Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

• Sponsor: Northern California Institute of Research and Education (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03329599
• Collaborator: Kwame Nkrumah University Teaching Hospital (Other)
• Enrollment: 148
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 37.5
• Patients Per Site Per Month: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis; Adherence, Medication; Tolerance	Drug: Polycap	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 148 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
• Actual Study Start Date: Feb 14, 2019
• Actual Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Mar 30, 2022

Arms and Interventions

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	Drug: 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
No Intervention: Usual Care Will continue to take separate, individual secondary preventive medications as prescribed

Outcome Measures

Primary Outcome Measures

1. Carotid Intimal Media Thickness [12 months]

   Carotid atherosclerosis

Secondary Outcome Measures

1. Change in Adherence to therapy [12 months]

   Proportion of patients with good adherence to polypill treatment

2. Renal Function Measures [12 months]

   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

3. Liver Function Measures [12 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kwame Nkrumah University of Science & Technology	Kumasi		Ghana

Sponsors and Collaborators

• Northern California Institute of Research and Education
• Kwame Nkrumah University Teaching Hospital

Investigators

• Principal Investigator: Jenifer Voeks, PhD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bruce Ovbiagele, Chair, Neurology, Northern California Institute of Research and Education
• ClinicalTrials.gov Identifier: NCT03329599
• Other Study ID Numbers: Pro00068785
• First Posted: Nov 6, 2017
• Last Update Posted: Feb 4, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Atherosclerosis

Study Results

No Results Posted as of Feb 4, 2022