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

NCT ID: NCT05963568

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

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 Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn \& replaced with the Polypill if they are already receiving such treatments before enrollment.

Group Type: EXPERIMENTAL

Polycap

Intervention Type: 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 Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn and replaced with the Polypill if they are already receiving such treatments before enrollment.

Control arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Polycap

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 Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern California Institute of Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Bruce Ovbiagele

Chief of Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kwame Nkrumah Institute of Science & Technology

Kumasi, , Ghana

Countries

Ghana

Central Contacts

Bruce Ovbiagele, MD

Role: CONTACT

bruce.ovbiagele@va.gov

415-750-2047

Raelle Tagge, MPH

Role: CONTACT

raelle.tagge@ncire.org

Facility Contacts

Fred Sarfo, MD

Role: primary

stephensarfo78@gmail.com

Other Identifiers

22-37310

Identifier Type: -

Identifier Source: org_study_id