Cerebrovascular DiseasePhase 3NCT00333164
Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis
A Phase 3 study testing Asprin, Cilostazol in people with Cerebrovascular Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
Multi-center, open-labelled randomized controlled trial, to study the effect of aspirin plus cilostazol and aspirin alone on the progression of intracranial arterial stenosis, in 200 chronic stroke patients with 50-99% stenosis, to be followed up for 2 years Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- Asprin, Cilostazol
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- May 2006to Mar 2012
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Ischemic stroke after two weeks to six months from onset,
- (2) Responsible lesion identified on MRI,
- ( 3) Intracranial arterial stenosis >50% on MRA in the territory of responsible lesion,
- (4) Intracranial arterial stenosis in suproclinoid internal carotid arterry, M1 portion of midlle cerebral artery, or basilar artery,
- (5) Age of 45 to 85 years,
- (6) Able to visit out-patient clinic, and
- (7) Written informed consent obtained from patient or family.
Who cannot join
- (1) Patients with potential cardiac embolic sources,
- (2) Patients receiving cilostazol,
- (3) Patients on warfarin treatment,
- (4) Patients in whom MRI cannot be perfomed,
- (5) Patients in whom PTA or bypass surgery is planned,
- (6) Patients with history of symptomatic intracranial hemorrhage, other hemorrhagic diseases (active peptic ulcer etc.), hemophilia or coagulation abnormalities,
Show all 14Show fewer
- (7) Patients with hypersensitivity to cilostazol or aspirin,
- (8) Patients with congestive heart failure or uncontrollable angina pectoris,
- (9) Patients with thrombocytopenia (<100,000/mm3),
- (10) Patients with liver dysfunction (AST or ALT >100 IU/L),
- (11) Patients with renal dysfunction (Creatinin >2.0 mg/dl),
- (12) Patients who cannot to be followed up during the study period,
- (13) Patients who are enrolled in other clinical trials, and
- (14) Patients inadequate for this study by other reasons.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Tokyo Women's Medical University School of Medicine
Shinjuku-ku, Tokyo, 162-8666
About this study
Official title: Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis (CATHARSIS)
Multi-center, open-labelled randomized controlled trial, to study the effect of aspirin plus cilostazol and aspirin alone on the progression of intracranial arterial stenosis, in 200 chronic stroke patients with 50-99% stenosis, to be followed up for 2 years
Read the detailed description
Intracraial arterial stenosis (IAS) is more common in Asia, including Japanese, than in Cocasian. Also, stroke recurrence rate is high in patients with such lesions, despite medical treatment. Accoding to the result of WASID (N Engl J Med 2005;352:1305-16), warfarin is not recommended because of the concern of safety (higher risk of intracranial hemorrhage and death when compared with aspirin), wheras the efficacy of aspirin is not enough in symptomatic IAS patients. Under these conditions, we planned to conduct a nationwide multi-center, open labelled, randomized controlled trial to compare the effect of aspirin plus cilostazol (phosphodiestrase type 3 inhibitor) and aspirin alone on the progression of IAS in 200 IAS patients with ischemic stroke after 2 weeks to 6 months of onset. Patients are randomly allocated to either of two groups. Aspirin 100mg/day plus cilostazol 200 mg/day is given to the 100 patients in one group, and aspirin 100 mg/day alone is given to 100 patients in another group.
Follow-up period is at least two years. The primary endpoint is progression of IAS on MRA at two years after randomization. The secondary endpoints are cardiovascular events (ischemic stroke, myocardial infarct, and other vascular events), death, serious adverse events, new silent brain infarcts, and activity of daily life. The purpose of this study is to establish the best medical treatment in symptomatic IAS patients. This study will also provide important information for the future randomized controlled study to compare medical treatment alone and intravascular intervetnion (PTA and/or stenting) in these patients.
