Coronary Artery DiseasePhase 4NCT01584791
Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
A Phase 4 study testing clopidogrel napadisilate + aspirin and clopidogrel bisulfate + aspirin in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of the current study is to compare the antiplatelet efficacy and safety of clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients after coronary stent implantation. 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?
- clopidogrel napadisilate + aspirin and clopidogrel bisulfate + aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Feb 2012
- 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
- Korean men and women between the age of 20 and 85
- Patients who were diagnosed as having CAD
- Patients who were planned to undergo PCI
Who cannot join
- Patients who were not treated with PCI or intended to treat with PCI but failed
- Patients who were were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days
- Patients who were had a history of alcohol abuse or intoxication; (4) had hypersensitivity to clopidogrel or aspirin
- Patients who were had hypersensitivity to clopidogrel or aspirin
- Patients who were had abnormal laboratory results indicative of liver disease
- Patients who were had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding
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- Patients who were were pregnant, breastfeeding, or not using effective methods of contraception
- Patients who were had other contraindication to study drug
- Patients who were had participated in another clinical study within 4 weeks prior to the start of this study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current study is to compare the antiplatelet efficacy and safety of clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients after coronary stent implantation.
- Conditions
- Coronary Artery Disease
- Being tested
- clopidogrel napadisilate + aspirin, clopidogrel bisulfate + aspirin
- Keywords
- CAD, PCI, Percutaneous Coronary Intervention
- 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.
clopidogrel napadisilate + aspirinDrug
clopidogrel napadisilate 75mg + aspirin 100mg
clopidogrel bisulfate + aspirinDrug
clopidogrel bisulfate 75mg + aspirin 100mg
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel napadisilate + aspirin | Experimental | Not described Receives: Drug: clopidogrel napadisilate + aspirin |
| clopidogrel bisulfate + aspirin | Active comparator | Not described Receives: Drug: clopidogrel bisulfate + aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of P2Y12 receptor inhibition
Measured: 4 weeks
Secondary outcomes (1)
Adverse events after study medication
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startOct 2010
- Primary completionFeb 2012
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 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanmi Pharmaceutical co., ltd.
- Responsible party
- Principal investigator, Hyo-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584791
- Sponsor's protocol ID
- KOPIDO STENT
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2012
- Last updated
- 25 Apr 2012
- Results posted
- No
Publications
Park JB, Koo BK, Choi WG, Kim SY, Park J, Kwan J, Park CG, Kim HS. Comparison of antiplatelet efficacy and tolerability of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients after percutaneous coronary intervention: a prospective, multicenter, randomized, open-label, phase IV, noninferiority trial. Clin Ther. 2013 Jan;35(1):28-37.e4. doi: 10.1016/j.clinthera.2012.12.004.
PubMed 23328268
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
- ClinicalTrials.gov ID
- NCT01584791
- Acronym / sponsor ID
- KOPIDO STENT
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, PCI, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Hanmi Pharmaceutical co., ltd.
- Study start
- Oct 2010
- Primary completion
- Feb 2012 (actual)
- First posted
- 25 Apr 2012 (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 the current study is to compare the antiplatelet efficacy and safety of clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients after coronary stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clopidogrel napadisilate + aspirin | Experimental | Drug: clopidogrel napadisilate + aspirin |
| clopidogrel bisulfate + aspirin | Active comparator | Drug: clopidogrel bisulfate + aspirin |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Korean men and women between the age of 20 and 85
- Patients who were diagnosed as having CAD
- Patients who were planned to undergo PCI
Key exclusion criteria (9 listed)
- Patients who were not treated with PCI or intended to treat with PCI but failed
- Patients who were were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days
- Patients who were had a history of alcohol abuse or intoxication; (4) had hypersensitivity to clopidogrel or aspirin
- Patients who were had hypersensitivity to clopidogrel or aspirin
- Patients who were had abnormal laboratory results indicative of liver disease
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 |
|---|---|---|
| clopidogrel napadisilate + aspirinclopidogrel napadisilate 75mg + aspirin 100mg | Drug | clopidogrel napadisilate + aspirin |
| clopidogrel bisulfate + aspirinclopidogrel bisulfate 75mg + aspirin 100mg | Drug | clopidogrel bisulfate + aspirin |
Primary outcome
The percentage of P2Y12 receptor inhibition
Time frame: 4 weeks
1 secondary outcome
Adverse events after study medication
Time frame: 4 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 25 Apr 2012.
- Derived from this study: PubMed 23328268Park JB, Koo BK, Choi WG, Kim SY, Park J, Kwan J, Park CG, Kim HS. Comparison of antiplatelet efficacy and tolerability of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients after percutaneous coronary intervention: a prospective, multicenter, randomized, open-label, phase IV, noninferiority trial. Clin Ther. 2013 Jan;35(1):28-37.e4. doi: 10.1016/j.clinthera.2012.12.004.
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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.
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 clopidogrel napadisilate + aspirin and clopidogrel bisulfate + aspirin 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 3 inclusion and 9 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 25 Apr 2012. 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?
The percentage of P2Y12 receptor inhibition (time frame: 4 weeks). 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 NCT01584791, 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 25 Apr 2012.