Coronary Artery DiseasePhase 4CHOICENCT01069302
Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
A Phase 4 study testing Clopidogrel in people with Coronary Artery Disease, run by Takeshi Morimoto at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for percutaneous coronary intervention due to ischemic heart disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2010to Dec 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for percutaneous coronary intervention due to ischemic heart disease
- Patients taking aspirin 81-100mg at least 1 week.
Who cannot join
- Patients with ST elevation myocardial infarction
- Patients have contraindication of aspirin or clopidogrel
- Patients taking warfarin
- Patients received thrombolytic therapy within 2 weeks
- Patients taking anti-platelet agents except aspirin within 1 month
- Patients taking corticosteroid.
- Patients taking proton pump inhibitor
Trial locations and contacts
1 site in 1 country.
Japan1 site
Division of Cardiology, Kyoto University Hospital
Kyoto, Kyoto, 606-8507
About this study
The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for percutaneous coronary intervention due to ischemic heart disease.
Read the detailed description
Dual antiplatelet therapy of aspirin and thienopyridine is used to prevent stent thrombosis after percutaneous coronary intervention (PCI). Clopidogrel is the most popular thienopyridine. Following the 300mg clopidogrel loading dose (LD) at first day, patients take 75mg maintenance dose (MD) to inhibit platelet aggregation after coronary stent implantation. 600mg high LD inhibit platelet aggregation more rapidly and strongly than standard LD and prevent thrombotic event around the PCI. Similarly high MD inhibit platelet aggregation more strongly. Interindividual variability of clopidogrel anti-platelet effect has been reported. In Japanese, there are many non or hyporesponders to clopidogrel compared to the Western population. The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for PCI due to ischemic heart disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel
- Keywords
- Coronary artery disease
- 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.
ClopidogrelDrug
Clopidogrel loading 600mg and maintenance 150mg for 7days
ClopidogrelDrug
Clopidogrel loading 600mg and maintenance 75mg for 7days
ClopidogrelDrug
Clopidogrel loading 300mg and maintenance 150mg for 7days
ClopidogrelDrug
Clopidogrel loading 300mg and maintenance 75mg for 7days
| Study group | Role | What they receive |
|---|---|---|
| High loading and high maintenance | Active comparator | Clopidogrel loading 600mg and maintenance 150mg for 7days Receives: Drug: Clopidogrel |
| High loading and low maintenance | Active comparator | Clopidogrel loading 600mg and maintenance 75mg for 7days Receives: Drug: Clopidogrel |
| Low loading and high maintenance | Active comparator | Clopidogrel loading 300mg and maintenance 150mg for 7days Receives: Drug: Clopidogrel |
| Low loading and low maintenance | Active comparator | Clopidogrel loading 300mg and maintenance 75mg for 7days Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition of platelet aggregation 24 hours after loading
Measured: 24 hours
Secondary outcomes (9)
Inhibition of platelet aggregation 7 days after loading
Measured: 7 days
Inhibition of platelet aggregation 28 days after loading
Measured: 28 days
all cause death
Measured: 1 year
cardiac death
Measured: 1 year
myocardial infarction
Measured: 1 year
stent thrombosis (Academic Research Consortium definition)
Measured: 1 year
acute hemorrhagic or ischemic stroke excluding transient ischemic attack
Measured: 1 year
bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition)
Measured: 1 year
composite of cardiac death, myocardial infarction and stroke
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2011
- Study completionDec 2011
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeshi Morimoto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Takeshi Morimoto, Kyoto University, Graduate School of Medicine
- Investigators
- Takeshi Kimura, MD, Principal investigator, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069302
- Sponsor's protocol ID
- C369
- Acronym
- CHOICE
- Status last verified
- Jan 2016
- First submitted
- 16 Feb 2010
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
- ClinicalTrials.gov ID
- NCT01069302
- Acronym / sponsor ID
- CHOICE / C369
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Takeshi MorimotoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Feb 2010 (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 is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for percutaneous coronary intervention due to ischemic heart disease.
Detailed description
Dual antiplatelet therapy of aspirin and thienopyridine is used to prevent stent thrombosis after percutaneous coronary intervention (PCI). Clopidogrel is the most popular thienopyridine. Following the 300mg clopidogrel loading dose (LD) at first day, patients take 75mg maintenance dose (MD) to inhibit platelet aggregation after coronary stent implantation. 600mg high LD inhibit platelet aggregation more rapidly and strongly than standard LD and prevent thrombotic event around the PCI. Similarly high MD inhibit platelet aggregation more strongly. Interindividual variability of clopidogrel anti-platelet effect has been reported. In Japanese, there are many non or hyporesponders to clopidogrel compared to the Western population. The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for PCI due to ischemic heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High loading and high maintenance | Active comparator | Drug: ClopidogrelClopidogrel loading 600mg and maintenance 150mg for 7days |
| High loading and low maintenance | Active comparator | Drug: ClopidogrelClopidogrel loading 600mg and maintenance 75mg for 7days |
| Low loading and high maintenance | Active comparator | Drug: ClopidogrelClopidogrel loading 300mg and maintenance 150mg for 7days |
| Low loading and low maintenance | Active comparator | Drug: ClopidogrelClopidogrel loading 300mg and maintenance 75mg for 7days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for percutaneous coronary intervention due to ischemic heart disease
- Patients taking aspirin 81-100mg at least 1 week.
Key exclusion criteria (7 listed)
- Patients with ST elevation myocardial infarction
- Patients have contraindication of aspirin or clopidogrel
- Patients taking warfarin
- Patients received thrombolytic therapy within 2 weeks
- Patients taking anti-platelet agents except aspirin within 1 month
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 |
|---|---|---|
| ClopidogrelClopidogrel loading 600mg and maintenance 150mg for 7days | Drug | High loading and high maintenance |
| ClopidogrelClopidogrel loading 600mg and maintenance 75mg for 7days | Drug | High loading and low maintenance |
| ClopidogrelClopidogrel loading 300mg and maintenance 150mg for 7days | Drug | Low loading and high maintenance |
| ClopidogrelClopidogrel loading 300mg and maintenance 75mg for 7days | Drug | Low loading and low maintenance |
Primary outcome
Inhibition of platelet aggregation 24 hours after loading
Time frame: 24 hours
9 secondary outcomes
Inhibition of platelet aggregation 7 days after loading
Time frame: 7 days
Inhibition of platelet aggregation 28 days after loading
Time frame: 28 days
all cause death
Time frame: 1 year
cardiac death
Time frame: 1 year
myocardial infarction
Time frame: 1 year
stent thrombosis (Academic Research Consortium definition)
Time frame: 1 year
acute hemorrhagic or ischemic stroke excluding transient ischemic attack
Time frame: 1 year
bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition)
Time frame: 1 year
composite of cardiac death, myocardial infarction and stroke
Time frame: 1 year
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 11 Jan 2016.
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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.
Takeshi Kimura, MD principal investigator
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
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 in people with Coronary Artery Disease, run by Takeshi Morimoto at 1 site in Japan.
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 2 inclusion and 7 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 11 Jan 2016. 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 Japan. 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?
Inhibition of platelet aggregation 24 hours after loading (time frame: 24 hours). 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 11 Jan 2016.