Background
Methods/design
Trial objectives
Study design and centres
Study population
Inclusion criteria | Exclusion criteria |
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Patients with acute ischaemic stroke or TIA (ABCD2 Score ≥ 3 points) Age ≥ 18 years Signed informed consent | Patients living outside the catchment area Malignancy or other severe disease with life-expectancy less than the expected duration of the trial Drug addiction or severe alcohol abuse Patients with permanent severe disability and low perspectives for successful rehabilitation (mRS [19] = 5 at discharge) |
Randomisation and follow-up
Intervention
Standard care
Stroke-CARD
Condition | Target | Intervention to achieve the targets |
---|---|---|
Hypertension | BP < 140/90 mmHg BP < 130/85 mmHg in patients with diabetes, renal impairment or small-vessel disease | Adjustment of anti-hypertensive medication Information on supportive lifestyle changes Written recommendations to and intensified management by the GP |
Dyslipidaemia | LDL-C < 100 mg/dL LDL-C < 70 mg/dL in very high-risk patients | Adjustment of statin dosage Prescription of ezetimibe additionally to high-dose statins (according to guidelines) Involvement of a lipid-clinic and prescription of PCSK9 inhibitors (according to guidelines) Individualised recommendations by a dietitian |
Diabetes | HbA1c < 7% | Re-evaluation of the therapeutic regime by a diabetes-specialist Additional management by the GP, re-instruction in correct administration of injectable pharmacological agents Individualised recommendations by a dietitian |
Smoking | Nicotine abstinence | Motivational interviewing and counselling Provision of informational material Involvement of a psychiatric specialist for behavioural or pharmacological therapy |
Physical inactivity | Physical activity of moderate to vigorous intensity with an average of 40 min at least 3 times per week | Motivational interviewing Provision of informational material |
Non-adherence to drug prescriptions | Adherence to drug prescription (proportion of days covered ≥90%) | Motivational interviewing with information on indication & therapeutic effect of current medication Simplification of drug-regimes Home support by nurses and/or relatives |
Poor “stroke-knowledge” of patients & family-members or caregivers | Information on stroke pathophysiology & individual stroke mechanism Provision of a book and standardised information material | |
Post-stroke complicationsa & poor functional outcome | Improvement of QoL | Individualised treatment & prevention of post-stroke complications Provision of further outpatient or inpatient rehabilitation Re-assessment on nursing demands, social integration & outpatient care Involvement of a social worker |
Study, Country | Y | Inclusion criteria | n | Age | M (%) | Intervention type/model | FU (Mo) | Outcome measures | Significant results |
---|---|---|---|---|---|---|---|---|---|
PRAISE, USA [42] | 2014 | Ischaemic stroke, TIA < 5 years, age > 40 y | 600 | 63 ± 11 | 40 | Education & self-management (peer-led), 6 weekly workshops | 6 | Cholesterol, BP, antithrombotics use | BP-lowering |
ICARUSS, Australia [43] | 2009 | Ischaemic stroke, haemorrhagic stroke, TIA, age > 20 y | 233 | 66 ± 13 | 54 | Education & pre-arranged visits at the GP’s at 2 weeks, 3, 6, 9, 12 Mo. Telephone assessment prior to each visit | 12 | RF-modification, disability, QoL, cognitive function, ADLs | Cholesterol-, BP-lowering, exercise, disability, QoL |
Hornnes et al., Denmark [44] | 2011 | Ischaemic stroke or TIA, all age-groups | 349 | 69 ± 12 | 45 | Pre-discharge or outpatient appointment, nurse-led home visits at 1, 4, 7, 10 Mo | 12 | BP after one year | BP-lowering |
INSPiRE-TMS, Germany [51] | 2013 | TIA, minor stroke, age > 18 y | Target = 2082 | N/A | N/A | RF-management & support program, up to 8 assessments | 24 | Stroke, ACS, cardiovascular death, RF-control, mortality, hospital admissions | ongoing |
SMART study, China [45] | 2014 | Ischaemic stroke, TIA related to atherosclerosis | 3821 | 61 ± 12 | 68 | Medication & lifestyle advice, education (computer software) | 12 | Adherence to drugs, stroke, ACS, all-cause death | better adherence to statins |
STANDFIRM, Australia [46] | 2017 | Ischaemic stroke, haemorrhagic stroke, TIA, age > 18 y | 563 | 70 | N/A | Community-based intervention, evidence-based care plan, 3 education sessions, 2 telephone assessments | 24 | Targets for cardiometabolic factors | cholesterol levels |
