Clopidogrel Non-Responsiveness4C-DESNCT00620646
The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol
A study testing aspirin, clopidogrel and aspirin, clopidogrel, cilostazol in people with Clopidogrel Non-Responsiveness, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clopidogrel Non-Responsiveness
- What is being tested?
- aspirin, clopidogrel and aspirin, clopidogrel, cilostazol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2008to Feb 2009
- Phase
- Interventional
- 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
- Patient with clopidogrel resistance with treatment of dual antiplatelet agent, aspirin and clopidogrel, for more than 4 weeks after drug-eluting stent
- Clopidogrel resistance is defined as a patients with platelet inhibition less than 30% in platelet function test(VerifyNow-P2Y12 assayTM, Accumetrics, San Diego, CA, USA)
Who cannot join
- Acute myocardial infarction within 2 weeks
- Unstable angina within 2 weeks
- History of using glycoprotein IIb/IIIa inhibitor within 1 month
- Cerebral infarction within 3 months
- Bleeding diathesis like coagulation disorder, thrombocytopenia (platelet count < 100,000/uL)
- history of gastrointestinal bleeding or genitourinary bleeding within 3 months
Show all 12Show fewer
- needed oral anticoagulation
- aspirin, clopidogrel or cilostazol hypersensitivity
- congestive heart failure
- serum creatinine level >2mg/dl
- malignancy
- using cytochrome P450 inhibitor (eg, itraconazole)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation
To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance
Read the detailed description
Using dual antiplatelet agents with aspirin and clopidogrel is essential after drug-eluting stent implantation to prevent restenosis and stent thrombosis. However, variable platelet response and potential resistance to therapy have emerged with clopidogrel. Several studies showed that clopidogrel resistance is associated with increased cardiovascular events after coronary interventions. New antiplatelet therapeutic strategy of is needed in case of clopidogrel resistance. We started this study to compare the effect of double dosing of clopidogrel to 150mg per day and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance.
- Conditions
- Clopidogrel Non-Responsiveness
- Being tested
- aspirin, clopidogrel, aspirin, clopidogrel, cilostazol
- Keywords
- clopidogrel, platelets, percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin, clopidogrelDrug
aspirin 100 mg plus clopidogrel 150mg qd
aspirin, clopidogrel, cilostazolDrug
aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Aspirin plus increasing clopidogrel group Receives: Drug: aspirin, clopidogrel |
| B | Experimental | Aspirin, clopidogrel plus cilostazol group Receives: Drug: aspirin, clopidogrel, cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
% platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test
Measured: 4 weeks
Secondary outcomes (1)
P2Y12 reaction unit (PRU)
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 posted21 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clopidogrel Non-ResponsivenessStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hyeon-Cheol Gwon, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620646
- Sponsor's protocol ID
- 2006-12-026
- Acronym
- 4C-DES
- Status last verified
- Feb 2009
- First submitted
- 27 Jan 2008
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT00620646
- Acronym / sponsor ID
- 4C-DES / 2006-12-026
- Conditions
- Clopidogrel Non-Responsiveness
- Keywords
- clopidogrel, platelets, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 21 Feb 2008 (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.
To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance
Detailed description
Using dual antiplatelet agents with aspirin and clopidogrel is essential after drug-eluting stent implantation to prevent restenosis and stent thrombosis. However, variable platelet response and potential resistance to therapy have emerged with clopidogrel. Several studies showed that clopidogrel resistance is associated with increased cardiovascular events after coronary interventions. New antiplatelet therapeutic strategy of is needed in case of clopidogrel resistance. We started this study to compare the effect of double dosing of clopidogrel to 150mg per day and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: aspirin, clopidogrelAspirin plus increasing clopidogrel group |
| B | Experimental | Drug: aspirin, clopidogrel, cilostazolAspirin, clopidogrel plus cilostazol group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with clopidogrel resistance with treatment of dual antiplatelet agent, aspirin and clopidogrel, for more than 4 weeks after drug-eluting stent
- Clopidogrel resistance is defined as a patients with platelet inhibition less than 30% in platelet function test(VerifyNow-P2Y12 assayTM, Accumetrics, San Diego, CA, USA)
Key exclusion criteria (12 listed)
- Acute myocardial infarction within 2 weeks
- Unstable angina within 2 weeks
- History of using glycoprotein IIb/IIIa inhibitor within 1 month
- Cerebral infarction within 3 months
- Bleeding diathesis like coagulation disorder, thrombocytopenia (platelet count < 100,000/uL)
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 |
|---|---|---|
| aspirin, clopidogrelaspirin 100 mg plus clopidogrel 150mg qd | Drug | A |
| aspirin, clopidogrel, cilostazolaspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid | Drug | B |
Primary outcome
% platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test
Time frame: 4 weeks
1 secondary outcome
P2Y12 reaction unit (PRU)
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 12 Feb 2009.
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.
Hyeon-Cheol Gwon, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aspirin, clopidogrel and aspirin, clopidogrel, cilostazol in people with Clopidogrel Non-Responsiveness, run by Samsung Medical Center 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 2 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 2009. 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.
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?
% platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test (time frame: 4 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 12 Feb 2009.