Cerebral InfarctionPhase 4NCT02411903
The Dynamic Effect of Non-cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized and Cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized Statins on Clopidogrel Resistance in Patients With Cerebral Infarction
A Phase 4 study testing atorvastatin and clopidogrel and rosuvastatin and clopidogrel in people with Cerebral Infarction and Clopidogrel,Poor Metabolism of (Disorder), run by The Third Affiliated Hospital of Guangzhou Medical University.
Trial summary
The investigators team had found that the presence of dynamic changes of Clopidogrel resistance are not associated with genetic factors. Currently, study on moderate doses of statins and dynamic Clopidogrel resistance has not been reported, therefore this study will observe 160 cases of open prospective secondary… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Cerebral Infarction, Clopidogrel,Poor Metabolism of (Disorder)
- What is being tested?
- atorvastatin and clopidogrel and rosuvastatin and clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Aug 2016
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Age <85 years and >45 years ,Male or female.
- The patient have been Cerebral infarction for one month.
- national institutes of health stroke scale（NIHSS）score ≤23 points.
- Blood Platelet count greater than 150×10^9／L,and Less than 500×10^9／L.
- The patient never do not taking aspirin 、dipyridamole、clopidogrel,or the patient had been taken these anti-platelet drugs but has been discontinued for two weeks at least.
- The patient never do not taking Statins or the patient have been stop taking statins 2 weeks for two weeks.
Who cannot join
- Allergic constitution , or allergic to the composition of the drugs in this study.
- national institutes of health stroke scale（NIHSS） score >23 points.
- Atrial fibrillation and other cardiogenic cerebral embolism.
- Patients who were undergone surgery and trauma (including fractures) within the past three month.
- Patients with known dysfunction of vital organs or suffered from Serious cardiovascular disease ，or coagulation disorders.
- The patient took Proton pump inhibitors recently.
- The history of data collection and the follow-up process can not be saved.
About this study
The investigators team had found that the presence of dynamic changes of Clopidogrel resistance are not associated with genetic factors. Currently, study on moderate doses of statins and dynamic Clopidogrel resistance has not been reported, therefore this study will observe 160 cases of open prospective secondary prevention in patients with cerebral infarction. Excluded: those patients occurs Clopidogrel resistance because of slow metabolism caused by cytochrome P450 isoenzyme 2C19（CYP2C19, and then observed the impact of the cytochrome P450 isoenzyme 3A4 （CYP3A4）-metabolized and non-cytochrome P450 isoenzyme 3A4 （CYP3A4）-metabolized statins dynamically on Clopidogrel resistance in the next 9 months, adverse events will be recorded, the metabolite of clopidogrel（H4 ）and the polymorphism of cytochrome P450 isoenzyme 2C19 （CYP2C19）/cytochrome P450 isoenzyme 3A4 （CYP3A4）/ cytochrome P450 isoenzyme 2C9（CYP2C9）will be detected. Expected Result: the patients use the cytochrome P450 isoenzyme 3A4（CYP3A4）-metabolized statins will result in dynamic Clopidogrel resistance easily ,H4 levels will decline, and Clopidogrel resistance is not related to the polymorphism of cytochrome P450 isoenzyme 3A4 （CYP3A4）.
- Being tested
- atorvastatin and clopidogrel, rosuvastatin and clopidogrel
- Keywords
- Clopidogrel-drug interactions
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatin and clopidogrelDrug
Dose: atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months.
rosuvastatin and clopidogrelDrug
Dose: rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin and Clopidogrel | Active comparator | 80 patients will be taking atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months。 Receives: Drug: atorvastatin and clopidogrel |
| rosuvastatin and Clopidogrel | Experimental | 80 patients will be taking rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months。 Receives: Drug: rosuvastatin and clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of clopidogrel resistance
Definition of clopidogrel resistance is the absolute change of 5 microliter adenosine diphosphate(ADP) induced PAR≤10% as compared to baseline. So, incidence of clopidogrel resistance= (PAR at monitor point - PAR at baseline) / PAR at baseline×100 %≤10 %。 Measures of PAR: PAR is measured by Light transmittance aggregometry (LTA) and according to the standard of Rev。
Measured: For nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctionStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Rong Zhou, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411903
- Sponsor's protocol ID
- H0906
- Status last verified
- Apr 2015
- First submitted
- 17 Mar 2015
- Last updated
- 16 Jun 2015
- Results posted
- No
Publications
Sugunaraj JP, Palaniswamy C, Selvaraj DR, Chaitanya Arudra SK, Sukhija R. Clopidogrel resistance. Am J Ther. 2010 Mar-Apr;17(2):210-5. doi: 10.1097/MJT.0b013e3181bdc3e4.
PubMed 19829090Nguyen TA, Diodati JG, Pharand C. Resistance to clopidogrel: a review of the evidence. J Am Coll Cardiol. 2005 Apr 19;45(8):1157-64. doi: 10.1016/j.jacc.2005.01.034.