COMPASS, USA [52] | 2017 | Ischaemic stroke, haemorrhagic stroke, TIA, age > 18 y | Target = 6000 | N/A | N/A | holistic approach integrating medical & community resources, clinical visit after 14 days, 4 telephone assessments | 3 | Functional status, Qol, cognitive function, hospitalisations, caregiver measures | ongoing |
SUCCEED, USA [53] | 2017 | Ischaemic stroke, TIA, haemorrhagic stroke, hypertension, age > 40 y | Target = 516 | N/A | N/A | 3 clinic visits, 3 home visits, & telephone coordination by community health worker, self-coordination program | 36 | BP, RF-control, medication adherence, cost-effectivness | ongoing |
NAILED, Sweden [47] | 2015 | Ischaemic stroke, haemorrhagic stroke, TIA, all age-groups | 537 | 71 ± 11 | 57 | Nurse-led, telephone-based follow-up, medication adjustment | 12 | BP, LDL-C, RF-control | cholesterol-, BP-lowering |
Kono et al., Japan [48] | 2013 | Ischaemic stroke (mRS 0–1), non-cardio-embolic origin | 70 | 64 | 68 | Lifestyle intervention program with counselling at BL, 3, 6 Mo, exercise training (2x/week) for 24 weeks | 36 | Stroke or cardiac death, hospitalisation due to stroke recurrence, MI, AP or pAD, RF-control | vascular events, physical activity BP-lowering, salt intake. |
McAlister et al., Canada [49] | 2014 | Ischemic stroke, TIA, slight or no disability | 275 | 68 | 63 | Pharmacist-led or a nurse-led case manager intervention with 6 monthly visits | 12 | BP and lipid control, FRS and CDLEM | cholesterol-, BP-lowering, global vascular risk |
STROKE-CARD, Austria | 2017 | Ischaemic stroke (mRS 0–4), TIA (ABCD2-Score ≥ 3); age > 18 y | Target = 2170 | N/A | N/A | 3 Mo clinical visit with RF-assessment, online RF-monitoring | 12 | Major cardiovascular event, vascular death, QoL | ongoing |
Outcome
Primary outcomes (Co-primary endpoint)
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▪ Incidence of major cardiovascular events defined as nonfatal stroke (ischaemic or haemorrhagic), nonfatal myocardial infarction (including acute coronary syndrome requiring emergency vascularisation), and vascular death (i.e. sudden cardiac death and death from acute myocardial infarction, ischaemic or haemorrhagic stroke, heart failure, cardiovascular procedures, pulmonary embolism, or peripheral artery disease) within one year of the index event.
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▪ Health-related QoL assessed by the European Quality of Life-5 Dimensions (EQ-5D-3 L) overall health utility score one year after the index event.
Secondary outcomes
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▪ Recurrent ischaemic or haemorrhagic stroke and TIA (defined as transient neurological deficit < 24 h and absence of DWI positive lesions on MRI) within one year of the index-event.
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▪ All-cause mortality at 12 months.
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▪ Favorable functional outcome (mRS ≤2 and change in mRS) at one year and at three months.
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▪ Individual components of the EQ-5D-3 L questionnaire, i.e. mobility, self-care, usual activities, pain and discomfort, anxiety and depression after one year.
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▪ Achievement of predefined target levels in secondary prevention 12 months after the index event: BP < 140/90 mmHg [< 130/85 mmHg in selected patients], target HbA1c in patients with diabetes [mainly < 7.0%, less stringent targets in elderly], nicotine abstinence, LDL-C < 100 mg/dL [LDL-C < 70 mg/dL in high-risk patients] [23], physical activity with an average of 40 min at least 3 times per week, platelet inhibitor or anticoagulation according to ischaemic stroke aetiology [in case of oral anticoagulation with vitamin K antagonists: INR 2–3, time in therapeutic range (TTR) > 70%], statins except for patients with ischaemic strokes of non-atherosclerotic origin and no evidence of atherosclerosis (e.g. vessel dissection), medication adherence [proportion of days covered (PDC) ≥ 90%] [25]. The latter criterion focuses on statins, platelet inhibitors other than aspirin (which is typically purchased over the counter), antihypertensive medication, oral anti-diabetic drugs, and anticoagulation.