Table 1 Definitions of primary and secondary outcome measures to be assessed in the SMAART trial
Variable | Brief description |
|---|---|
Primary outcome measure Carotid intima-media thickness (CIMT) | The end-of-study CIMT value will be subtracted from the baseline CIMT value and divided by the length of follow-up and the rate of change in CIMT (mm/year) between treatment arms and change in intima-media (artery wall) thickness and extent of atherosclerotic plaques in the carotid artery bifurcation measured |
Secondary outcome measures Adherence to therapy | This will be measured at months 1, 3, 6, 9 and at month-12 clinic visits using the self-reported Morisky-Green Questionnaire (MAQ) [85], pill count and Medication Possession Ratio. Patients have to meet both criteria for adherence at the in-person visits to be considered adherent |
Safety and tolerability indicators | Renal function: serum creatinine measurements to calculate eGFR using the CKD-EPI [86] formula at baseline and months 1 and 12 Liver function: elevations in liver enzymes will be assessed, if AST or ALT rises > ×5 Side effects’ profile: adverse events will be closely monitored and side effects will be documented according to the NIH/NCI Common Toxicity Criteria [87] at all scheduled and unscheduled study visitsDiscontinuation of medications: reasons and clinical indications for stopping treatment in both arms will be compared in both arms.Regimen adjustments: reasons for modifications in dosages including addition of new CVD agents, will be assessed in both treatment arms |
Health-related quality of life | The EQ-5D questionnaire [88] will be used to assess state of health of study subjects at baseline and months 6 and 12 |
Change in patient satisfaction | The Treatment Satisfaction Questionnaire for Medication [89] will be administered at baseline and months 6 and 12 |
Cognitive dysfunction indicators | The Montreal Cognitive Assessment (MOCA) scale [90] will be used to assess global cognitive dysfunction at months 0, 6 and 12 |
Functional status | Functional status after stroke will be assessed using the modified Rankin Scale with a score from 0 to 6 |
Depression | Depression will be assessed using the Beck Depression Inventory and Hamilton Rating Scale for Depression at months 0, 6 and 12 [91, 92] |
Tertiary/feasibility Cardiovascular risk factor control | 1. BP control will be defined as SBP < 140 mmHg and/or DBP < 90 mmHg or (> 135/85 mmHg in diabetes patients). Mean change in SBP at month 12 from baseline will be compared in the two treatment groups 2. Dyslipidemia: control will be defined by change in mean LDL-C < 100 mg/dl or < 70 mg/dl. Mean change in LDL-C at month 12 from baseline will be compared in the two treatment groups |
Incidence of adverse events | 1. Recurrent stroke: fatal/severely disabling stroke or non-fatal stroke; coronary artery disease: acute STEMI/NSTEMI, sudden cardiac death 2. Re-hospitalization for any CVD cause; all-cause mortality |