AtherosclerosisPhase 2NCT03329599
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
A Phase 2 study testing Polycap in people with Atherosclerosis and Adherence, Medication, run by Northern California Institute of Research and Education at 1 site in Ghana.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atherosclerosis, Adherence, Medication, Tolerance
- 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
- 148 participants
- Where
- 1 siteGhana
- Study dates
- 14 Feb 2019to 30 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Stroke/TIA 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 anti-hypertensive 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
1 site in 1 country.
About this study
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.
- Conditions
- Atherosclerosis, Adherence, Medication, Tolerance
- Being tested
- Polycap
- Medical subject headings
- Atherosclerosis, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolycapDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Polypill | Experimental | 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 Receives: Drug: Polycap |
| Usual Care | No intervention | Will continue to take separate, individual secondary preventive medications as prescribed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Intimal Media Thickness
Thickness of the intima and media layers of the carotid arteries
Measured: Baseline and 12 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start14 Feb 2019
- Primary completion1 Dec 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SMAART incorporates (i) a pilot randomized controlled trial and (ii) a human capital/institutional capacity building component. We propose a randomized, open label, blinded endpoint clinical trial with the intervention arm 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 compared with the 'usual care' arm who will continue to take separate, individual secondary preventive medications as prescribed their physicians to assess CIMT changes as a robust intermediary outcome measure for CVD events, as well as adherence, tolerability, and risk factor control rates. Furthermore, a cadre of emerging investigators from Ghana will benefit from the rich learning environment to be created through the implementation of the RCT and the interactions (2 years) with experts from the Medical University of South Carolina.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern California Institute of Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Kwame Nkrumah University Teaching Hospital
- Responsible party
- Principal investigator, Bruce Ovbiagele, Northern California Institute of Research and Education
- Investigators
- Jenifer Voeks, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329599
- Sponsor's protocol ID
- Pro00068785
- Status last verified
- Dec 2023
- First submitted
- 28 Aug 2017
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarfo FS, Adu-Gyamfi R, Opare-Addo PA, Agyei B, Ampofo M, Nguah SB, Ovbiagele B. Effect of a Cardiovascular Polypill on Poststroke Cognition Among Ghanaians: Secondary Analysis of a Randomized Clinical Trial. J Am Heart Assoc. 2024 Aug 6;13(15):e034346. doi: 10.1161/JAHA.124.034346. Epub 2024 Jul 31.
PubMed 39082406Sarfo FS, Voeks J, Adamu S, Agyei BA, Agbenorku M, Adu-Darko N, Oteng MA, Obese V, Gyamfi RA, Mensah NA, Tagge R, Ampofo M, Kontoh SA, Nguah SB, Ovbiagele B. A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trial. Lancet Glob Health. 2023 Oct;11(10):e1619-e1628. doi: 10.1016/S2214-109X(23)00347-9.
PubMed 37734804Sarfo FS, Sarfo-Kantanka O, Adamu S, Obese V, Voeks J, Tagge R, Sethi V, Ovbiagele B. Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial. Trials. 2018 Mar 14;19(1):181. doi: 10.1186/s13063-018-2564-0.
PubMed 29540234
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. 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
- ClinicalTrials.gov ID
- NCT03329599
- Acronym / sponsor ID
- Pro00068785
- Conditions
- Atherosclerosis, Adherence, Medication, Tolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Northern California Institute of Research and EducationUniversity, hospital or other
- Collaborators
- Kwame Nkrumah University Teaching Hospital
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SMAART incorporates (i) a pilot randomized controlled trial and (ii) a human capital/institutional capacity building component. We propose a randomized, open label, blinded endpoint clinical trial with the intervention arm 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 compared with the 'usual care' arm who will continue to take separate, individual secondary preventive medications as prescribed their physicians to assess CIMT changes as a robust intermediary outcome measure for CVD events, as well as adherence, tolerability, and risk factor control rates. Furthermore, a cadre of emerging investigators from Ghana will benefit from the rich learning environment to be created through the implementation of the RCT and the interactions (2 years) with experts from the Medical University of South Carolina.
| Arm | Type | Receives |
|---|---|---|
| Polypill | Experimental | Drug: PolycapAssigned 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 |
| Usual Care | No intervention | –Will continue to take separate, individual secondary preventive medications as prescribed |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above the age of 18 years; male or female
- Stroke/TIA 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 anti-hypertensive 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 |
|---|---|---|
| PolycapAssigned 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 | Polypill |
Primary outcome
Carotid Intimal Media Thickness
Time frame: Baseline and 12 months
Thickness of the intima and media layers of the carotid arteries
7 secondary outcomes
Morisky Adherence Scale Score
Time frame: 12 months
Hill-Bone Score
Time frame: 12 months
EQ-5D Quality-of-Life Score
Time frame: 12 months
Treatment Satisfaction Questionnaire for Medication Score
Time frame: 12 months
Montreal Cognitive Assessment Score
Time frame: 12 months
Modified Rankin Score
Time frame: 12 months
Hamilton Rating Scale for Depression Score
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39082406Sarfo FS, Adu-Gyamfi R, Opare-Addo PA, Agyei B, Ampofo M, Nguah SB, Ovbiagele B. Effect of a Cardiovascular Polypill on Poststroke Cognition Among Ghanaians: Secondary Analysis of a Randomized Clinical Trial. J Am Heart Assoc. 2024 Aug 6;13(15):e034346. doi: 10.1161/JAHA.124.034346. Epub 2024 Jul 31.
- Derived from this study: PubMed 37734804Sarfo FS, Voeks J, Adamu S, Agyei BA, Agbenorku M, Adu-Darko N, Oteng MA, Obese V, Gyamfi RA, Mensah NA, Tagge R, Ampofo M, Kontoh SA, Nguah SB, Ovbiagele B. A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trial. Lancet Glob Health. 2023 Oct;11(10):e1619-e1628. doi: 10.1016/S2214-109X(23)00347-9.
- Derived from this study: PubMed 29540234Sarfo FS, Sarfo-Kantanka O, Adamu S, Obese V, Voeks J, Tagge R, Sethi V, Ovbiagele B. Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial. Trials. 2018 Mar 14;19(1):181. doi: 10.1186/s13063-018-2564-0.
- Individual participant dataSharing planned: No
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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.
Jenifer Voeks, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polycap in people with Atherosclerosis and Adherence, Medication, 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 4 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: finished, as of the sponsor's last update on 20 Dec 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Carotid Intimal Media Thickness (time frame: Baseline and 12 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 NCT03329599, which also lists 3 linked publications.
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 20 Dec 2023.