Cerebral InfarctionPhase 4NCT00386191
Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment
A Phase 4 study testing clopidogrel (SR25990C) in people with Cerebral Infarction, run by Sanofi at 1 site in Japan.
Trial summary
The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- clopidogrel (SR25990C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,110 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2006to Dec 2008
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an episode of cerebral infarction (excluding cardiogenic cerebral thromboembolism) occurring at least 8 days prior to randomization and for whom the clinical course up to randomization is well-documented
- Patients with a cerebral infarct confirmed by Computed Tomography or Magnetic Resonance Image
- Body weight : > 50 kg
Who cannot join
- Patients with cardiogenic cerebral thromboembolism or disease that could precipitate cardiogenic cerebral thromboembolism, such as atrial fibrillation or valvular hear disease (including valve replacement)
- Patients with Transient Ischemic Attack occuring after the last episode of cerebral infarction
- Patients with serious impairment that would hinder detection of new ischemic event
- Patients with bleeding diathesis, coagulopathy, or hemorrhagic disease
- Patients with history of intracranial hemorrhage
- Patients with diabetic retinopathy
- Hypertensive patients with a persistent increase of blood pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction
The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.
- Conditions
- Cerebral Infarction
- Being tested
- clopidogrel (SR25990C)
- Keywords
- Platelet Aggregation Inhibitors, Ischemic cerebrovascular disease
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrel (SR25990C)Drug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 50 mg Receives: Drug: clopidogrel (SR25990C) |
| 2 | Experimental | 75 mg Receives: Drug: clopidogrel (SR25990C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding adverse events
Measured: study period
Secondary outcomes (1)
Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events.
Measured: study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386191
- Sponsor's protocol ID
- SFY6913
- Other IDs
- SR25990
- Status last verified
- Feb 2010
- First submitted
- 10 Oct 2006
- Last updated
- 24 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction
- ClinicalTrials.gov ID
- NCT00386191
- Acronym / sponsor ID
- SFY6913
- Conditions
- Cerebral Infarction
- Keywords
- Platelet Aggregation Inhibitors, Ischemic cerebrovascular disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Oct 2006 (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 primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: clopidogrel (SR25990C)50 mg |
| 2 | Experimental | Drug: clopidogrel (SR25990C)75 mg |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an episode of cerebral infarction (excluding cardiogenic cerebral thromboembolism) occurring at least 8 days prior to randomization and for whom the clinical course up to randomization is well-documented
- Patients with a cerebral infarct confirmed by Computed Tomography or Magnetic Resonance Image
- Body weight : > 50 kg
Key exclusion criteria (7 listed)
- Patients with cardiogenic cerebral thromboembolism or disease that could precipitate cardiogenic cerebral thromboembolism, such as atrial fibrillation or valvular hear disease (including valve replacement)
- Patients with Transient Ischemic Attack occuring after the last episode of cerebral infarction
- Patients with serious impairment that would hinder detection of new ischemic event
- Patients with bleeding diathesis, coagulopathy, or hemorrhagic disease
- Patients with history of intracranial hemorrhage
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 |
|---|---|---|
| clopidogrel (SR25990C)oral administration | Drug | 1, 2 |
Primary outcome
Incidence of bleeding adverse events
Time frame: study period
1 secondary outcome
Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events.
Time frame: study period
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 24 Feb 2010.
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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.
ICD CSD study director
Sanofi
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 (SR25990C) in people with Cerebral Infarction, run by Sanofi 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 3 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 24 Feb 2010. 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?
Incidence of bleeding adverse events (time frame: study period). 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 24 Feb 2010.