- Conditions
- Cerebrovascular Disease
- Being tested
- Asprin, Cilostazol
- Keywords
- intracranial arteriosclerosis, cilostazol, Platelete aggrigation inhibitors dual antiplatelet therapy, Drug therapy, combination, Clinical trials
- Medical subject headings
- Cerebrovascular Disorders, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asprin, CilostazolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of intracranial arterial stenosis after two years
Secondary outcomes (3)
Cardiovascular events (ischemic stroke, cardiac infarctin, and other vascular events ）,
death (stroke death, vascular death except for stroke ）,
serious adverse events, new silent brain infarcts, and degrees of activity of daily living.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Biomedical Research and Innovation, Neurology, Tokyo Women's Medical University, School of Medicine, Kobe City General Hospital, Tohoku University, Kyushu University, Department of Neurology, Saiseikai Central Hospital, China National Center for Cardiovascular Diseases
- Investigators
- Shinichiro Uchiyama, M.D. PhD, Principal investigator, Department of Neurology, Tokyo Women's Medical University School of MedicineNobuyuki Sakai, M.D. PhD, Principal investigator, Kobe City General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333164
- Sponsor's protocol ID
- UHA STROKE04-01
- Status last verified
- Aug 2012
- First submitted
- 1 Jun 2006
- Last updated
- 19 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis (CATHARSIS)
- ClinicalTrials.gov ID
- NCT00333164
- Acronym / sponsor ID
- UHA STROKE04-01
- Conditions
- Cerebrovascular Disease
- Keywords
- intracranial arteriosclerosis, cilostazol, Platelete aggrigation inhibitors dual antiplatelet therapy, Drug therapy, combination, Clinical trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Foundation for Biomedical Research and Innovation, Neurology, Tokyo Women's Medical University, School of Medicine, Kobe City General Hospital, Tohoku University, Kyushu University, Department of Neurology, Saiseikai Central Hospital, China National Center for Cardiovascular Diseases
- Study start
- May 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Jun 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.
Multi-center, open-labelled randomized controlled trial, to study the effect of aspirin plus cilostazol and aspirin alone on the progression of intracranial arterial stenosis, in 200 chronic stroke patients with 50-99% stenosis, to be followed up for 2 years
Detailed description
Intracraial arterial stenosis (IAS) is more common in Asia, including Japanese, than in Cocasian. Also, stroke recurrence rate is high in patients with such lesions, despite medical treatment. Accoding to the result of WASID (N Engl J Med 2005;352:1305-16), warfarin is not recommended because of the concern of safety (higher risk of intracranial hemorrhage and death when compared with aspirin), wheras the efficacy of aspirin is not enough in symptomatic IAS patients. Under these conditions, we planned to conduct a nationwide multi-center, open labelled, randomized controlled trial to compare the effect of aspirin plus cilostazol (phosphodiestrase type 3 inhibitor) and aspirin alone on the progression of IAS in 200 IAS patients with ischemic stroke after 2 weeks to 6 months of onset. Patients are randomly allocated to either of two groups. Aspirin 100mg/day plus cilostazol 200 mg/day is given to the 100 patients in one group, and aspirin 100 mg/day alone is given to 100 patients in another group.
Follow-up period is at least two years. The primary endpoint is progression of IAS on MRA at two years after randomization. The secondary endpoints are cardiovascular events (ischemic stroke, myocardial infarct, and other vascular events), death, serious adverse events, new silent brain infarcts, and activity of daily life. The purpose of this study is to establish the best medical treatment in symptomatic IAS patients. This study will also provide important information for the future randomized controlled study to compare medical treatment alone and intravascular intervetnion (PTA and/or stenting) in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (1) Ischemic stroke after two weeks to six months from onset,
- (2) Responsible lesion identified on MRI,
- ( 3) Intracranial arterial stenosis >50% on MRA in the territory of responsible lesion,
- (4) Intracranial arterial stenosis in suproclinoid internal carotid arterry, M1 portion of midlle cerebral artery, or basilar artery,
- (5) Age of 45 to 85 years,
Key exclusion criteria (14 listed)
- (1) Patients with potential cardiac embolic sources,
- (2) Patients receiving cilostazol,
- (3) Patients on warfarin treatment,
- (4) Patients in whom MRI cannot be perfomed,
- (5) Patients in whom PTA or bypass surgery is planned,
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 |
|---|---|---|
| Asprin, Cilostazol | Drug | – |
Primary outcome
Progression of intracranial arterial stenosis after two years
3 secondary outcomes
Cardiovascular events (ischemic stroke, cardiac infarctin, and other vascular events ）,
death (stroke death, vascular death except for stroke ）,
serious adverse events, new silent brain infarcts, and degrees of activity of daily living.
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 Dec 2017.
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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.
Shinichiro Uchiyama, M.D. PhD principal investigator
Department of Neurology, Tokyo Women's Medical University School of Medicine
Nobuyuki Sakai, M.D. PhD principal investigator
Kobe City General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Asprin, Cilostazol in people with Cerebrovascular Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan 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 7 inclusion and 14 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 Dec 2017. 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 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?
Progression of intracranial arterial stenosis after two years. 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 19 Dec 2017.