clopidogrel-Aspirin(co-administration) 1Drug
Clopirin 2Drug
Clopidogrel-Aspirin(co-administration) 2Drug
| Study group | Role | What they receive |
|---|---|---|
| Clopirin 1 | Experimental | Clopirin single-administration. Before this clinical trial Clopidogrel/Aspirin co-administration. Receives: Drug: Clopirin 1 |
| Clopidogrel/Aspirin co-administration 1 | Active comparator | Clopidogrel-aspirin co-administration. Before this clinical trialClopidogrel/Aspirin co-administration. Receives: Drug: Clopidogrel-Aspirin(co-administration) 1 |
| Clopirin 2 | Experimental | Clopirin single-administration. Before this clinical trial Aspirin single-administration. Receives: Drug: Clopirin 2 |
| Clopidogrel/Aspirin co-administration 2 | Active comparator | Clopidogrel-aspirin-co-administration. Before this clinical trial Aspirin single-administration. Receives: Drug: Clopidogrel-Aspirin(co-administration) 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
% inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU
Measured: 8 weeks
Secondary outcomes (2)
△ PRU = Post treatment PRU - Pre treatment PRU
Measured: 8 weeks
△ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANEURYSM CORONARY ARTERYStudies 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
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo-soo Kim, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410083
- Sponsor's protocol ID
- JP_CLN_01
- Status last verified
- Mar 2015
- First submitted
- 19 Mar 2015
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open Study, Investigator-initiated Trial for Comparison of Eight Weeks Efficacy and Tolerability of Clopirin and Clopidogrel With Aspirin in Korean Patients With Post-Percutaneous Coronary Artery Intervention
- ClinicalTrials.gov ID
- NCT02410083
- Acronym / sponsor ID
- JP_CLN_01
- Conditions
- ANEURYSM CORONARY ARTERY
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Apr 2015 (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 in to evaluate efficacy and tolerability of Clopirin and clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clopirin 1 | Experimental | Drug: Clopirin 1Clopirin single-administration. Before this clinical trial Clopidogrel/Aspirin co-administration. |
| Clopidogrel/Aspirin co-administration 1 | Active comparator | Drug: Clopidogrel-Aspirin(co-administration) 1Clopidogrel-aspirin co-administration. Before this clinical trialClopidogrel/Aspirin co-administration. |
| Clopirin 2 | Experimental | Drug: Clopirin 2Clopirin single-administration. Before this clinical trial Aspirin single-administration. |
| Clopidogrel/Aspirin co-administration 2 | Active comparator | Drug: Clopidogrel-Aspirin(co-administration) 2Clopidogrel-aspirin-co-administration. Before this clinical trial Aspirin single-administration. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 3 months, the patient who were the administration of aspirin or the co-administration of clopidogrel-aspirin coronary artery patients after treated with Percutaneous Coronary Intervention(PCI) that have safety progress.
- Korean men and women between the age of 20 and 85
- Patients who understand the study requirements, are willing to comply with all study procedures and have provided written informed consent.
Key exclusion criteria (10 listed)
- Patients who were not treated with PCI or intended to treat with PCI but failed.
- Patients who were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days.
- Patients who had a history of alcohol abuse or intoxication.
- Patients who had hypersensitivity to clopidogrel or aspirin.
- Patients who had severe hepatic dysfunction aspartate aminotransferase(AST) or alanine aminotransferase(ALT) > 3 times upper normal reference values.
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 |
|---|---|---|
| Clopirin 1 | Drug | Clopirin 1 |
| Clopidogrel-Aspirin(co-administration) 1 | Drug | Clopidogrel/Aspirin co-administration 1 |
| Clopirin 2 | Drug | Clopirin 2 |
| Clopidogrel-Aspirin(co-administration) 2 | Drug | Clopidogrel/Aspirin co-administration 2 |
Primary outcome
% inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU
Time frame: 8 weeks
2 secondary outcomes
△ PRU = Post treatment PRU - Pre treatment PRU
Time frame: 8 weeks
△ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU
Time frame: 8 weeks
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 14 Mar 2017.
- Individual participant dataSharing planned: No
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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, Professor principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopirin 1, Clopidogrel-Aspirin(co-administration) 1 and Clopirin 2 in people with ANEURYSM CORONARY ARTERY, run by Jeil Pharmaceutical Co., Ltd..
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 10 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
% inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU (time frame: 8 weeks). 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 14 Mar 2017.