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Completed

NCT Number: NCT03329599

Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

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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Key information

Conditions

Atherosclerosis Adherence, Medication Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Tolerance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kwame Nkrumah University of Science & Technology

Kumasi, Ghana

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Carotid Intimal Media Thickness

    Time frame: Baseline and 12 months

    Thickness of the intima and media layers of the carotid arteries

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Northern California Institute of Research and Education

Other

Collaborators

  • Kwame Nkrumah University Teaching Hospital

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Nov 6, 2017
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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