ABSTRACT
BACKGROUND: Following transient ischemic attack (TIA) and minor stroke, the risk of recurrent stroke can be significantly reduced with short-duration dual antiplatelet therapy (DAPT). We wish to investigate whether 10 days of DAPT is as effective as 21 days' treatment. STUDY DESIGN: This is an open-label, randomized, parallel-group study comparing whether 10 days of DAPT treatment (ASA + clopidogrel) is non-inferior to 21 days of DAPT in patients with acute ischemic stroke (AIS) or high-risk TIA. In both groups, DAPT is started within 24 hours of symptom onset. This study is being conducted in approximately 15 study sites in the Kingdom of Saudi Arabia. The planned sample size is 1932. OUTCOMES: Non-inferiority of 10 days compared to 21 days of DAPT in the prevention of the composite endpoint of stroke and death at 90 days in AIS/TIA patients. The primary safety outcome is major intra-cranial and systemic hemorrhage. STUDY PERIOD: Enrolment started in the second quarter of 2023, and the completion of the study is expected in the fourth quarter of 2025. DISCUSSION: The trial is expected to show that 10 days of DAPT is non-inferior for the prevention of early recurrence of vascular events in patients with high-risk TIAs and minor strokes.
Subject(s)
Clopidogrel , Emergency Service, Hospital , Ischemic Attack, Transient , Platelet Aggregation Inhibitors , Stroke , Humans , Ischemic Attack, Transient/drug therapy , Platelet Aggregation Inhibitors/therapeutic use , Clopidogrel/therapeutic use , Clopidogrel/administration & dosage , Stroke/prevention & control , Stroke/epidemiology , Aspirin/therapeutic use , Aspirin/administration & dosage , Ischemic Stroke/prevention & control , Male , Female , Treatment Outcome , Aged , Middle Aged , Dual Anti-Platelet Therapy/methods , Time Factors , Saudi Arabia/epidemiology , Secondary Prevention/methodsABSTRACT
PURPOSE: This study aimed to investigate the outcomes of endovascular thrombectomy-treated patients in King Fahad Medical City, Riyadh, Saudi Arabia. METHODS: A retrospective cohort study of acute ischemic stroke patients treated with endovascular thrombectomy. Patients were included in the study between January 2015 and December 2022. Good outcomes were defined as a modified Rankin Scale (mRS) of 0-2 at 90 days. Multivariate logistic regression analysis was performed to identify the independent factors associated with good outcomes. RESULTS: During the study period, 369 patients with acute ischemic stroke (mean ± SD age, 61/- 15.1 yrs; 55.4 % male) underwent mechanical thrombectomy. Median National Institute of Health Stroke Scale (NIHSS) 15. Intravenous thrombolysis was administered to 34.5 % of the patients. Successful recanalization in the anterior circulation was achieved in 84.8 % of patients. Data from mRS performed after 90 days in the anterior circulation were available for 71.2 % of the patients. Of these, 41 % showed a good outcome, and the mortality rate was 22.4 %. The significant factors associated with good outcomes were age, NIHSS score, Alberta Stroke Program Early Computed Tomography Score (ASPECTS), and short arterial puncture to recanalization. CONCLUSION: The number of patients who underwent endovascular thrombectomy has increased over time. The treatment outcomes and mortality were comparable with those of previous endovascular thrombectomy registries despite the high prevalence of DM, lower ASPECT score, and prolonged onset-to-recanalization time.
Subject(s)
Brain Ischemia , Endovascular Procedures , Ischemic Stroke , Stroke , Humans , Male , Female , Ischemic Stroke/diagnostic imaging , Ischemic Stroke/therapy , Retrospective Studies , Saudi Arabia , Stroke/diagnostic imaging , Stroke/therapy , Thrombectomy/adverse effects , Thrombectomy/methods , Treatment Outcome , Endovascular Procedures/adverse effects , Brain Ischemia/diagnostic imaging , Brain Ischemia/therapyABSTRACT
In 2018, the Ministry of Health (MoH) in Saudi Arabia developed a clinical excellence strategy. An objective was to reduce variation in clinical practices in MoH hospitals, particularly for conditions with high mortality in Saudi Arabia, by applying best practice clinical standards and using the clinical audit process to measure clinical practice. The strategy included working with multiprofessional teams in hospitals to implement improvements needed in clinical practice. To test the feasibility of carrying out national clinical audits in MoH hospitals, audits were carried out in 16 MoH hospitals on four clinical subjects-acute myocardial infarction, major trauma, sepsis, and stroke. Clinical expert groups, including Saudi clinicians and an international clinical expert, developed clinical care standards for the four conditions from analyses of international and Saudi clinical guidelines. The audits were designed with the expert groups. Multiprofessional teams were appointed to carry out the audits in designated MoH hospitals. Data collectors in each hospital were trained to collect data. Workshops were held with the teams on the clinical care standards and how data would be collected for the audits, and later, on the findings of data collection and how to use the improvement process to implement changes to improve compliance with the standards. After 4 months, data collection was repeated to determine if compliance with the clinical care standards had improved. Data collected from each hospital for both cycles of data collection were independently reliably tested. All designated hospitals participated in the audits, collecting and submitting data for two rounds of data collection and implementing improvement plans after the first round of data collection. All hospitals made substantial improvements in clinical practices. Of a total of 84 measures used to assess compliance with a total of 52 clinical care standards for the four clinical conditions, improvements were made by hospital teams in 58 (69.1%) measures. Improvements were statistically significant for 34 (40.5%) measures. The project demonstrated that well-designed and executed audits using evidence-based clinical care standards can result in substantial improvements in clinical practices in MoH hospitals in Saudi Arabia. Keys to success were the improvement methodology built into the audit process and the requirement for hospitals to appoint multiprofessional teams to carry out the audits. The approach adds to evidence on the effectiveness of clinical audits in achieving improvements in clinical quality and can be replicated in national audit programmes.