Ischemic StrokePhase 4NCT01188824
The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)
A Phase 4 study testing Cilostazol in people with Ischemic Stroke, run by China Medical University Hospital.
Trial summary
The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with PAD in Taiwan. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 801 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Jul 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, age ≧50 years; for female patients, postmenopausal (defined as at least 2 years without menses) has to be confirmed.
- Ischemic stroke or transient ischemic attack patients who have been taking aspirin 100 mg, QD
- Neurologically and clinically stable at inclusion
- PAD (i.e. ankle-brachial index or ABI <1.0)
Who cannot join
- Patients unable to give informed consent
- Patients with history of any type of hemorrhagic stroke (intracerebral hemorrhage,subarachnoid hemorrhage, or others)
- Modified Rankin Scale >4
- Patients with history of dementia requiring institutional care
- Known brain tumor
- Known anemia (defined as hemoglobin <10.0 g/dL)
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- Known thrombocytopenia (defined as platelet count below 100,000/cm3)
- AST or ALT > 3 x Upper Normal Limit
- Calculated creatinine clearance < 30 ml/min according to the Copckroft formula)
- Known hemostasis or coagulation disorder
- Congestive heart failure, defined as a previous definitive diagnosis, or present symptoms of at least Category II of the NYHA classification system for CHF
- Revascularization of the lower limb arteries including bypass surgery, endovascular procedures
- Symptomatic PAD requiring treatment with cilostazol
- Known stenosis of the upper limb arteries that may affect the documentation of ABI
- Patients with known hypersensitivity to cilostazol
About this study
The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with PAD in Taiwan.
Read the detailed description
One thousand patients will be randomized to take cilostazol (500 patients) or placebo (500 patients) in parallel groups. Patients will be screened and evaluated on Visits 1 to assess their eligibility prior to randomization. The treatment period (Visit 1-6) will last 12 months and the patient will receive initial and follow-up evaluation (section 4.5) including history and physical examinations, and baseline and end of treatment ABI and carotid IMT assessments. Vascular events and death as well as adverse events including bleeding complications will also be recorded at intervals as detailed in section 4.5.
- Conditions
- Ischemic Stroke
- Being tested
- Cilostazol, placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Also called Pletaal®
100 mg, bid p.o.
placeboOther
1 tablet, bid
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Active comparator | Pletaal® (Cilostazol) 100 mg, bid p.o. Receives: Drug: Cilostazol |
| placebo | Placebo comparator | Placebo
1 tablet, bid p.o. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for this study is slowdown of PAD progression based on ABI.
Measured: 2 years
Secondary outcomes (1)
Carotid intima-media thickness
- Carotid intima-media thickness.
- Vascular events, including recurrent stroke, myocardial infarction, unstable angina,other vascular events, and all death.
- Safety, including major bleeding events, hemorrhagic stroke, any death.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Tri-Service General Hospital (TSGH), Far Eastern Memorial Hospital, Changhua Christian Hospital, Chi Mei Medical Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, E-DA Hospital, Mackay Memorial Hospital, Cathay General Hospital, En Chu Kong Hospital, Kuang Tien General Hospital, Chung Shan Medical University, Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chung Y. Hsu, MD. Ph.D., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188824
- Sponsor's protocol ID
- DMR99-IRB-137
- Status last verified
- Jul 2013
- First submitted
- 23 Aug 2010
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)
- ClinicalTrials.gov ID
- NCT01188824
- Acronym / sponsor ID
- DMR99-IRB-137
- Conditions
- Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Tri-Service General Hospital (TSGH), Far Eastern Memorial Hospital, Changhua Christian Hospital, Chi Mei Medical Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, E-DA Hospital, Mackay Memorial Hospital, Cathay General Hospital, En Chu Kong Hospital, Kuang Tien General Hospital, Chung Shan Medical University, Taipei Veterans General Hospital, Taiwan
- Study start
- Sep 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Aug 2010 (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 investigate the Safety and Efficacy of Cilostazol in slowing down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with PAD in Taiwan.
Detailed description
One thousand patients will be randomized to take cilostazol (500 patients) or placebo (500 patients) in parallel groups. Patients will be screened and evaluated on Visits 1 to assess their eligibility prior to randomization. The treatment period (Visit 1-6) will last 12 months and the patient will receive initial and follow-up evaluation (section 4.5) including history and physical examinations, and baseline and end of treatment ABI and carotid IMT assessments. Vascular events and death as well as adverse events including bleeding complications will also be recorded at intervals as detailed in section 4.5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | Active comparator | Drug: CilostazolPletaal® (Cilostazol) 100 mg, bid p.o. |
| placebo | Placebo comparator | Other: placeboPlacebo 1 tablet, bid p.o. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients, age ≧50 years; for female patients, postmenopausal (defined as at least 2 years without menses) has to be confirmed.
- Ischemic stroke or transient ischemic attack patients who have been taking aspirin 100 mg, QD
- Neurologically and clinically stable at inclusion
- PAD (i.e. ankle-brachial index or ABI <1.0)
Key exclusion criteria (15 listed)
- Patients unable to give informed consent
- Patients with history of any type of hemorrhagic stroke (intracerebral hemorrhage,subarachnoid hemorrhage, or others)
- Modified Rankin Scale >4
- Patients with history of dementia requiring institutional care
- Known brain tumor
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 |
|---|---|---|
| CilostazolAlso: Pletaal®100 mg, bid p.o. | Drug | Cilostazol |
| placebo1 tablet, bid | Other | placebo |
Primary outcome
The primary endpoint for this study is slowdown of PAD progression based on ABI.
Time frame: 2 years
1 secondary outcome
Carotid intima-media thickness
Time frame: 2 years
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 7 Oct 2013.
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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.
Chung Y. Hsu, MD. Ph.D. principal investigator
China Medical University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cilostazol in people with Ischemic Stroke, run by China Medical University Hospital.
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 4 inclusion and 15 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 7 Oct 2013. 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. Some participants in this study may receive a placebo. 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?
The primary endpoint for this study is slowdown of PAD progression based on ABI. (time frame: 2 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 7 Oct 2013.