A Phase 2 interventional study of Polycap in Atherosclerosis, Adherence, Medication and Tolerance, sponsored by Northern California Institute of Research and Education. Completed at 1 site in Ghana. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by Northern California Institute of Research and Education · Phase 2, Interventional, and Treatment
The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is to assess whether a polypill containing fixed doses of (2/3) antihypertensives, a statin and antiplatelet therapy taken once daily orally would result in carotid intimal thickness regression-a surrogate marker of atherosclerosis, improved adherence, and tolerability compared with 'usual care' group on separate individual secondary preventive medications among Ghanaian first time stroke survivors. Our ultimate objective is to design of a future multi center, double-blinded, placebo-controlled, parallel-group, randomized trial comparing the clinical efficacy of the polypill strategy vs 'usual care' in the African context to derive locally relevant, high-quality evidence for routine deployment of polypill for CVD risk moderation among stroke survivors in LMICs. In this current study, we plan to recruit 120 recent ischemic stroke survivors randomized 1:1 to the polypill or usual care arms.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's enrollment of 148 is above the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis 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.
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.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule
Drug: Polycap
Will continue to take separate, individual secondary preventive medications as prescribed
Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule
Carotid Intimal Media Thickness
Thickness of the intima and media layers of the carotid arteries
Time frame: Baseline and 12 months
Morisky Adherence Scale Score
The Morisky Medication Adherence Scale (MMAS-8) is a validated assessment tool used to measure non-adherence in a variety of patient populations. The scale has been verified and substantiated by numerous studies on a global scale with over 110 versions and over 80 translations. The MMAS-8 is an 8-item structured, self-report measure. Total scores on the MMAS-8 range from 0 to 8, with scores of: 8 reflecting high adherence 7 or 6 reflecting medium adherence \<6 reflecting low adherence. 0 is the worst and 8 is the best.
Time frame: 12 months
Hill-Bone Score
The Hill-Bone Compliance to High Blood Pressure Therapy Scale is a 14-item scale that assesses patient behaviors for three important behavioral domains of high blood pressure treatment. (the three sub-scales of the original scale): Appointment Keeping (3-items), Diet (2-items), Medication Adherence (9-items). The scale has a four point response format: (4) all the time, (3) most of time, (2) some of time, and (1) never. Items are assumed to be additive, and, when summed, the total score ranges from 14 (minimum) to 56. 14 is the worst and 56 is the best.
Time frame: 12 months
EQ-5D Quality-of-Life Score
The EQ-5D is a self-report survey that measures health-related quality of life. It consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Each dimension has five response levels: No problems (Level 1) Slight Moderate Severe Extreme problems (Level 5) The EQ-5D also has a VAS scale from 0 (worst imaginable health state) to 100 (best imaginable health state). An individual records a score between 0 and 100 for their current overall health-related quality of life using the EQ VAS.
Time frame: 12 months
Treatment Satisfaction Questionnaire for Medication Score
The Treatment Satisfaction Questionnaire for Medication (TSQM) has scores that range from 0 to 100. Higher scores indicate higher patient satisfaction with medication. 0 is the worst, 100 is the best. The TSQM has 14 items and four domains: Effectiveness: Three items Side effects: Five items Convenience: Three items Global satisfaction: Three items The TSQM has a recall period of two to three weeks or since the last medication use. It was designed to assess patient treatment satisfaction in chronic diseases.
Time frame: 12 months
Montreal Cognitive Assessment Score
The Montreal Cognitive Assessment (MoCA) is a cognitive screening test that can detect dementia and mild cognitive impairment. The test consists of 11 questions that evaluate seven cognitive domains. The maximum score is 30. 26 or higher: Normal 18-25: Mild cognitive impairment 10-17: Moderate impairment Less than 10: Severe impairment. 0 is the worst, 30 is the best.
Time frame: 12 months
Modified Rankin Score
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. 0 is the best, 5 is the worst.
Time frame: 12 months
Hamilton Rating Scale for Depression Score
The Hamilton Rating Scale for Depression (HRSD) is a 21-item scale that is administered by a health care professional. The first 17 items are scored on either a 5-point or 3-point scale. The scale takes 15 to 20 minutes to complete and score. 0-7: No depression 8-16: Mild depression 17-23: Moderate depression 0 is the best, 23 is the worst. ≥24: Severe depression
Time frame: 12 months
| Milestone | Polypill | Usual Care |
|---|---|---|
| Started | 74 | 74 |
| Completed | 59 | 64 |
| Not completed | 15 | 10 |
Thickness of the intima and media layers of the carotid arteries
| mm | Polypill | Usual Care |
|---|---|---|
| Carotid Intimal Media Thickness | -0.017 (-0.067 to 0.034) | -0.092 (-0.130 to -0.051) |
The Morisky Medication Adherence Scale (MMAS-8) is a validated assessment tool used to measure non-adherence in a variety of patient populations. The scale has been verified and substantiated by numerous studies on a global scale with over 110 versions and over 80 translations. The MMAS-8 is an 8-item structured, self-report measure. Total scores on the MMAS-8 range from 0 to 8, with scores of: 8 reflecting high adherence 7 or 6 reflecting medium adherence \<6 reflecting low adherence. 0 is the worst and 8 is the best.
| score on a scale | Polypill | Usual Care |
|---|---|---|
| Morisky Adherence Scale Score | -0.19 (-0.48 to 0.10) | -0.14 (-0.53 to 0.24) |
The Hill-Bone Compliance to High Blood Pressure Therapy Scale is a 14-item scale that assesses patient behaviors for three important behavioral domains of high blood pressure treatment. (the three sub-scales of the original scale): Appointment Keeping (3-items), Diet (2-items), Medication Adherence (9-items). The scale has a four point response format: (4) all the time, (3) most of time, (2) some of time, and (1) never. Items are assumed to be additive, and, when summed, the total score ranges from 14 (minimum) to 56. 14 is the worst and 56 is the best.
