Clinical trial NCT05963568: Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
Official title: Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Stroke
Medication Adherence
Lead sponsor: Northern California Institute of Research and Education
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Composite vascular risk factor control
timeFrame: 12 and 24 months
Secondary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 24 months
measure: Change in adherence to medical therapy
timeFrame: Month 3, 6, 9, 12, 18 & 24
measure: Safety and tolerability
timeFrame: Up to 24 months
measure: Health-related quality of life EuroQol-5D
timeFrame: Up to 24 months
measure: Health-related quality of life Neuro-QoLTM
timeFrame: Up to 24 months
Other outcomes:
measure: Organizational Capacity for Change Score
timeFrame: Up to 30 months
measure: Mean Cost of Implementation
timeFrame: Up to 30 months
measure: Proportion who achieves systolic blood pressure <140 mmHg
timeFrame: Months 12 and 24
measure: Proportion who achieves blood pressure <140/90 mmHg
timeFrame: Months 12 and 24
measure: Proportion who achieves blood pressure < 130 / 80 mmHg
timeFrame: Months 12 and 24
measure: Proportion who achieves LDL-cholesterol <100 mg/dl
timeFrame: Months 12 and 24
measure: Proportion who achieves LDL-cholesterol <70 mg/dl
timeFrame: Months 12 and 24
measure: Proportion who achieves antiplatelet adherence of at least >=80%
timeFrame: Months 12 and 24
measure: Proportion who achieves antiplatelet adherence of at least >= 90%
timeFrame: Months 12 and 24
measure: Comparison of absolute and mean changes from baseline for blood pressure
timeFrame: Up to 24 months
measure: Comparison of absolute and mean changes from baseline for lipids
timeFrame: Up to 24 months
measure: Proportion with recurrent strokes (fatal or non-fatal)
timeFrame: Up to 24 months
measure: Proportion with coronary artery disease
timeFrame: Up to 24 months
measure: Proportion with heart failure
timeFrame: Up to 24 months
measure: Proportion with cardiovascular deaths
timeFrame: Up to 24 months
measure: Proportion with all-cause mortality
timeFrame: Up to 24 months
measure: Proportion with vascular cognitive impairment
timeFrame: Months 12 and 24
measure: Proportion with treatment-limiting adverse drug reactions or side effects
timeFrame: Up to 24 months
Locations:
city: Kumasi
country: Ghana
facility: Kwame Nkrumah Institute of Science & Technology
Study officials:
References: