Vascular DementiaPhase 4CAVADNCT00847860
Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions
A Phase 4 study testing Cilostazol and Aspirin in people with Vascular Dementia and Stroke, run by Peking University First Hospital at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Vascular Dementia, Stroke
- What is being tested?
- Cilostazol and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2008to Jun 2011
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranging from 40 to 80 years
- After newly ischemic stroke from 3 months to 2 years
- Brain CT or MRI shows stroke lesions and white matter lesions, ARWMC(Age Related White Matter Change)>=4
- Moderate or mild cognitive deficits: MMSE 12-26
- Vascular or mixed dementia: Hachinski ischemic score>4
- Moderate or mild disability: MRS<=4,NIHSS<20
- Informed consent
Who cannot join
- Definitive diagnosis of dementia prior to the stroke
- Cerebral hemorrhage in the past
- Cerebral embolism result from cardiogenic embolus
- Critically ills: MRS>4,NIHSS>=20
- Bed-ridden patient who is hardly discovered newly stroke
- patient with sever cardiac, hepatic or nephric complication
Show all 12Show fewer
- dementia caused not by vascular lesions
- other diseases disturb the cognitive evaluation
- susceptibility to varieties of allergen
- abstain from Cilostazol or Asprin
- antiplatelet treatment, anticoagulation or fibrinolysis are needed because of other diseases
- rejected to participate by the patient or the family
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Shanghai Hua Shan Hospital
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White
The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors.
- Conditions
- Vascular Dementia, Stroke
- Being tested
- Cilostazol, Aspirin
- Keywords
- cognition
- Medical subject headings
- Dementia, Vascular, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Cilostazol 100 mg bid for 12 months
AspirinDrug
Aspirin 100 mg qd for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cilostazol Receives: Drug: Cilostazol |
| 2 | Active comparator | Asprin Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth
Measured: one year
Secondary outcomes (1)
stroke recurrence, other vascular ischemic events, bleeding events
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2011
- Study completionJun 2011
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 Vascular DementiaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Huang Yining, MD PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847860
- Sponsor's protocol ID
- Neurology-2008-VD
- Acronym
- CAVAD
- Status last verified
- Dec 2009
- First submitted
- 17 Feb 2009
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kwan J, Hafdi M, Chiang LLW, Myint PK, Wong LS, Quinn TJ. Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD012269. doi: 10.1002/14651858.CD012269.pub2.
PubMed 35833913
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White
- ClinicalTrials.gov ID
- NCT00847860
- Acronym / sponsor ID
- CAVAD / Neurology-2008-VD
- Conditions
- Vascular Dementia, Stroke
- Keywords
- cognition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Otsuka Pharmaceutical Co., Ltd.
- Study start
- Mar 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Feb 2009 (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 evaluate the efficacy of PDE-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CilostazolCilostazol |
| 2 | Active comparator | Drug: AspirinAsprin |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ranging from 40 to 80 years
- After newly ischemic stroke from 3 months to 2 years
- Brain CT or MRI shows stroke lesions and white matter lesions, ARWMC(Age Related White Matter Change)>=4
- Moderate or mild cognitive deficits: MMSE 12-26
- Vascular or mixed dementia: Hachinski ischemic score>4
Key exclusion criteria (12 listed)
- Definitive diagnosis of dementia prior to the stroke
- Cerebral hemorrhage in the past
- Cerebral embolism result from cardiogenic embolus
- Critically ills: MRS>4,NIHSS>=20
- Bed-ridden patient who is hardly discovered newly stroke
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 |
|---|---|---|
| CilostazolCilostazol 100 mg bid for 12 months | Drug | 1 |
| AspirinAspirin 100 mg qd for 12 months | Drug | 2 |
Primary outcome
changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth
Time frame: one year
1 secondary outcome
stroke recurrence, other vascular ischemic events, bleeding events
Time frame: one year
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 6 May 2015.
- Derived from this study: PubMed 35833913Kwan J, Hafdi M, Chiang LLW, Myint PK, Wong LS, Quinn TJ. Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD012269. doi: 10.1002/14651858.CD012269.pub2.
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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.
Huang Yining, MD PhD principal investigator
Peking University First Hospital
2 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 Cilostazol and Aspirin in people with Vascular Dementia and Stroke, run by Peking University First Hospital at 2 sites in China.
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 12 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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth (time frame: one year). 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 NCT00847860, 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 6 May 2015.