Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)

NCT05963568 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 22-37310
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 500 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.

Conditions

Stroke; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Composite vascular risk factor control

  Proportion of people who have 0, 1, 2 and 3 of the following: systolic BP \<140 mm Hg, LDL-cholesterol \<100mg/dl, antiplatelet adherence by pill count \>90%) at month 12 and month 24 (sustainment of effect)

  12 and 24 months

Secondary Outcomes (5)

• Major adverse cardiovascular events (MACE)

  24 months

• Change in adherence to medical therapy

  Month 3, 6, 9, 12, 18 & 24

• Safety and tolerability

  Up to 24 months

• Health-related quality of life EuroQol-5D

  Up to 24 months

• Health-related quality of life Neuro-QoLTM

  Up to 24 months

Other Outcomes (18)

• Organizational Capacity for Change Score

  Up to 30 months

• Mean Cost of Implementation

  Up to 30 months

• Proportion who achieves systolic blood pressure <140 mmHg

  Months 12 and 24

Study Arms (2)

Intervention

EXPERIMENTAL

Patients allocated to the experimental arm will receive Two (2) (Polycap ®) taken orally once a day. A capsule of Polycap ® contains 100mg of Aspirin, 20mg of simvastatin, 12.5mg hydrochlorothiazide, 5mg of ramipril and 50mg of atenolol. Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn \& replaced with the Polypill if they are already receiving such treatments before enrollment.

Drug: Polycap

Control arm

NO INTERVENTION

Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention with drugs and doses left at the discretion of the treating physicians. Since our focus is to isolate the effect of the polypill strategy itself \& create equipoise, at study inception providers for patients in both study arms will receive a brief one-time (Skype-based) training \& a one time email synopsis on guideline recommended biomarker targets after stroke.

Interventions

Polycap DRUG

Patients allocated to the experimental arm will receive Two (2) (Polycap ®) taken orally once a day. A capsule of Polycap ® contains 100mg of Aspirin, 20mg of simvastatin, 12.5mg hydrochlorothiazide, 5mg of ramipril and 50mg of atenolol. Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn and replaced with the Polypill if they are already receiving such treatments before enrollment.

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above the age of 18 years; male or female
• Ischemic stroke 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 antihypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction
• Legally competent to sign informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern California Institute of Research and Education: lead

Study Sites (1)

Kwame Nkrumah Institute of Science & Technology

Kumasi, Ghana

Location

Related Publications (1)

• Sarfo FS, Wahab K, Matuja SS, Adebayo PB, Adoukonou T, Tagge R, Ovbiagele B. Stroke minimization through additive anti-atherosclerotic agents in routine treatment (SMAART) II: Rationale for a multi-country polypill phase 3 trial in sub-Saharan Africa. Equity Neurosci. 2026 Apr;2(1):100020. doi: 10.1016/j.neuros.2026.100020. Epub 2026 Jan 22.

  PMID: 41727852 DERIVED

MeSH Terms

Conditions

Stroke; Medication Adherence

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Bruce Ovbiagele, MD

CONTACT

415-750-2047; bruce.ovbiagele@va.gov

Raelle Tagge, MPH

CONTACT

raelle.tagge@ncire.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Staff

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: July 27, 2023
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

GH (1)