Cerebral InfarctionPhase 3NCT00147303
Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Dose-responsive Clinical Pharmacology Study
A Phase 3 study testing MCI-9042 in people with Cerebral Infarction, run by Tanabe Pharma Corporation.
Trial summary
Sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-HT )levels in platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral arterial disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- MCI-9042
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Jan 2005
- Phase
- Phase 3
- 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
- Cerebral infarction except cardiac source of embolism based on the NINDSⅢclassification
- Neurological signs persisting≧ 1 day from onset
- Defined onset of symptoms, and stable condition at the period of enrollment
- CT or MRI detection of responsible site
- age≧20
- Systolic pressure≦180 mmHg, Diastolic pressure≦110 mmHg
- The maximum intensity of platelet aggregation is above 15 % induced by serotonin (1µM) and epinephrine (3µM) on the day of prior to the first medication
- Written informed consent must be obtained from the patients before enrollment into the study
Who cannot join
- Functional outcome at randomization: Modified Rankin Scale=4, 5
- Previous or planned for vascular surgery to cerebral infarction
- History of intracranial hemorrhage
- History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
- With severe complications ( renal or hepatic insufficiency, heart failure, hemopathy, and so on )
- Treating malignant tumor
Show all 11Show fewer
- Pregnant or possibly pregnant women, or nursing mothers
- History of sarpogrelate sensitivity
- Previously entered in other clinical trials within 3 months
- Less than 3 months since any other clinical trial
- Judged by investigator to be unsuitable for the study
About this study
Official title: Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Clinical-pharmacological Dose-response Study.
Sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-HT )levels in platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral arterial disease.
The present double-blind controlled clinical pharmacology study was performed on 45 patients with cerebral infarction, who were given 75, 150, or 300 mg three times daily of sarpogrelate for 7 days in order to evaluate the dose-response relationship in terms of the precisely measured inhibition of platelet aggregation.
- Conditions
- Cerebral Infarction
- Being tested
- MCI-9042
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCI-9042Drug
| Study group | Role | What they receive |
|---|---|---|
| group L | Experimental | 25mg sarpogrelate Receives: Drug: MCI-9042 |
| group M | Experimental | 50mg sarpogrelate Receives: Drug: MCI-9042 |
| group H | Experimental | 100mg sarpogrelate Receives: Drug: MCI-9042 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum intensity of platelet aggregation on the last day of medication and as post-treatment percentage inhibition of the maximum intensity of platelet aggregation at baseline [(baseline - post-treatment )/baseline × 100 in each subject].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionJan 2005
- Study completionJan 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shinichiro Uchiyama, MD, Study chair, Tokyo Women's Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147303
- Sponsor's protocol ID
- MCI9042-17
- Status last verified
- Apr 2015
- First submitted
- 4 Sep 2005
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Uchiyama S, Ozaki Y, Satoh K, Kondo K, Nishimaru K. Effect of sarpogrelate, a 5-HT(2A) antagonist, on platelet aggregation in patients with ischemic stroke: clinical-pharmacological dose-response study. Cerebrovasc Dis. 2007;24(2-3):264-70. doi: 10.1159/000105135. Epub 2007 Jul 4.
PubMed 17622759
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Clinical-pharmacological Dose-response Study.
- ClinicalTrials.gov ID
- NCT00147303
- Acronym / sponsor ID
- MCI9042-17
- Conditions
- Cerebral Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 7 Sep 2005 (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.
Sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-HT )levels in platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral arterial disease.
The present double-blind controlled clinical pharmacology study was performed on 45 patients with cerebral infarction, who were given 75, 150, or 300 mg three times daily of sarpogrelate for 7 days in order to evaluate the dose-response relationship in terms of the precisely measured inhibition of platelet aggregation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group L | Experimental | Drug: MCI-904225mg sarpogrelate |
| group M | Experimental | Drug: MCI-904250mg sarpogrelate |
| group H | Experimental | Drug: MCI-9042100mg sarpogrelate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Cerebral infarction except cardiac source of embolism based on the NINDSⅢclassification
- Neurological signs persisting≧ 1 day from onset
- Defined onset of symptoms, and stable condition at the period of enrollment
- CT or MRI detection of responsible site
- age≧20
Key exclusion criteria (11 listed)
- Functional outcome at randomization: Modified Rankin Scale=4, 5
- Previous or planned for vascular surgery to cerebral infarction
- History of intracranial hemorrhage
- History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
- With severe complications ( renal or hepatic insufficiency, heart failure, hemopathy, and so on )
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 |
|---|---|---|
| MCI-9042 | Drug | group H, group L, group M |
Primary outcome
The maximum intensity of platelet aggregation on the last day of medication and as post-treatment percentage inhibition of the maximum intensity of platelet aggregation at baseline [(baseline - post-treatment )/baseline × 100 in each subject].
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 10 Apr 2015.
- Results publication: PubMed 17622759Uchiyama S, Ozaki Y, Satoh K, Kondo K, Nishimaru K. Effect of sarpogrelate, a 5-HT(2A) antagonist, on platelet aggregation in patients with ischemic stroke: clinical-pharmacological dose-response study. Cerebrovasc Dis. 2007;24(2-3):264-70. doi: 10.1159/000105135. Epub 2007 Jul 4.
Related trials for Cerebral Infarction
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
Shinichiro Uchiyama, MD study chair
Tokyo Women's Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MCI-9042 in people with Cerebral Infarction, run by Tanabe Pharma Corporation.
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 8 inclusion and 11 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 10 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The maximum intensity of platelet aggregation on the last day of medication and as post-treatment percentage inhibition of the maximum intensity of platelet aggregation at baseline [(baseline - post-treatment )/baseline × 100 in each subject].. 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 NCT00147303, 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 10 Apr 2015.