Trial Outcomes & Findings for Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment (NCT NCT03329599)

NCT ID: NCT03329599

Last Updated: 2023-12-20

Results Overview

Thickness of the intima and media layers of the carotid arteries

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

148 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2023-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	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	Usual Care Will continue to take separate, individual secondary preventive medications as prescribed
Overall Study STARTED	74	74
Overall Study COMPLETED	59	64
Overall Study NOT COMPLETED	15	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polypill n=74 Participants 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	Usual Care n=74 Participants Will continue to take separate, individual secondary preventive medications as prescribed	Total n=148 Participants Total of all reporting groups
Age, Continuous	58.5 years STANDARD_DEVIATION 10.7 • n=5 Participants	58.1 years STANDARD_DEVIATION 13.3 • n=7 Participants	58.3 years STANDARD_DEVIATION 12.07 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	74 Participants n=5 Participants	74 Participants n=7 Participants	148 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Ghana	74 Participants n=5 Participants	74 Participants n=7 Participants	148 Participants n=5 Participants
Educational Status None	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Educational Status Primary	42 Participants n=5 Participants	28 Participants n=7 Participants	70 Participants n=5 Participants
Educational Status Secondary	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Educational Status Tertiary	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Educational Status Postgraduate	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Urban Residence	42 Participants n=5 Participants	37 Participants n=7 Participants	79 Participants n=5 Participants
Marital Status Never married	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Marital Status Married	43 Participants n=5 Participants	47 Participants n=7 Participants	90 Participants n=5 Participants
Marital Status Separated	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Marital Status Widow or widower	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Marital Status Cohabiting	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Marital Status Divorced	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Employment Status Employed	54 Participants n=5 Participants	45 Participants n=7 Participants	99 Participants n=5 Participants
Employment Status Retired	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Employment Status Unemployed	9 Participants n=5 Participants	19 Participants n=7 Participants	28 Participants n=5 Participants
Monthly Income 0-100, US $	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Monthly Income 101-250	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Monthly Income 250-500	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Monthly Income >500	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Hypertension	74 Participants n=5 Participants	74 Participants n=7 Participants	148 Participants n=5 Participants
Haemoglobin A %	6.5 percent STANDARD_DEVIATION 1.7 • n=5 Participants	7 percent STANDARD_DEVIATION 2.5 • n=7 Participants	6.75 percent STANDARD_DEVIATION 2.14 • n=5 Participants
BMI	25.4 kg/m^2 STANDARD_DEVIATION 4.3 • n=5 Participants	25.7 kg/m^2 STANDARD_DEVIATION 5.1 • n=7 Participants	25.55 kg/m^2 STANDARD_DEVIATION 4.72 • n=5 Participants
Waist-to-hip Ratio	92.2 cm STANDARD_DEVIATION 10.3 • n=5 Participants	90.6 cm STANDARD_DEVIATION 12.1 • n=7 Participants	91.4 cm STANDARD_DEVIATION 11.24 • n=5 Participants
Stroke subtype Small vessel disease	11 Participants n=5 Participants	23 Participants n=7 Participants	34 Participants n=5 Participants
Stroke subtype Large vessel disease	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Stroke subtype Undetermined	43 Participants n=5 Participants	35 Participants n=7 Participants	78 Participants n=5 Participants
NIHSS Score	2.9 score on a scale STANDARD_DEVIATION 3.4 • n=5 Participants	2.4 score on a scale STANDARD_DEVIATION 2.8 • n=7 Participants	2.65 score on a scale STANDARD_DEVIATION 2.66 • n=5 Participants
Modified Rankin Score	2.6 score on a scale STANDARD_DEVIATION 0.97 • n=5 Participants	2.74 score on a scale STANDARD_DEVIATION 0.85 • n=7 Participants	2.67 score on a scale STANDARD_DEVIATION 0.91 • n=5 Participants
Common CIMT (Carotid Intima-Media Thickness)	1.00 mm STANDARD_DEVIATION 0.17 • n=5 Participants	1.03 mm STANDARD_DEVIATION 0.16 • n=7 Participants	1.02 mm STANDARD_DEVIATION 0.17 • n=5 Participants
Morisky Adherence Scale Score	6.7 score on a scale STANDARD_DEVIATION 0.51 • n=5 Participants	6.7 score on a scale STANDARD_DEVIATION 0.37 • n=7 Participants	6.7 score on a scale STANDARD_DEVIATION 0.45 • n=5 Participants
Hill-Bone Score	50.4 score on a scale STANDARD_DEVIATION 1.81 • n=5 Participants	50.1 score on a scale STANDARD_DEVIATION 1.76 • n=7 Participants	50.25 score on a scale STANDARD_DEVIATION 1.79 • n=5 Participants
EQ-5D Quality-of-Life Score (Euro Quality of Life-5D)	83.7 score on a scale STANDARD_DEVIATION 11.6 • n=5 Participants	80.6 score on a scale STANDARD_DEVIATION 11.7 • n=7 Participants	82.15 score on a scale STANDARD_DEVIATION 11.65 • n=5 Participants
Treatment Satisfaction Questionnaire for Medication Score	53.5 score on a scale STANDARD_DEVIATION 2.8 • n=5 Participants	52.7 score on a scale STANDARD_DEVIATION 2.8 • n=7 Participants	53.1 score on a scale STANDARD_DEVIATION 2.8 • n=5 Participants
Montreal Cognitive Assessment Score	16.0 score on a scale STANDARD_DEVIATION 6.7 • n=5 Participants	16.2 score on a scale STANDARD_DEVIATION 5.78 • n=7 Participants	16.1 score on a scale STANDARD_DEVIATION 6.26 • n=5 Participants
Hamilton Rating Scale for Depression Score	5.6 score on a scale STANDARD_DEVIATION 4.36 • n=5 Participants	6.8 score on a scale STANDARD_DEVIATION 4.13 • n=7 Participants	6.2 score on a scale STANDARD_DEVIATION 4.25 • n=5 Participants
Systolic Blood Pressure, mmHg	161.3 mmHg STANDARD_DEVIATION 17.2 • n=5 Participants	160.4 mmHg STANDARD_DEVIATION 18.0 • n=7 Participants	160.85 mmHg STANDARD_DEVIATION 17.60 • n=5 Participants
Diastolic Blood Pressure, mmHg	92.0 mmHg STANDARD_DEVIATION 13.9 • n=5 Participants	92.6 mmHg STANDARD_DEVIATION 14.6 • n=7 Participants	92.3 mmHg STANDARD_DEVIATION 14.25 • n=5 Participants
Antiplatelet Therapy (aspirin or clopidogrel)	62 Participants n=5 Participants	66 Participants n=7 Participants	128 Participants n=5 Participants
Atorvastatin at 40mg or 8mg daily	55 Participants n=5 Participants	63 Participants n=7 Participants	118 Participants n=5 Participants
Angiotensin converting enzyme inhibitor	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Angiotensin receptor blocker	43 Participants n=5 Participants	43 Participants n=7 Participants	86 Participants n=5 Participants
Calcium channel blocker	62 Participants n=5 Participants	58 Participants n=7 Participants	120 Participants n=5 Participants
Diuretics	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Methyldopa	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Hydralazine	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Mineralocortcoid receptor blocker	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
β blocker	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Diabetes	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Cigarette Smoking	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Alcohol use, current	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Thickness of the intima and media layers of the carotid arteries

