StrokePhase 3CLARITY-AfricaNCT06919835
CiLostAzol for pReventIon of Recurrent sTroke in Africa
A Phase 3 study testing Cilostazol 100 mg in people with Stroke, run by Northern California Institute of Research and Education at 1 site in Ghana.
Trial summary
Global estimates suggest that sub-Saharan Africa (SSA) now has the highest incidence, prevalence, and worst survival outcomes of stroke. With an estimated 1.4 million stroke survivors, outcomes of stroke in SSA are abysmal with 1-month case fatality at 30% and 3-year mortality rate of 84%. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cilostazol 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteGhana
- Study dates
- 1 Aug 2026to 31 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above the age of 30 years; male or female (sex is a biological variable of interest)
- Ischemic stroke or high-risk TIA (ABCD2 score >= 6) diagnosis no greater than six months before enrollment. Ischemic strokes including lacunar, large vessel atherosclerotic, embolic stroke of undetermined source subtypes are eligible (Ischemic stroke or TIA should be confirmed by either with a cranial CT or MRI within 10 days of symptom onset)
- Aspirin or clopidogrel monotherapy
- Subjects with stroke may present with two or more of the following additional conditions: age ≥65 years, documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension >140/90mmHg or previous treatment with anti-hypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction
- Legally competent to sign informed consent or have a LARs who is able to provide consent for them
- In the opinion of the treating physician, patient is medically stable, capable of participating in a randomized trial, and willing and able to attend follow-up.
- Able to do labs at all study intervals (7 visits total)
Who cannot join
- Unable to provide a valid informed consent
- Contraindications to cilostazol (namely (i) hypersensitivity, (ii) active pathologic bleeding, e.g. bleeding peptic ulcer, intracranial bleeding due to reversible platelet aggregation, (iii) congestive cardiac failure.)
- Hemorrhagic stroke survivor within the last 2 years
- Use of an anticoagulant medication or indication for use of an anticoagulant (e.g. atrial fibrillation)
- On dual antiplatelet therapy (patients are eligible after completion of a course of dual antiplatelet therapy)
- Modified Rankin Scale 5
Show all 10Show fewer
- Thrombocytopenia (platelet count <1000,000)
- Severe liver dysfunction (active hepatitis or hepatic insufficiency with Child-Pugh score B or C)
- Congestive heart failure, defined as NYHA Class III or above (marked limitation of physical activity)
- Nursing/pregnant mothers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Raelle Tagge, MPH contact
Ghana1 site
Kwame Nkrumah University of Science & Technology
Kumasi
Fred Sarfo, MD, PhD, +233 32 206 0021, stephensarfo78@gmail.com
About this study
Global estimates suggest that sub-Saharan Africa (SSA) now has the highest incidence, prevalence, and worst survival outcomes of stroke. With an estimated 1.4 million stroke survivors, outcomes of stroke in SSA are abysmal with 1-month case fatality at 30% and 3-year mortality rate of 84%. Stroke survivors in Africa are at an inordinately high (and worsening) risk of adverse outcomes including recurrent stroke and cardiac events over the medium- to longterm. Given the paucity of resources in the region, testing of therapies, which are potentially highly clinically efficacious and cost-effective, while developing local stroke research capacity and contributing to the global secondary stroke prevention evidence base, is urgently needed. Cilostazol, a phosphodiesterase 3 inhibitor, has shown promising efficacy and safety mainly among an Asian population by cutting risk of major adverse cardiovascular events including stroke, in half, when added to aspirin or clopidogrel (8% vs. 4%, HR 0.52, 95% CI 0.35-0.77), with no increased risk in bleeding or serious adverse events. Cilostazol's potentially strong efficacy, presumed pleiotropic effects, and relatively low cost, make it a highly appealing agent for use in stroke-prone, low-resource settings. Therefore, the overall objective of the CiLostAzol for pReventIon of recurrent sTroke in Africa (CLARITY-AFRICA) study is to deploy a hybrid study design to demonstrate the efficacy and safety of cilostazol twice daily in reducing MACE over 24 months vs. placebo among 1100 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, CLARITY-AFRICA also seeks to develop an implementation strategy for routine integration and policy adoption of cilostazol for post-stroke cardiovascular risk reduction in an under-resourced system. Given its compelling efficacy among a predominantly Asian population, the National Institute of Neurological Disorders and Stroke (NINDS) is poised to fund a US-based clinical trial to assess the longer-term efficacy and safety of cilostazol in a study titled CiLostAzol for pReventIon of recurrent sTroke (CLARITY). The investigators are also aware that European and Australian funding agencies are considering stroke trials of cilostazol. A concurrently executed CLARITYAfrica trial would allow recruitment of a historically underrepresented and high-risk group (Africans), test a therapy that if efficacious could be affordable for broader regional implementation, permit transcontinental mentorship/collaborations, and leverage NINDS impending investment. CLARITY-AFRICA will assess implementation outcomes such as adoption, acceptability, cost, pertinent to uptake of cilostazol in Ghana to inform policy. Regardless of its outcome, findings from CLARITYAFRICA will contribute meaningful information from the African perspective to inform the formulation of guidelines for global adoption of cilostazol into routine care for secondary CVD risk prevention by international bodies such as the World Health Organization. This application will focus on the first 2 aims of CLARITY-AFRICA to conduct the trial and assess secondary outcomes.
