Acute Coronary SyndromePhase 4NCT02060786
Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)
A Phase 4 study testing generic clopidogrel (Plavitor® ) and original clopidogrel (Plavix® ) in people with Acute Coronary Syndrome, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- generic clopidogrel (Plavitor® ) and original clopidogrel (Plavix® )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Jun 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unstable angina or non-ST elevation myocardial infarction
- Patients who are planned coronary angiography
- Age >18 years, <75 years
- Patients who agree to the study protocol
Who cannot join
- Recent treatment with clopidogrel or pletaal or glycoprotein IIb/IIIa Rc antagonist
- Active bleeding (peptic ulcer, trauma or intra-cranial hemorrhage)
- Allergy to antiplatelet agent
- Bleeding diasthesis (blood coagulation disorders, uncontrolled severe hypertension, history of severe bleeding)
- History of drug abuse or alcohol abuse
- ST elevation myocardial infarction
Show all 12Show fewer
- Pregnancy
- Low platelet count (< 100,000 /L) or abnormal results of PT or PTT
- Liver disease ( bilirubin > 2 mg/dL, AST or ALT > 100 IU)
- Renal failure ( Cr > 2.0 mg/dL)
- Malignancy
- Proton pump inhibitor, NSAIDs statin (except atorvastatin)
Trial locations and contacts
1 site in 1 country.
About this study
This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.
- Conditions
- Acute Coronary Syndrome
- Being tested
- generic clopidogrel (Plavitor® ), original clopidogrel (Plavix® )
- Keywords
- Antiplatelet; clopidogrel; acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
generic clopidogrel (Plavitor® )Drug
original clopidogrel (Plavix® )Drug
| Study group | Role | What they receive |
|---|---|---|
| original Clopidogrel Bisulfate (Plavix®) | Active comparator | original Clopidogrel Bisulfate (Plavix®) 600mg loading Receives: Drug: original clopidogrel (Plavix® ) |
| generic Clopidogrel Bisulfate (Plavitor®) | Experimental | generic Clopidogrel Bisulfate (Plavitor®) 600mg loading Receives: Drug: generic clopidogrel (Plavitor® ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRU level at 2 hours after clopidogrel loading
Measured: 2 hours after clopidogrel loading
Secondary outcomes (5)
PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading
Measured: 4 -, 8- and 24 hours after clopidogrel loading
ARU level by VerifyNow before and 2 hours after loading
Measured: 2 hours after loading
Composite of death, myocardial infarction, target vessel revascularization
Measured: at 30 days
Stent thrombosis by Academic Research Consortium definition
Measured: at 30 days
Incidence of TIMI major bleedings
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startOct 2010
- Primary completionJun 2013
- Study completionJun 2013
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 Acute Coronary SyndromeStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A Pharmaceutical
- Responsible party
- Principal investigator, Seung-Jea Tahk, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060786
- Sponsor's protocol ID
- Plavitor
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Seo KW, Tahk SJ, Yang HM, Yoon MH, Shin JH, Choi SY, Lim HS, Hwang GS, Choi BJ, Park JS, Shin JS, Lee YH, Choi YW, Park SJ, Jin XJ. Point-of-care measurements of platelet inhibition after clopidogrel loading in patients with acute coronary syndrome: comparison of generic and branded clopidogrel bisulfate. Clin Ther. 2014 Nov 1;36(11):1588-94. doi: 10.1016/j.clinthera.2014.07.018. Epub 2014 Sep 15.
PubMed 25218311
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)
- ClinicalTrials.gov ID
- NCT02060786
- Acronym / sponsor ID
- Plavitor
- Conditions
- Acute Coronary Syndrome
- Keywords
- Antiplatelet; clopidogrel; acute coronary syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- Dong-A Pharmaceutical
- Study start
- Oct 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Feb 2014 (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.
This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| original Clopidogrel Bisulfate (Plavix®) | Active comparator | Drug: original clopidogrel (Plavix® )original Clopidogrel Bisulfate (Plavix®) 600mg loading |
| generic Clopidogrel Bisulfate (Plavitor®) | Experimental | Drug: generic clopidogrel (Plavitor® )generic Clopidogrel Bisulfate (Plavitor®) 600mg loading |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with unstable angina or non-ST elevation myocardial infarction
- Patients who are planned coronary angiography
- Age >18 years, <75 years
- Patients who agree to the study protocol
Key exclusion criteria (12 listed)
- Recent treatment with clopidogrel or pletaal or glycoprotein IIb/IIIa Rc antagonist
- Active bleeding (peptic ulcer, trauma or intra-cranial hemorrhage)
- Allergy to antiplatelet agent
- Bleeding diasthesis (blood coagulation disorders, uncontrolled severe hypertension, history of severe bleeding)
- History of drug abuse or alcohol abuse
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 |
|---|---|---|
| generic clopidogrel (Plavitor® ) | Drug | generic Clopidogrel Bisulfate (Plavitor®) |
| original clopidogrel (Plavix® ) | Drug | original Clopidogrel Bisulfate (Plavix®) |
Primary outcome
PRU level at 2 hours after clopidogrel loading
Time frame: 2 hours after clopidogrel loading
5 secondary outcomes
PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading
Time frame: 4 -, 8- and 24 hours after clopidogrel loading
ARU level by VerifyNow before and 2 hours after loading
Time frame: 2 hours after loading
Composite of death, myocardial infarction, target vessel revascularization
Time frame: at 30 days
Stent thrombosis by Academic Research Consortium definition
Time frame: at 30 days
Incidence of TIMI major bleedings
Time frame: at 30 days
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 Feb 2014.
- Derived from this study: PubMed 25218311Seo KW, Tahk SJ, Yang HM, Yoon MH, Shin JH, Choi SY, Lim HS, Hwang GS, Choi BJ, Park JS, Shin JS, Lee YH, Choi YW, Park SJ, Jin XJ. Point-of-care measurements of platelet inhibition after clopidogrel loading in patients with acute coronary syndrome: comparison of generic and branded clopidogrel bisulfate. Clin Ther. 2014 Nov 1;36(11):1588-94. doi: 10.1016/j.clinthera.2014.07.018. Epub 2014 Sep 15.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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 generic clopidogrel (Plavitor® ) and original clopidogrel (Plavix® ) in people with Acute Coronary Syndrome, run by Ajou University School of Medicine 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 4 inclusion and 12 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 Feb 2014. 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?
PRU level at 2 hours after clopidogrel loading (time frame: 2 hours after clopidogrel loading). 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 NCT02060786, 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 12 Feb 2014.