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Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

Primary Purpose

Atherosclerosis, Adherence, Medication, Tolerance

Status
Completed
Phase
Phase 2
Locations
Ghana
Study Type
Interventional
Intervention
Polycap
Sponsored by
Northern California Institute of Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kwame Nkrumah University of Science & Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Polypill

Usual Care

Arm Description

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

Will continue to take separate, individual secondary preventive medications as prescribed

Outcomes

Primary Outcome Measures

Carotid Intimal Media Thickness
Carotid atherosclerosis

Secondary Outcome Measures

Change in Adherence to therapy
Proportion of patients with good adherence to polypill treatment
Renal Function Measures
Proportion of patients with good tolerance to polypill treatment based on Glomerular filtration rate and Serum creatinine as well as whether their symptoms cause them to discontinue their medication
Liver Function Measures
Proportion of patients with good tolerance to polypill treatment based on Aspartate transaminase, Alanine transaminase, Glomerular filtration rate and Serum creatinine as well as whether their symptoms cause them to discontinue their medication

Full Information

First Posted
August 28, 2017
Last Updated
September 29, 2022
Sponsor
Northern California Institute of Research and Education
Collaborators
Kwame Nkrumah University Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03329599
Brief Title
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
Official Title
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern California Institute of Research and Education
Collaborators
Kwame Nkrumah University Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Adherence, Medication, Tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
SMAART incorporates (i) a pilot randomized controlled trial and (ii) a human capital/institutional capacity building component. We propose a randomized, open label, blinded endpoint clinical trial with the intervention arm 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 compared with the 'usual care' arm who will continue to take separate, individual secondary preventive medications as prescribed their physicians to assess CIMT changes as a robust intermediary outcome measure for CVD events, as well as adherence, tolerability, and risk factor control rates. Furthermore, a cadre of emerging investigators from Ghana will benefit from the rich learning environment to be created through the implementation of the RCT and the interactions (2 years) with experts from the Medical University of South Carolina.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polypill
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Will continue to take separate, individual secondary preventive medications as prescribed
Intervention Type
Drug
Intervention Name(s)
Polycap
Intervention Description
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 Outcome Measure Information:
Title
Carotid Intimal Media Thickness
Description
Carotid atherosclerosis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Adherence to therapy
Description
Proportion of patients with good adherence to polypill treatment
Time Frame
12 months
Title
Renal Function Measures
Description
Proportion of patients with good tolerance to polypill treatment based on Glomerular filtration rate and Serum creatinine as well as whether their symptoms cause them to discontinue their medication
Time Frame
12 months
Title
Liver Function Measures
Description
Proportion of patients with good tolerance to polypill treatment based on Aspartate transaminase, Alanine transaminase, Glomerular filtration rate and Serum creatinine as well as whether their symptoms cause them to discontinue their medication
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenifer Voeks, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwame Nkrumah University of Science & Technology
City
Kumasi
Country
Ghana

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29540234
Citation
Sarfo FS, Sarfo-Kantanka O, Adamu S, Obese V, Voeks J, Tagge R, Sethi V, Ovbiagele B. Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial. Trials. 2018 Mar 14;19(1):181. doi: 10.1186/s13063-018-2564-0.
Results Reference
derived

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Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

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