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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05963568
• Other study ID #: 22-37310
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: January 2029

Study information

• Verified date: March 2024
• Source: Northern California Institute of Research and Education
• Contact: Bruce Ovbiagele, MD
• Phone: 415-750-2047
• Email: bruce.ovbiagele[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 680
• Est. completion date: January 2029
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Medication Adherence
• Stroke

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Ghana	Kwame Nkrumah Institute of Science & Technology	Kumasi

Sponsors (1)

Lead Sponsor	Collaborator
Northern California Institute of Research and Education

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Organizational Capacity for Change Score	Adoption i.e. Organizational Capacity for Change (OCC Scale Score comparison) with stratification by level of healthcare delivery. The measure is a 32-item multidimensional scale that evaluates an organization's capacity to upgrade or revise existing organizational competencies, while cultivating new competencies that enable the organization to survive and prosper. It comprises different aspects of leadership, employee behavior, and an organizational infrastructure supporting organizational change. Items are rated on a 5-point Likert scale. OCC has a Cronbach a of 0.87.	Up to 30 months
Other	Mean Cost of Implementation	Implementation Cost (mean monthly health expenses compared to standard of care)	Up to 30 months
Other	Proportion who achieves systolic blood pressure <140 mmHg		Months 12 and 24
Other	Proportion who achieves blood pressure <140/90 mmHg		Months 12 and 24
Other	Proportion who achieves blood pressure < 130 / 80 mmHg		Months 12 and 24
Other	Proportion who achieves LDL-cholesterol <100 mg/dl		Months 12 and 24
Other	Proportion who achieves LDL-cholesterol <70 mg/dl		Months 12 and 24
Other	Proportion who achieves antiplatelet adherence of at least >=80%		Months 12 and 24
Other	Proportion who achieves antiplatelet adherence of at least >= 90%		Months 12 and 24
Other	Comparison of absolute and mean changes from baseline for blood pressure	systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, measures of visit-to-visit variability in blood pressure	Up to 24 months
Other	Comparison of absolute and mean changes from baseline for lipids	Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglyceride	Up to 24 months
Other	Proportion with recurrent strokes (fatal or non-fatal)		Up to 24 months
Other	Proportion with coronary artery disease		Up to 24 months
Other	Proportion with heart failure		Up to 24 months
Other	Proportion with cardiovascular deaths		Up to 24 months
Other	Proportion with all-cause mortality		Up to 24 months
Other	Proportion with vascular cognitive impairment		Months 12 and 24
Other	Proportion with treatment-limiting adverse drug reactions or side effects		Up to 24 months
Primary	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	Major adverse cardiovascular events (MACE)	MACE to be assessed include recurrent stroke: fatal/severely disabling stroke or non-fatal stroke; coronary artery disease: acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudication committee by reviewing available clinical notes supported by investigations for example CT scans, EKGs, troponin tests, death certificates or verbal autopsy if death occurs outside hospital.	24 months
Secondary	Change in adherence to medical therapy		Month 3, 6, 9, 12, 18 & 24
Secondary	Safety and tolerability	Side effects, adverse events, treatment withdrawal	Up to 24 months
Secondary	Health-related quality of life EuroQol-5D	EuroQol-5D questionnaire (0-100 with 100 being the best)	Up to 24 months
Secondary	Health-related quality of life Neuro-QoLTM	NINDS Neuro-QoLTM (Quality of Life in Neurological Disorders) questionnaires (8-40 with 40 being the best)	Up to 24 months