PubMed 15837243Lev EI, Patel RT, Maresh KJ, Guthikonda S, Granada J, DeLao T, Bray PF, Kleiman NS. Aspirin and clopidogrel drug response in patients undergoing percutaneous coronary intervention: the role of dual drug resistance. J Am Coll Cardiol. 2006 Jan 3;47(1):27-33. doi: 10.1016/j.jacc.2005.08.058. Epub 2005 Dec 9.
PubMed 16386660
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dynamic Effect of Non-cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized and Cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized Statins on Clopidogrel Resistance in Patients With Cerebral Infarction
- ClinicalTrials.gov ID
- NCT02411903
- Acronym / sponsor ID
- H0906
- Keywords
- Clopidogrel-drug interactions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 8 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 investigators team had found that the presence of dynamic changes of Clopidogrel resistance are not associated with genetic factors. Currently, study on moderate doses of statins and dynamic Clopidogrel resistance has not been reported, therefore this study will observe 160 cases of open prospective secondary prevention in patients with cerebral infarction. Excluded: those patients occurs Clopidogrel resistance because of slow metabolism caused by cytochrome P450 isoenzyme 2C19（CYP2C19, and then observed the impact of the cytochrome P450 isoenzyme 3A4 （CYP3A4）-metabolized and non-cytochrome P450 isoenzyme 3A4 （CYP3A4）-metabolized statins dynamically on Clopidogrel resistance in the next 9 months, adverse events will be recorded, the metabolite of clopidogrel（H4 ）and the polymorphism of cytochrome P450 isoenzyme 2C19 （CYP2C19）/cytochrome P450 isoenzyme 3A4 （CYP3A4）/ cytochrome P450 isoenzyme 2C9（CYP2C9）will be detected. Expected Result: the patients use the cytochrome P450 isoenzyme 3A4（CYP3A4）-metabolized statins will result in dynamic Clopidogrel resistance easily ,H4 levels will decline, and Clopidogrel resistance is not related to the polymorphism of cytochrome P450 isoenzyme 3A4 （CYP3A4）.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atorvastatin and Clopidogrel | Active comparator | Drug: atorvastatin and clopidogrel80 patients will be taking atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months。 |
| rosuvastatin and Clopidogrel | Experimental | Drug: rosuvastatin and clopidogrel80 patients will be taking rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months。 |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Age <85 years and >45 years ,Male or female.
- The patient have been Cerebral infarction for one month.
- national institutes of health stroke scale（NIHSS）score ≤23 points.
- Blood Platelet count greater than 150×10^9／L,and Less than 500×10^9／L.
Key exclusion criteria (7 listed)
- Allergic constitution , or allergic to the composition of the drugs in this study.
- national institutes of health stroke scale（NIHSS） score >23 points.
- Atrial fibrillation and other cardiogenic cerebral embolism.
- Patients who were undergone surgery and trauma (including fractures) within the past three month.
- Patients with known dysfunction of vital organs or suffered from Serious cardiovascular disease ，or coagulation disorders.
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 |
|---|---|---|
| atorvastatin and clopidogrelDose: atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months. | Drug | atorvastatin and Clopidogrel |
| rosuvastatin and clopidogrelDose: rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months. | Drug | rosuvastatin and Clopidogrel |
Primary outcome
incidence of clopidogrel resistance
Time frame: For nine months
Definition of clopidogrel resistance is the absolute change of 5 microliter adenosine diphosphate(ADP) induced PAR≤10% as compared to baseline. So, incidence of clopidogrel resistance= (PAR at monitor point - PAR at baseline) / PAR at baseline×100 %≤10 %。 Measures of PAR: PAR is measured by Light transmittance aggregometry (LTA) and according to the standard of Rev。
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- Results publication: PubMed 19829090Sugunaraj JP, Palaniswamy C, Selvaraj DR, Chaitanya Arudra SK, Sukhija R. Clopidogrel resistance. Am J Ther. 2010 Mar-Apr;17(2):210-5. doi: 10.1097/MJT.0b013e3181bdc3e4.
- Results publication: PubMed 15837243Nguyen TA, Diodati JG, Pharand C. Resistance to clopidogrel: a review of the evidence. J Am Coll Cardiol. 2005 Apr 19;45(8):1157-64. doi: 10.1016/j.jacc.2005.01.034.
- Results publication: PubMed 16386660Lev EI, Patel RT, Maresh KJ, Guthikonda S, Granada J, DeLao T, Bray PF, Kleiman NS. Aspirin and clopidogrel drug response in patients undergoing percutaneous coronary intervention: the role of dual drug resistance. J Am Coll Cardiol. 2006 Jan 3;47(1):27-33. doi: 10.1016/j.jacc.2005.08.058. Epub 2005 Dec 9.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atorvastatin and clopidogrel and rosuvastatin and clopidogrel in people with Cerebral Infarction and Clopidogrel,Poor Metabolism of (Disorder), run by The Third Affiliated Hospital of Guangzhou Medical University.
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 7 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: status not confirmed, as of the sponsor's last update on 16 Jun 2015. 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?
Results are not available in the source record.
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?
incidence of clopidogrel resistance (time frame: For nine months). 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 NCT02411903, which also lists 3 linked publications.
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 16 Jun 2015.