Trial · NCT03329599
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
NCT03329599, Phase 2, Completed, Northern California Institute of Research and Education; results first posted 2023-12-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment. Trials, record NCT03329599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03329599
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
- NCT number
- NCT03329599
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 148 participants, actual
- Lead sponsor
- Northern California Institute of Research and Education
- Conditions
- Atherosclerosis, Adherence, Medication, Tolerance
- Interventions
- Polycap
- First posted
- 2017-11-06
- Last updated
- 2023-12-20
- Results first posted
- 2023-12-20
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Carotid Intimal Media Thickness | Baseline and 12 months | Thickness of the intima and media layers of the carotid arteries |
| Secondary | Morisky Adherence Scale Score | 12 months | 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. |
| Secondary | Hill-Bone Score | 12 months | 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. |
| Secondary | EQ-5D Quality-of-Life Score | 12 months | 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. |
| Secondary | Treatment Satisfaction Questionnaire for Medication Score | 12 months | 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. |
| Secondary | Montreal Cognitive Assessment Score | 12 months | 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. |
| Secondary | Modified Rankin Score | 12 months | 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. |
| Secondary | Hamilton Rating Scale for Depression Score | 12 months | 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 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Carotid Intimal Media Thickness | Baseline and 12 months | mm | MEAN | |
| SECONDARY | Morisky Adherence Scale Score | 12 months | score on a scale | MEAN | |
| SECONDARY | Hill-Bone Score | 12 months | score on a scale | MEAN | |
| SECONDARY | EQ-5D Quality-of-Life Score | 12 months | score on a scale | MEAN | |
| SECONDARY | Treatment Satisfaction Questionnaire for Medication Score | 12 months | score on a scale | MEAN | |
| SECONDARY | Montreal Cognitive Assessment Score | 12 months | score on a scale | MEAN | |
| SECONDARY | Modified Rankin Score | 12 months | score on a scale | MEAN | |
| SECONDARY | Hamilton Rating Scale for Depression Score | 12 months | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Carotid Intimal Media Thickness | Polypill | -0.017 | 95% Confidence Interval -0.067 to 0.034 | mm | |
| Carotid Intimal Media Thickness | Usual Care | -0.092 | 95% Confidence Interval -0.130 to -0.051 | mm | |
| Morisky Adherence Scale Score | Polypill | -0.19 | 95% Confidence Interval -0.48 to 0.10 | score on a scale | |
| Morisky Adherence Scale Score | Usual Care | -0.14 | 95% Confidence Interval -0.53 to 0.24 | score on a scale | |
| Hill-Bone Score | Polypill | -0.51 | 95% Confidence Interval -1.37 to 0.36 | score on a scale | |
| Hill-Bone Score | Usual Care | -1.11 | 95% Confidence Interval -2.31 to 0.09 | score on a scale | |
| EQ-5D Quality-of-Life Score | Polypill | 7.63 | 95% Confidence Interval 5.08 to 10.18 | score on a scale | |
| EQ-5D Quality-of-Life Score | Usual Care | 10.23 | 95% Confidence Interval 8.00 to 12.47 | score on a scale | |
| Treatment Satisfaction Questionnaire for Medication Score | Polypill | -10.92 | 95% Confidence Interval -15.88 to -5.96 | score on a scale | |
| Treatment Satisfaction Questionnaire for Medication Score | Usual Care | -6.72 | 95% Confidence Interval -10.80 to -2.63 | score on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Polypill | 74 | |
| Overall Study | STARTED | Usual Care | 74 | |
| Overall Study | COMPLETED | Polypill | 59 | |
| Overall Study | COMPLETED | Usual Care | 64 | |
| Overall Study | NOT COMPLETED | Polypill | 15 | |
| Overall Study | NOT COMPLETED | Usual Care | 10 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Regimen Adjustments | Vascular disorders | Polypill | 5 | 74 | |
| other | Regimen Adjustments | Vascular disorders | Usual Care | 7 | 74 | |
| other | Treatment Discontinuation | Vascular disorders | Polypill | 3 | 74 | |
| other | Treatment Discontinuation | Vascular disorders | Usual Care | 0 | 74 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Polypill | 3 | 74 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Usual Care | 0 | 74 | |
| other | Gatrointestinal Bleeding | Gastrointestinal disorders | Polypill | 1 | 74 | |
| other | Gatrointestinal Bleeding | Gastrointestinal disorders | Usual Care | 0 | 74 | |
| serious | Post-stroke seizures | Vascular disorders | Polypill | 2 | 74 | |
| serious | Post-stroke seizures | Vascular disorders | Usual Care | 0 | 74 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Polypill | 5 | 74 |
| Total, all-cause mortality | Usual Care | 2 | 74 |
| Total, other adverse events | Polypill | 5 | 74 |
| Total, other adverse events | Usual Care | 7 | 74 |
| Total, serious adverse events | Polypill | 3 | 74 |
| Total, serious adverse events | Usual Care | 0 | 74 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Polypill vs Usual Care: deaths from any cause | Trial comparisons |
| Polypill vs Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03329599
GET https://conductscience.org/api/trials/v1/NCT03329599/registered