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| Name | Class |
|---|---|
| Kwame Nkrumah University Teaching Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Usual Care | No Intervention | Will continue to take separate, individual secondary preventive medications as prescribed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polycap | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carotid Intimal Media Thickness | Thickness of the intima and media layers of the carotid arteries | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenifer Voeks, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kwame Nkrumah University of Science & Technology | Kumasi | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39082406 | Derived | 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. | |
| 37734804 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Polypill | 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 Polycap: 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 |
| FG001 | Usual Care | Will continue to take separate, individual secondary preventive medications as prescribed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polypill | 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 Polycap: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Carotid Intimal Media Thickness | Thickness of the intima and media layers of the carotid arteries | Posted | Mean | 95% Confidence Interval | mm | Baseline and 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Polypill | 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 Polycap: 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-stroke seizures | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Regimen Adjustments | Vascular disorders | Systematic Assessment |
Study was conducted in a single tertiary medical centre, limiting its generalisability; The inter-rater agreement between the two independent CIMT readings per participants by the sonographers using a post-hoc intracluster correlation coefficient was fair; Future trials should be powered to assess treatment effects by stroke subtypes; Implementation of outcome measures must be performed to assess the barriers and facilitators associated with uptake.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce Ovbiagele | Northern California Institute for Research & Education | 415-750-2047 | bruce.ovbiagele@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2018 | Sep 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| 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. | 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. | 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. | 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. | 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. | 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 | 12 months |
| Sarfo 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. |
| 29540234 | Derived | Sarfo 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. |
| BG001 |
| Usual Care |
Will continue to take separate, individual secondary preventive medications as prescribed |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Educational Status | Count of Participants | Participants |
|
| Urban Residence | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Monthly Income | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Haemoglobin A % | Mean | Standard Deviation | percent |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Waist-to-hip Ratio | Mean | Standard Deviation | cm |
|
| Stroke subtype | Count of Participants | Participants |
|
| NIHSS Score | The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Ratings for each item are scored on a 3- to 5-point scale, with 0 as normal, and there is an allowance for untestable items. Scores range from 0 to 42, with higher scores indicating greater severity. Stroke severity may be stratified on the basis of NIHSS scores as follows: Very Severe: >25. | Mean | Standard Deviation | score on a scale |
|
| 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 score and 5 is the worst. | Mean | Standard Deviation | score on a scale |
|
| Common CIMT (Carotid Intima-Media Thickness) | Mean | Standard Deviation | mm |
|
| 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 score and 8 is the best. | Mean | Standard Deviation | score on a scale |
|
| 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 (maximum). 14 is the worst and 56 is the best. | Mean | Standard Deviation | score on a scale |
|
| EQ-5D Quality-of-Life Score (Euro Quality of Life-5D) | 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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 ≥24: Severe depression 0 is the best, 24 is the worst. | Mean | Standard Deviation | score on a scale |
|
| Systolic Blood Pressure, mmHg | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure, mmHg | Mean | Standard Deviation | mmHg |
|
| Antiplatelet Therapy (aspirin or clopidogrel) | Count of Participants | Participants |
|
| Atorvastatin at 40mg or 8mg daily | Count of Participants | Participants |
|
| Angiotensin converting enzyme inhibitor | Count of Participants | Participants |
|
| Angiotensin receptor blocker | Count of Participants | Participants |
|
| Calcium channel blocker | Count of Participants | Participants |
|
| Diuretics | Count of Participants | Participants |
|
| Methyldopa | Count of Participants | Participants |
|
| Hydralazine | Count of Participants | Participants |
|
| Mineralocortcoid receptor blocker | Count of Participants | Participants |
|
| β blocker | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Cigarette Smoking | Count of Participants | Participants |
|
| Alcohol use, current | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| 5 |
| 74 |
| 3 |
| 74 |
| 5 |
| 74 |
| EG001 | Usual Care | Will continue to take separate, individual secondary preventive medications as prescribed | 2 | 74 | 0 | 74 | 7 | 74 |
| Hospitalization | Surgical and medical procedures | Systematic Assessment |
|
| Treatment Discontinuation | Vascular disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gatrointestinal Bleeding | Gastrointestinal disorders | Systematic Assessment |
|
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| D010349 |
| Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |