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Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
Phase 2 trial testing Polycap in Atherosclerosis in 148 participants. Completed in 30 March 2022.
| Lead sponsor | Northern California Institute of Research and Education |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 148 |
| Start date | 14 February 2019 |
| Primary completion | 1 December 2021 |
| Estimated completion | 30 March 2022 |
| Sites | 1 location across Ghana |
Northern California Institute of Research and Education
Adults 18 to 100, any sex, with Atherosclerosis or Adherence, Medication. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Thickness of the intima and media layers of the carotid arteries
| Group | Value | 95% CI |
|---|---|---|
| Polypill | -0.017 | -0.067 – 0.034 |
| Usual Care | -0.092 | -0.130 – -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.
| Group | Value | 95% CI |
|---|---|---|
| Polypill | -0.19 | -0.48 – 0.10 |
| Usual Care | -0.14 | -0.53 – 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.
| Group | Value | 95% CI |
|---|---|---|
| Polypill | -0.51 | -1.37 – 0.36 |
| Usual Care | -1.11 | -2.31 – 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.
| Group | Value | 95% CI |
|---|---|---|
| Polypill | 7.63 | 5.08 – 10.18 |
| Usual Care | 10.23 | 8.00 – 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.
| Group | Value | 95% CI |
|---|---|---|
| Polypill | -10.92 | -15.88 – -5.96 |
| Usual Care | -6.72 | -10.80 – -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.
| Group | Value | 95% CI |
|---|---|---|
| Polypill | 5.17 | 4.17 – 6.17 |
| Usual Care | 5.39 | 4.13 – 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.
| Group | Value | 95% CI |
|---|---|---|
| Polypill | -0.92 | -1.14 – -0.69 |
| Usual Care | -0.89 | -1.09 – -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
| Group | Value | 95% CI |
|---|---|---|
| Polypill | -3.51 | -4.44 – -2.57 |
| Usual Care | -4.06 | -4.91 – -3.22 |
Time frame: 1 year. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Polypill | Usual Care |
|---|---|---|---|
| Post-stroke seizures | Vascular disorders | — | — |
| Hospitalization | Surgical and medical procedures | — | — |
| Reaction | System | Polypill | Usual Care |
|---|---|---|---|
| Regimen Adjustments | Vascular disorders | — | — |
| Treatment Discontinuation | Vascular disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Gatrointestinal Bleeding | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Post-stroke seizures, Hospitalization.
Data from ClinicalTrials.gov NCT03329599 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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