Cerebral InfarctionPhase 4MAESTRONCT01174693
Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping
A Phase 4 study testing Triflusal and Clopidogrel in people with Cerebral Infarction, run by Gangnam Severance Hospital at 18 sites in South Korea.
Trial summary
The purpose of this study is to compare the preventive effect of stroke between triflusal and clopidogrel in ischemic stroke patient based on the cytochrome P450 2C19 (CYP2C19) polymorphism. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Triflusal and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 795 participants
- Where
- 18 sitesSouth Korea
- Study dates
- Mar 2010to Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have non-cardiogenic ischemic stroke of TOAST classification within 30 days prior to screening
- ≥ 20 years of age; adult, at the date of signing the informed consent
- Written informed consent
Who cannot join
- History for bleeding tendency or recent major bleeding within 2 weeks
- Chronic liver disease (ALT > 100 IU/L or AST > 100 IU/L) or renal dysfunction (creatinine > 4.0 mg/dl)
- Thrombocytopenia (platelet < 100,000mm3)
- Any contraindication of antiplatelet agent
- Severe congestive heart failure
- Patients who need to take anticoagulants or two or more antiplatelet agents
Show all 9Show fewer
- Severe concomitant disease with the expected survival less than 2 years
- Pregnant or nursing
- Any drug clinical trials within 30 days of signing the informed consent
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Changwon Fatima Hospital
Changwon, Gyeongsangnam-do, 641-560
Keimyung University Dongsan Medical Center
Daegu, 700-712
Kyungpook National University Hospital
Daegu, 700-721
Yeungnam University Hospital
Daegu, 705-717
Department of Neurology, Konyang University Hospital
Daejeon, 302-718
Department of Neurology, National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-719
Department of Neurology, Chosun University Hospital
Gwangju, 501-717
Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine
Seongnam-si, Gyeonggi-do, 463-712
Department of Neurology, National Medical Center
Seoul, 100-799
Department of Neurology, Severance Hospital, Yonsei University College of Medicine
Seoul, 120-752
KyungHee University Medical Center
Seoul, 130-702
Department of Neurology, Kyung Hee University Hospital at Gangdong
Seoul, 134-727
Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine
Seoul, 135-720
Korea University Anam Hospital
Seoul, 136-705
Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine
Seoul, 139-707
Department of Neurology, Korea University Guro Hospital
Seoul, 152-703
Department of Neurology, Ewha Womans University Mokdong Hospital
Seoul, 158-710
Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine
Wŏnju, Gangwon-do, 220-701
About this study
Official title: Comparison of Triflusal and Clopidogrel Effect in Secondary Prevention of Stroke Based on the Cytochrome P450 2C19 Genotyping
The purpose of this study is to compare the preventive effect of stroke between triflusal and clopidogrel in ischemic stroke patient based on the cytochrome P450 2C19 (CYP2C19) polymorphism.
Read the detailed description
Clopidogrel has anti-platelet activity by irreversible inhibition of the P2Y12 platelet receptor. Clopidogrel must be converted into an active metabolite in order to show anti-platelet activity. Hepatic CYP2C19 enzyme is one of the key hepatic enzymes which convert clopidogrel into active metabolite and its genetic polymorphism is related to clopidogrel resistance. CYP2C19 poor or intermediate metabolizer groups show reduced anti-platelet activity of clopidogrel compared to extensive metabolizer group.
This study is designed to prove the superiority of the triflusal in preventing recurrent stroke over the clopidogrel in ischemic stroke patient with poor or intermediate metabolizer of CYP2C19 polymorphism. Also we plan to prove that clopidogrel resistance is related to CYP2C19 polymorphism by comparing the ischemic preventive effect of clopidogrel between groups of different CYP2C19 polymorphism.
- Conditions
- Cerebral Infarction
- Being tested
- Triflusal, Clopidogrel
- Keywords
- prospective, randomized, open label, multi-center, double-blind for CYP2C19 genotypes
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriflusalDrug
Also called Disgren®
Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
ClopidogrelDrug
Also called Plavix®
Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Active comparator | Plavix® 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014 Receives: Drug: Clopidogrel |
| Triflusal | Experimental | Disgre® 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014 Receives: Drug: Triflusal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first recurrent stroke
The study will finish at least 2 years after the recruit of 1080th patients. Until the finish, patients will continuously take study medications and visit every 3months at the study site.
We will measure primary outcome during the follow-up period (minimum 2.8 years to maximum 4 years - maximum time is determined by estimated enrollment time period of 2.8 years).
Measured: 2.8 to 4 years
Secondary outcomes (1)
Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke
The study will finish at least 2 years after the recruit of 1080th patients. Until the finish, patients will continuously take study medications and visit every 3months at the study site.
We will measure secondary outcomes during the follow-up period (minimum 2.8 years to maximum 4 years - maximum time is determined by estimated enrollment time period of 2.8 years).
Measured: 2.8 to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2014
- Study completionMar 2015
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 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
- 795 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Myung In Pharmaceutical Company, Yonsei University
- Responsible party
- Principal investigator, KyungYul Lee, Gangnam Severance Hospital
- Investigators
- KyungYul Lee, MD, PhD, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174693
- Sponsor's protocol ID
- MAESTRO-001
- Acronym
- MAESTRO
- Status last verified
- Mar 2015
- First submitted
- 3 Aug 2010
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Han SW, Kim YJ, Ahn SH, Seo WK, Yu S, Oh SH, Kim YN, Lee KY; MAESTRO Study Investigators. Protocol for the comparison of triflusal and clopidogrel in secondary prevention of stroke based on cytochrome P450 2C19 genotyping (MASETRO study): A multicenter, randomized, open-label, parallel-group trial. Int J Stroke. 2016 Jun;11(4):485-91. doi: 10.1177/1747493015620804. Epub 2016 Jan 5.
PubMed 26763917
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Triflusal and Clopidogrel Effect in Secondary Prevention of Stroke Based on the Cytochrome P450 2C19 Genotyping
- ClinicalTrials.gov ID
- NCT01174693
- Acronym / sponsor ID
- MAESTRO / MAESTRO-001
- Conditions
- Cerebral Infarction
- Keywords
- prospective, randomized, open label, multi-center, double-blind for CYP2C19 genotypes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 795 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Collaborators
- Myung In Pharmaceutical Company, Yonsei University
- Study start
- Mar 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Aug 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 compare the preventive effect of stroke between triflusal and clopidogrel in ischemic stroke patient based on the cytochrome P450 2C19 (CYP2C19) polymorphism.
Detailed description
Clopidogrel has anti-platelet activity by irreversible inhibition of the P2Y12 platelet receptor. Clopidogrel must be converted into an active metabolite in order to show anti-platelet activity. Hepatic CYP2C19 enzyme is one of the key hepatic enzymes which convert clopidogrel into active metabolite and its genetic polymorphism is related to clopidogrel resistance. CYP2C19 poor or intermediate metabolizer groups show reduced anti-platelet activity of clopidogrel compared to extensive metabolizer group.
This study is designed to prove the superiority of the triflusal in preventing recurrent stroke over the clopidogrel in ischemic stroke patient with poor or intermediate metabolizer of CYP2C19 polymorphism. Also we plan to prove that clopidogrel resistance is related to CYP2C19 polymorphism by comparing the ischemic preventive effect of clopidogrel between groups of different CYP2C19 polymorphism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Active comparator | Drug: ClopidogrelPlavix® 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014 |
| Triflusal | Experimental | Drug: TriflusalDisgre® 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have non-cardiogenic ischemic stroke of TOAST classification within 30 days prior to screening
- ≥ 20 years of age; adult, at the date of signing the informed consent
- Written informed consent
Key exclusion criteria (9 listed)
- History for bleeding tendency or recent major bleeding within 2 weeks
- Chronic liver disease (ALT > 100 IU/L or AST > 100 IU/L) or renal dysfunction (creatinine > 4.0 mg/dl)
- Thrombocytopenia (platelet < 100,000mm3)
- Any contraindication of antiplatelet agent
- Severe congestive heart failure
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 |
|---|---|---|
| TriflusalAlso: Disgren®Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014 | Drug | Triflusal |
| ClopidogrelAlso: Plavix®Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014 | Drug | Clopidogrel |
Primary outcome
Time to first recurrent stroke
Time frame: 2.8 to 4 years
The study will finish at least 2 years after the recruit of 1080th patients. Until the finish, patients will continuously take study medications and visit every 3months at the study site. We will measure primary outcome during the follow-up period (minimum 2.8 years to maximum 4 years - maximum time is determined by estimated enrollment time period of 2.8 years).
1 secondary outcome
Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke
Time frame: 2.8 to 4 years
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 17 Mar 2015.
- Derived from this study: PubMed 26763917Han SW, Kim YJ, Ahn SH, Seo WK, Yu S, Oh SH, Kim YN, Lee KY; MAESTRO Study Investigators. Protocol for the comparison of triflusal and clopidogrel in secondary prevention of stroke based on cytochrome P450 2C19 genotyping (MASETRO study): A multicenter, randomized, open-label, parallel-group trial. Int J Stroke. 2016 Jun;11(4):485-91. doi: 10.1177/1747493015620804. Epub 2016 Jan 5.
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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.
KyungYul Lee, MD, PhD principal investigator
Gangnam Severance Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triflusal and Clopidogrel in people with Cerebral Infarction, run by Gangnam Severance Hospital at 18 sites 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
Time to first recurrent stroke (time frame: 2.8 to 4 years). 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 NCT01174693, 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 17 Mar 2015.