Cerebral InfarctionPhase 3NCT00129805
Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)
A Phase 3 study testing MCI-9042 and Aspirin in people with Cerebral Infarction, run by Tanabe Pharma Corporation.
Trial summary
Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease. 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?
- MCI-9042 and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,510 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Sep 2004
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cerebral infarction except cardiac source of embolism
- Onset ≧ 1 week to ≦ 6 months before randomization
- Neurological signs persisting ≧ 1 day from onset
- Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site
- Age ≧ 20 years
- Systolic pressure ≦ 180 mmHg; diastolic pressure ≦ 110 mmHg
Who cannot join
- Functional outcome at randomization: Modified Rankin Scale = 4, 5
- Previous or planned vascular surgery for cerebral infarction
- History of intracranial hemorrhage
- History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
- Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.)
- Pregnant or possibly pregnant women, or nursing mothers
Show all 9Show fewer
- History of sarpogrelate and aspirin sensitivity
- Treating malignant tumor or treated within 5 years
- Current peptic ulceration
About this study
Official title: Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial
Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease.
S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.
- Conditions
- Cerebral Infarction
- Being tested
- MCI-9042, Aspirin
- 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
Also called Sarpogrelate(INN), ANPLAG(R)
AspirinDrug
| Study group | Role | What they receive |
|---|---|---|
| MCI-9042 | Experimental | Not described Receives: Drug: MCI-9042 |
| Aspirin | Active comparator | Not described Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of cerebral infarction
Secondary outcomes (1)
intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startJan 2001
- Primary completionSep 2004
- Study completionSep 2004
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yukito Shinohara, MD, Study chair, Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129805
- Sponsor's protocol ID
- MCI9042-15
- Status last verified
- Aug 2008
- First submitted
- 11 Aug 2005
- Last updated
- 19 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Shinohara Y, Nishimaru K, Sawada T, Terashi A, Handa S, Hirai S, Hayashi K, Tohgi H, Fukuuchi Y, Uchiyama S, Yamaguchi T, Kobayashi S, Kondo K, Otomo E, Gotoh F; S-ACCESS Study Group. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A randomized, double-blind, aspirin-controlled trial. Stroke. 2008 Jun;39(6):1827-33. doi: 10.1161/STROKEAHA.107.505131. Epub 2008 Apr 3.
PubMed 18388340
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial
- ClinicalTrials.gov ID
- NCT00129805
- Acronym / sponsor ID
- MCI9042-15
- Conditions
- Cerebral Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,510 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 12 Aug 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 (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease.
S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI-9042 | Experimental | Drug: MCI-9042 |
| Aspirin | Active comparator | Drug: Aspirin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cerebral infarction except cardiac source of embolism
- Onset ≧ 1 week to ≦ 6 months before randomization
- Neurological signs persisting ≧ 1 day from onset
- Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site
- Age ≧ 20 years
Key exclusion criteria (9 listed)
- Functional outcome at randomization: Modified Rankin Scale = 4, 5
- Previous or planned vascular surgery for cerebral infarction
- History of intracranial hemorrhage
- History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
- Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.)
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-9042Also: Sarpogrelate(INN), ANPLAG(R) | Drug | MCI-9042 |
| Aspirin | Drug | Aspirin |
Primary outcome
recurrence of cerebral infarction
1 secondary outcome
intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death
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 19 Aug 2008.
- Results publication: PubMed 18388340Shinohara Y, Nishimaru K, Sawada T, Terashi A, Handa S, Hirai S, Hayashi K, Tohgi H, Fukuuchi Y, Uchiyama S, Yamaguchi T, Kobayashi S, Kondo K, Otomo E, Gotoh F; S-ACCESS Study Group. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A randomized, double-blind, aspirin-controlled trial. Stroke. 2008 Jun;39(6):1827-33. doi: 10.1161/STROKEAHA.107.505131. Epub 2008 Apr 3.
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.
Yukito Shinohara, MD study chair
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MCI-9042 and Aspirin 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 6 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 19 Aug 2008. 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?
recurrence of cerebral infarction. 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 NCT00129805, 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 19 Aug 2008.