| score on a scale | Polypill | Usual Care |
|---|---|---|
| Hill-Bone Score | -0.51 (-1.37 to 0.36) | -1.11 (-2.31 to 0.09) |
The EQ-5D is a self-report survey that measures health-related quality of life. It consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Each dimension has five response levels: No problems (Level 1) Slight Moderate Severe Extreme problems (Level 5) The EQ-5D also has a VAS scale from 0 (worst imaginable health state) to 100 (best imaginable health state). An individual records a score between 0 and 100 for their current overall health-related quality of life using the EQ VAS.
| score on a scale | Polypill | Usual Care |
|---|---|---|
| EQ-5D Quality-of-Life Score | 7.63 (5.08 to 10.18) | 10.23 (8.00 to 12.47) |
The Treatment Satisfaction Questionnaire for Medication (TSQM) has scores that range from 0 to 100. Higher scores indicate higher patient satisfaction with medication. 0 is the worst, 100 is the best. The TSQM has 14 items and four domains: Effectiveness: Three items Side effects: Five items Convenience: Three items Global satisfaction: Three items The TSQM has a recall period of two to three weeks or since the last medication use. It was designed to assess patient treatment satisfaction in chronic diseases.
| score on a scale | Polypill | Usual Care |
|---|---|---|
| Treatment Satisfaction Questionnaire for Medication Score | -10.92 (-15.88 to -5.96) | -6.72 (-10.80 to -2.63) |
The Montreal Cognitive Assessment (MoCA) is a cognitive screening test that can detect dementia and mild cognitive impairment. The test consists of 11 questions that evaluate seven cognitive domains. The maximum score is 30. 26 or higher: Normal 18-25: Mild cognitive impairment 10-17: Moderate impairment Less than 10: Severe impairment. 0 is the worst, 30 is the best.
| score on a scale | Polypill | Usual Care |
|---|---|---|
| Montreal Cognitive Assessment Score | 5.17 (4.17 to 6.17) | 5.39 (4.13 to 6.64) |
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. 0 is the best, 5 is the worst.
| score on a scale | Polypill | Usual Care |
|---|---|---|
| Modified Rankin Score | -0.92 (-1.14 to -0.69) | -0.89 (-1.09 to -0.69) |
The Hamilton Rating Scale for Depression (HRSD) is a 21-item scale that is administered by a health care professional. The first 17 items are scored on either a 5-point or 3-point scale. The scale takes 15 to 20 minutes to complete and score. 0-7: No depression 8-16: Mild depression 17-23: Moderate depression 0 is the best, 23 is the worst. ≥24: Severe depression
| score on a scale | Polypill | Usual Care |
|---|---|---|
| Hamilton Rating Scale for Depression Score | -3.51 (-4.44 to -2.57) | -4.06 (-4.91 to -3.22) |
Collected over 1 year. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Polypill | 5/74 (6.8%) | 3/74 (4.1%) | 5/74 (6.8%) |
| Usual Care | 2/74 (2.7%) | 0/74 (0%) | 7/74 (9.5%) |
| Event | Polypill | Usual Care |
|---|---|---|
| Post-stroke seizuresVascular disorders | 2/74 | 0/74 |
| HospitalizationSurgical and medical procedures | 1/74 | 0/74 |
| Event | Polypill | Usual Care |
|---|---|---|
| Regimen AdjustmentsVascular disorders | 5/74 | 7/74 |
| Treatment DiscontinuationVascular disorders | 3/74 | 0/74 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/74 | 0/74 |
| Gatrointestinal BleedingGastrointestinal disorders | 1/74 | 0/74 |
| Age, Continuous(years) | Polypill | Usual Care | Total |
|---|---|---|---|
| Mean | 58.5 ± 10.7 | 58.1 ± 13.3 | 58.3 ± 12.07 |
| Sex: Female, Male(Participants) | Polypill | Usual Care | Total |
|---|---|---|---|
| Female | 38 | 36 | 74 |
| Male | 36 | 38 | 74 |
| Race (NIH/OMB)(Participants) | Polypill | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 74 | 74 | 148 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Polypill | Usual Care | Total |
|---|---|---|---|
| Ghana | 74 | 74 | 148 |
| Educational Status(Participants) | Polypill | Usual Care | Total |
|---|---|---|---|
| None | 11 | 15 | 26 |
| Primary | 42 | 28 | 70 |
| Secondary | 12 | 18 | 30 |
| Tertiary | 9 | 12 | 21 |
| Postgraduate | 0 | 1 | 1 |
| Urban Residence(Participants) | Polypill | Usual Care | Total |
|---|---|---|---|
| Count of participants | 42 | 37 | 79 |
| Marital Status(Participants) | Polypill | Usual Care | Total |
|---|---|---|---|
| Never married | 6 | 5 | 11 |
| Married | 43 | 47 | 90 |
| Separated | 12 | 5 | 17 |
| Widow or widower | 11 | 14 | 25 |
| Cohabiting | 0 | 1 | 1 |
| Divorced | 2 | 2 | 4 |
| Employment Status(Participants) | Polypill | Usual Care | Total |
|---|---|---|---|
| Employed | 54 | 45 | 99 |
| Retired | 11 | 10 | 21 |
| Unemployed | 9 | 19 | 28 |
30 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2019 to primary completion in Dec 2021, 33 months.
Results were first posted in Dec 2023, 2 years after primary completion.
Of 46 phase 2 interventional studies under Atherosclerosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's 33 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get 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