StrokePhase 3NCT05963568
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
A Phase 3 study testing Polycap in people with Stroke and Medication Adherence, run by Northern California Institute of Research and Education at 4 sites in 4 countries.
Trial summary
The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Medication Adherence
- What is being tested?
- Polycap
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Apr 2026to 1 Feb 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above the age of 18 years; male or female
- Ischemic stroke diagnosis no greater than two months before enrollment. Ischemic strokes including� lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible
- Subjects with stroke may present with at least one of the following additional conditions:
- Documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension >140/90mmHg or previous treatment with antihypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction
- Legally competent to sign informed consent.
Who cannot join
- Unable to sign informed consent
- Contraindications to any of the components of the polypill
- Hemorrhagic stroke
- Severe cognitive impairment/dementia or severe global disability limiting the capacity of self-care
- Severe congestive cardiac failure (NYHA III-IV)
- Severe renal disease, eGFR <30ml/min/1.73m2), renal dialysis; awaiting renal transplant or transplant recipient
Show all 11Show fewer
- Cancer diagnosis or treatment in past 2 years
- Need for oral anticoagulation at the time of randomization or planned in the future months;
- Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation)
- Nursing/pregnant mothers
- Do not agree to the filing, forwarding and use of his/her pseudonymized data.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Raelle Tagge, MPH contact
4 sites in 4 countries
Benin1 site, 1 recruiting
- Recruiting
University Teaching Hospital of Parakou
Parakou
Thierry Adokounou, +229 90972012, adoukonouthierry@yahoo.fr
Ghana1 site
- Active, not recruiting
Kwame Nkrumah Institute of Science & Technology
Kumasi
Nigeria1 site, 1 recruiting
- Recruiting
University of Ilorin Teaching Hospital
Ilorin
Kolawole Wahab, +234 806 816 6475, kwwahab@yahoo.com
Tanzania1 site, 1 recruiting
- Not yet recruiting
Aga Khan Hospital
Dar es Salaam
Sarah Matuja, +255 22 234 4100, dr.matujajunior@gmail.com
About this study
The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 1000 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.
- Conditions
- Stroke, Medication Adherence
- Being tested
- Polycap
- Medical subject headings
- Stroke, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolycapDrug
Patients allocated to the experimental arm will receive Two (2) (Polycap ®) taken orally once a day. A capsule of Polycap ® contains 100mg of Aspirin, 20mg of simvastatin, 12.5mg hydrochlorothiazide, 5mg of ramipril and 50mg of atenolol. Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn and replaced with the Polypill if they are already receiving such treatments before enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients allocated to the experimental arm will receive Two (2) (Polycap ®) taken orally once a day. A capsule of Polycap ® contains 100mg of Aspirin, 20mg of simvastatin, 12.5mg hydrochlorothiazide, 5mg of ramipril and 50mg of atenolol. Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn \& replaced with the Polypill if they are already receiving such treatments before enrollment. Receives: Drug: Polycap |
| Control arm | No intervention | Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention with drugs and doses left at the discretion of the treating physicians. Since our focus is to isolate the effect of the polypill strategy itself \& create equipoise, at study inception providers for patients in both study arms will receive a brief one-time (Skype-based) training \& a one time email synopsis on guideline recommended biomarker targets after stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite vascular risk factor control
Proportion of people who have 0, 1, 2 and 3 of the following: systolic BP <140 mm Hg, LDL-cholesterol <100mg/dl, antiplatelet adherence by pill count >90%) at month 12 and month 24 (sustainment of effect)
Measured: 12 and 24 months
Secondary outcomes (5)
Major adverse cardiovascular events (MACE)
MACE to be assessed include recurrent stroke: fatal/severely disabling stroke or non-fatal stroke; coronary artery disease: acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudication committee by reviewing available clinical notes supported by investigations for example CT scans, EKGs, troponin tests, death certificates or verbal autopsy if death occurs outside hospital.