- Conditions
- Stroke
- Being tested
- Cilostazol 100 mg
- Keywords
- Stroke, Africa, post-stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol 100 mgDrug
Patients allocated to the experimental arm will receive 100mg of cilostazol tablets taken twice daily. To mitigate side-effects in both treatment arms, all patients will begin one tablet daily and titrate to the full dose (one tablet twice daily) after 2 weeks. Participants will stay on the full dose of cilostazol for the remainder of the study.
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol Experimental Arm | Experimental | Patients allocated to the experimental arm will receive 100mg of cilostazol tablets taken twice daily. To mitigate side-effects in both treatment arms, all patients will begin one tablet daily and titrate to the full dose (one tablet twice daily) after 2 weeks. Participants will stay on the full dose of cilostazol for the remainder of the study. Receives: Drug: Cilostazol 100 mg |
| Control Arm | No intervention | Standard of post-stroke care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants with Major Adverse Cardiovascular Events
Measured: 36 months
Secondary outcomes (8)
Percent of Participants with of Major and Minor bleeding
Measured: 24 months
Percent of Participants with Recurrent stroke (Ischemic or Hemorrhagic)
Measured: 24 months
Percent of Participants with Cardiovascular Deaths
Measured: 24 months
Percent of Participants with All Cause Mortality
Measured: 24 months
Neuro-QoL (Quality of Life)
12 monthly
Neuro-QoL uses T-scores, which are standardized scores:
Mean (average) = 50 Standard deviation = 10
Interpreting T-scores:
Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment Scores 2.0 SD or more worse than the mean = severe symptoms/impairment
For negative domains (e.g. anxiety, depression, fatigue):
Higher = Worse
We will compare mean Neuro-QoL scores between the two arms of the study at study completion as well as proportions with mild, moderate and severe impairment.
Measured: 24 months
Exploratory outcomes Montreal Cognitive Assessment
6 monthly. Comparison of Slopes of MOCA scores over 24 months. Range of scores on MOCA: 0 to 30.
MOCA screening tool is used to detect mild cognitive impairment and early signs of dementia. It evaluates several cognitive domains, including:
Memory Attention Language Visuospatial skills Executive function Orientation
A score of 26 or above is considered normal. Scores below 26 may suggest cognitive impairment, depending on education level and clinical context.
Measured: 24 months
Quality of Life (EQ-5D Questionnaire)
The EQ-5D is a health-related quality of life questionnaire with two parts:
Descriptive system: Assesses 5 dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on 3 or 5 levels (from no problems to extreme problems).
Visual Analog Scale (VAS): Rates overall health from 0 (worst) to 100 (best).
Scoring:
The 5-digit health state is converted into a summary index score (range: <0 to 1), with 1 = full health.
The VAS reflects the person's self-rated health.
We will compare scores between the two arms at study completion.
Measured: 24 months
Modified Rankin Score
The Modified Rankin Scale (mRS) measures the degree of disability or dependence in daily activities after a stroke or other neurological injury.
Scoring:
0 - No symptoms
- - No significant disability; able to carry out all usual activities
- - Slight disability; unable to do all previous activities but able to look after own affairs
- - Moderate disability; needs some help but can walk unassisted
- - Moderately severe disability; unable to walk or attend to bodily needs without help
- - Severe disability; bedridden, incontinent, requires constant care
- - Dead
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern California Institute of Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Ovbiagele, Northern California Institute of Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919835
- Sponsor's protocol ID
- 24-41599
- Acronym
- CLARITY-Africa
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant level data will be aggregated and maintained as de-identified to protect PHI
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CiLostAzol for pReventIon of Recurrent sTroke in Africa
- ClinicalTrials.gov ID
- NCT06919835
- Acronym / sponsor ID
- CLARITY-Africa / 24-41599
- Conditions
- Stroke
- Keywords
- Stroke, Africa, post-stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Northern California Institute of Research and EducationUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 9 Apr 2025 (actual)
- 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.
