A Phase 3 interventional study of Polycap in Stroke and Medication Adherence, sponsored by Northern California Institute of Research and Education. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Northern California Institute of Research and Education · Phase 3, Interventional, and Prevention
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Northern California Institute of Research and Education is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 ( 60-30ml/min/1.73m2); Prior myocardial infarction
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Polycap
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.
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.
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)
Time frame: 12 and 24 months
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.
Time frame: 24 months
Change in adherence to medical therapy
Time frame: Month 3, 6, 9, 12, 18 & 24
Safety and tolerability
Side effects, adverse events, treatment withdrawal
Time frame: Up to 24 months
Health-related quality of life EuroQol-5D
EuroQol-5D questionnaire (0-100 with 100 being the best)
Time frame: 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)
Time frame: Up to 24 months
Organizational Capacity for Change Score
Adoption i.e. Organizational Capacity for Change (OCC Scale Score comparison) with stratification by level of healthcare delivery. The measure is a 32-item multidimensional scale that evaluates an organization's capacity to upgrade or revise existing organizational competencies, while cultivating new competencies that enable the organization to survive and prosper. It comprises different aspects of leadership, employee behavior, and an organizational infrastructure supporting organizational change. Items are rated on a 5-point Likert scale. OCC has a Cronbach α of 0.87.
Time frame: Up to 30 months
Mean Cost of Implementation
Implementation Cost (mean monthly health expenses compared to standard of care)
Time frame: Up to 30 months
Proportion who achieves systolic blood pressure <140 mmHg
Time frame: Months 12 and 24
Proportion who achieves blood pressure <140/90 mmHg
Time frame: Months 12 and 24
Proportion who achieves blood pressure < 130 / 80 mmHg
Time frame: Months 12 and 24
Proportion who achieves LDL-cholesterol <100 mg/dl
Time frame: Months 12 and 24
Proportion who achieves LDL-cholesterol <70 mg/dl
Time frame: Months 12 and 24
Proportion who achieves antiplatelet adherence of at least >=80%
Time frame: Months 12 and 24
Proportion who achieves antiplatelet adherence of at least >= 90%
Time frame: Months 12 and 24
Comparison of absolute and mean changes from baseline for blood pressure
systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, measures of visit-to-visit variability in blood pressure
Time frame: Up to 24 months
Comparison of absolute and mean changes from baseline for lipids
Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglyceride
Time frame: Up to 24 months
Proportion with recurrent strokes (fatal or non-fatal)
Time frame: Up to 24 months
Proportion with coronary artery disease
Time frame: Up to 24 months
Proportion with heart failure
Time frame: Up to 24 months
Proportion with cardiovascular deaths
Time frame: Up to 24 months
Proportion with all-cause mortality
Time frame: Up to 24 months
Proportion with vascular cognitive impairment
Time frame: Months 12 and 24
Proportion with treatment-limiting adverse drug reactions or side effects
Time frame: Up to 24 months
Not enrolling at this site.
Started Apr 2026 (actual). Primary completion is estimated for Jan 2029, 33 months after the start.
Of 92 non-industry phase 3 interventional studies under Stroke, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's planned 33 months is below that.
Counting every sponsor, half of 129 studies reached it within 44 months; a quarter within 27 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Aspirin/Simvastatin/Atenolol/Ramipril/Thiazide Capsule
Northern California Institute of Research and Education