Measured: 24 months
Change in adherence to medical therapy
Measured: Month 3, 6, 9, 12, 18 & 24
Safety and tolerability
Side effects, adverse events, treatment withdrawal
Measured: Up to 24 months
Health-related quality of life EuroQol-5D
EuroQol-5D questionnaire (0-100 with 100 being the best)
Measured: Up to 24 months
Health-related quality of life Neuro-QoLTM
NINDS Neuro-QoLTM (Quality of Life in Neurological Disorders) questionnaires (8-40 with 40 being the best)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Apr 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
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 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 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
- NCT05963568
- Sponsor's protocol ID
- 22-37310
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sarfo FS, Wahab K, Matuja SS, Adebayo PB, Adoukonou T, Tagge R, Ovbiagele B. Stroke minimization through additive anti-atherosclerotic agents in routine treatment (SMAART) II: Rationale for a multi-country polypill phase 3 trial in sub-Saharan Africa. Equity Neurosci. 2026 Apr;2(1):100020. doi: 10.1016/j.neuros.2026.100020. Epub 2026 Jan 22.
PubMed 41727852
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
- ClinicalTrials.gov ID
- NCT05963568
- Acronym / sponsor ID
- 22-37310
- Conditions
- Stroke, Medication Adherence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Northern California Institute of Research and EducationUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 27 Jul 2023 (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.
The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 1000 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: PolycapPatients allocated to the experimental arm will receive Two (2) (Polycap ®) taken orally once a day. A capsule of Polycap ® contains 100mg of Aspirin, 20mg of simvastatin, 12.5mg hydrochlorothiazide, 5mg of ramipril and 50mg of atenolol. Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn \& replaced with the Polypill if they are already receiving such treatments before enrollment. |
| Control arm | No intervention | –Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention with drugs and doses left at the discretion of the treating physicians. Since our focus is to isolate the effect of the polypill strategy itself \& create equipoise, at study inception providers for patients in both study arms will receive a brief one-time (Skype-based) training \& a one time email synopsis on guideline recommended biomarker targets after stroke. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Above the age of 18 years; male or female
- Ischemic stroke diagnosis no greater than two months before enrollment. Ischemic strokes including� lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible
- Subjects with stroke may present with at least one of the following additional conditions:
- Documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension >140/90mmHg or previous treatment with antihypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction
- Legally competent to sign informed consent.
Key exclusion criteria (11 listed)
- Unable to sign informed consent
- Contraindications to any of the components of the polypill
- Hemorrhagic stroke
- Severe cognitive impairment/dementia or severe global disability limiting the capacity of self-care
- Severe congestive cardiac failure (NYHA III-IV)
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 |
|---|---|---|
| PolycapPatients allocated to the experimental arm will receive Two (2) (Polycap ®) taken orally once a day. A capsule of Polycap ® contains 100mg of Aspirin, 20mg of simvastatin, 12.5mg hydrochlorothiazide, 5mg of ramipril and 50mg of atenolol. Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn and replaced with the Polypill if they are already receiving such treatments before enrollment. | Drug | Intervention |
Primary outcome
Composite vascular risk factor control
Time frame: 12 and 24 months
Proportion of people who have 0, 1, 2 and 3 of the following: systolic BP <140 mm Hg, LDL-cholesterol <100mg/dl, antiplatelet adherence by pill count >90%) at month 12 and month 24 (sustainment of effect)
5 secondary outcomes
Major adverse cardiovascular events (MACE)
Time frame: 24 months
Change in adherence to medical therapy
Time frame: Month 3, 6, 9, 12, 18 & 24
Safety and tolerability
Time frame: Up to 24 months
Health-related quality of life EuroQol-5D
Time frame: Up to 24 months
Health-related quality of life Neuro-QoLTM
Time frame: Up to 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 6 Jul 2026.
- Derived from this study: PubMed 41727852Sarfo FS, Wahab K, Matuja SS, Adebayo PB, Adoukonou T, Tagge R, Ovbiagele B. Stroke minimization through additive anti-atherosclerotic agents in routine treatment (SMAART) II: Rationale for a multi-country polypill phase 3 trial in sub-Saharan Africa. Equity Neurosci. 2026 Apr;2(1):100020. doi: 10.1016/j.neuros.2026.100020. Epub 2026 Jan 22.
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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
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polycap in people with Stroke and Medication Adherence, run by Northern California Institute of Research and Education at 4 sites in 4 countries.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Benin, Ghana, Nigeria, Tanzania. 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, MD (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?
Composite vascular risk factor control (time frame: 12 and 24 months). 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 NCT05963568, 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 Jul 2026.