Outcome measures

Outcome measures
Measure	Polypill n=59 Participants 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	Usual Care n=64 Participants Will continue to take separate, individual secondary preventive medications as prescribed
Carotid Intimal Media Thickness	-0.017 mm Interval -0.067 to 0.034	-0.092 mm Interval -0.13 to -0.051

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polypill n=59 Participants 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	Usual Care n=64 Participants Will continue to take separate, individual secondary preventive medications as prescribed
Morisky Adherence Scale Score	-0.19 score on a scale Interval -0.48 to 0.1	-0.14 score on a scale Interval -0.53 to 0.24

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polypill n=59 Participants 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	Usual Care n=64 Participants Will continue to take separate, individual secondary preventive medications as prescribed
Hill-Bone Score	-0.51 score on a scale Interval -1.37 to 0.36	-1.11 score on a scale Interval -2.31 to 0.09

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polypill n=59 Participants 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	Usual Care n=64 Participants Will continue to take separate, individual secondary preventive medications as prescribed
EQ-5D Quality-of-Life Score	7.63 score on a scale Interval 5.08 to 10.18	10.23 score on a scale Interval 8.0 to 12.47

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polypill n=59 Participants 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	Usual Care n=64 Participants Will continue to take separate, individual secondary preventive medications as prescribed
Treatment Satisfaction Questionnaire for Medication Score	-10.92 score on a scale Interval -15.88 to -5.96	-6.72 score on a scale Interval -10.8 to -2.63

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polypill n=59 Participants 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	Usual Care n=64 Participants Will continue to take separate, individual secondary preventive medications as prescribed
Montreal Cognitive Assessment Score	5.17 score on a scale Interval 4.17 to 6.17	5.39 score on a scale Interval 4.13 to 6.64

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polypill n=59 Participants 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	Usual Care n=64 Participants Will continue to take separate, individual secondary preventive medications as prescribed
Modified Rankin Score	-0.92 score on a scale Interval -1.14 to -0.69	-0.89 score on a scale Interval -1.09 to -0.69

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Polypill n=59 Participants 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	Usual Care n=64 Participants Will continue to take separate, individual secondary preventive medications as prescribed
Hamilton Rating Scale for Depression Score	-3.51 score on a scale Interval -4.44 to -2.57	-4.06 score on a scale Interval -4.91 to -3.22

Adverse Events

Polypill

Serious events: 3 serious events

Other events: 5 other events

Deaths: 5 deaths

Usual Care

Serious events: 0 serious events

Other events: 7 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Polypill n=74 participants at risk 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	Usual Care n=74 participants at risk Will continue to take separate, individual secondary preventive medications as prescribed
Vascular disorders Post-stroke seizures	2.7% 2/74 • 1 year	0.00% 0/74 • 1 year
Surgical and medical procedures Hospitalization	1.4% 1/74 • 1 year	0.00% 0/74 • 1 year

Other adverse events

Other adverse events
Measure	Polypill n=74 participants at risk 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	Usual Care n=74 participants at risk Will continue to take separate, individual secondary preventive medications as prescribed
Vascular disorders Regimen Adjustments	6.8% 5/74 • 1 year	9.5% 7/74 • 1 year
Vascular disorders Treatment Discontinuation	4.1% 3/74 • 1 year	0.00% 0/74 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	4.1% 3/74 • 1 year	0.00% 0/74 • 1 year
Gastrointestinal disorders Gatrointestinal Bleeding	1.4% 1/74 • 1 year	0.00% 0/74 • 1 year

Additional Information

Bruce Ovbiagele

Northern California Institute for Research & Education

Phone: 415-750-2047

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place