- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03329599
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Kumasi, Ghana
- Kwame Nkrumah University of Science & Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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
|
No Intervention: Usual Care
Will continue to take separate, individual secondary preventive medications as prescribed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Carotid Intimal Media Thickness
Time Frame: Baseline and 12 months
|
Thickness of the intima and media layers of the carotid arteries
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morisky Adherence Scale Score
Time Frame: 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. |
12 months
|
Hill-Bone Score
Time Frame: 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. |
12 months
|
EQ-5D Quality-of-Life Score
Time Frame: 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. |
12 months
|
Treatment Satisfaction Questionnaire for Medication Score
Time Frame: 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. |
12 months
|
Montreal Cognitive Assessment Score
Time Frame: 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. |
12 months
|
Modified Rankin Score
Time Frame: 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.
|
12 months
|
Hamilton Rating Scale for Depression Score
Time Frame: 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 |
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jenifer Voeks, PhD, Medical University of South Carolina
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00068785
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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