Global estimates suggest that sub-Saharan Africa (SSA) now has the highest incidence, prevalence, and worst survival outcomes of stroke. With an estimated 1.4 million stroke survivors, outcomes of stroke in SSA are abysmal with 1-month case fatality at 30% and 3-year mortality rate of 84%. Stroke survivors in Africa are at an inordinately high (and worsening) risk of adverse outcomes including recurrent stroke and cardiac events over the medium- to longterm. Given the paucity of resources in the region, testing of therapies, which are potentially highly clinically efficacious and cost-effective, while developing local stroke research capacity and contributing to the global secondary stroke prevention evidence base, is urgently needed. Cilostazol, a phosphodiesterase 3 inhibitor, has shown promising efficacy and safety mainly among an Asian population by cutting risk of major adverse cardiovascular events including stroke, in half, when added to aspirin or clopidogrel (8% vs. 4%, HR 0.52, 95% CI 0.35-0.77), with no increased risk in bleeding or serious adverse events. Cilostazol's potentially strong efficacy, presumed pleiotropic effects, and relatively low cost, make it a highly appealing agent for use in stroke-prone, low-resource settings. Therefore, the overall objective of the CiLostAzol for pReventIon of recurrent sTroke in Africa (CLARITY-AFRICA) study is to deploy a hybrid study design to demonstrate the efficacy and safety of cilostazol twice daily in reducing MACE over 24 months vs. placebo among 1100 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, CLARITY-AFRICA also seeks to develop an implementation strategy for routine integration and policy adoption of cilostazol for post-stroke cardiovascular risk reduction in an under-resourced system. Given its compelling efficacy among a predominantly Asian population, the National Institute of Neurological Disorders and Stroke (NINDS) is poised to fund a US-based clinical trial to assess the longer-term efficacy and safety of cilostazol in a study titled CiLostAzol for pReventIon of recurrent sTroke (CLARITY). The investigators are also aware that European and Australian funding agencies are considering stroke trials of cilostazol. A concurrently executed CLARITYAfrica trial would allow recruitment of a historically underrepresented and high-risk group (Africans), test a therapy that if efficacious could be affordable for broader regional implementation, permit transcontinental mentorship/collaborations, and leverage NINDS impending investment. CLARITY-AFRICA will assess implementation outcomes such as adoption, acceptability, cost, pertinent to uptake of cilostazol in Ghana to inform policy. Regardless of its outcome, findings from CLARITYAFRICA will contribute meaningful information from the African perspective to inform the formulation of guidelines for global adoption of cilostazol into routine care for secondary CVD risk prevention by international bodies such as the World Health Organization. This application will focus on the first 2 aims of CLARITY-AFRICA to conduct the trial and assess secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol Experimental Arm | Experimental | Drug: Cilostazol 100 mgPatients allocated to the experimental arm will receive 100mg of cilostazol tablets taken twice daily. To mitigate side-effects in both treatment arms, all patients will begin one tablet daily and titrate to the full dose (one tablet twice daily) after 2 weeks. Participants will stay on the full dose of cilostazol for the remainder of the study. |
| Control Arm | No intervention | –Standard of post-stroke care |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Above the age of 30 years; male or female (sex is a biological variable of interest)
- Ischemic stroke or high-risk TIA (ABCD2 score >= 6) diagnosis no greater than six months before enrollment. Ischemic strokes including lacunar, large vessel atherosclerotic, embolic stroke of undetermined source subtypes are eligible (Ischemic stroke or TIA should be confirmed by either with a cranial CT or MRI within 10 days of symptom onset)
- Aspirin or clopidogrel monotherapy
- Subjects with stroke may present with two or more of the following additional conditions: age ≥65 years, documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension >140/90mmHg or previous treatment with anti-hypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction
- Legally competent to sign informed consent or have a LARs who is able to provide consent for them
Key exclusion criteria (10 listed)
- Unable to provide a valid informed consent
- Contraindications to cilostazol (namely (i) hypersensitivity, (ii) active pathologic bleeding, e.g. bleeding peptic ulcer, intracranial bleeding due to reversible platelet aggregation, (iii) congestive cardiac failure.)
- Hemorrhagic stroke survivor within the last 2 years
- Use of an anticoagulant medication or indication for use of an anticoagulant (e.g. atrial fibrillation)
- On dual antiplatelet therapy (patients are eligible after completion of a course of dual antiplatelet therapy)
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 |
|---|---|---|
| Cilostazol 100 mgPatients allocated to the experimental arm will receive 100mg of cilostazol tablets taken twice daily. To mitigate side-effects in both treatment arms, all patients will begin one tablet daily and titrate to the full dose (one tablet twice daily) after 2 weeks. Participants will stay on the full dose of cilostazol for the remainder of the study. | Drug | Cilostazol Experimental Arm |
Primary outcome
Percent of Participants with Major Adverse Cardiovascular Events
Time frame: 36 months
8 secondary outcomes
Percent of Participants with of Major and Minor bleeding
Time frame: 24 months
Percent of Participants with Recurrent stroke (Ischemic or Hemorrhagic)
Time frame: 24 months
Percent of Participants with Cardiovascular Deaths
Time frame: 24 months
Percent of Participants with All Cause Mortality
Time frame: 24 months
Neuro-QoL (Quality of Life)
Time frame: 24 months
Exploratory outcomes Montreal Cognitive Assessment
Time frame: 24 months
Quality of Life (EQ-5D Questionnaire)
Time frame: 24 months
Modified Rankin Score
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant level data will be aggregated and maintained as de-identified to protect PHI
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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.
Raelle Tagge, MPH contact
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 Cilostazol 100 mg in people with Stroke, run by Northern California Institute of Research and Education at 1 site in Ghana.
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 10 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: opening soon, as of the sponsor's last update on 18 Jun 2026. 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 Ghana. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruce Ovbiagele, M.D., MSc, MAS, MBA (415-750-2047, bruce.ovbiagele@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants with Major Adverse Cardiovascular Events (time frame: 36 months). 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 18 Jun 2026.