Dataset Information

A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke.

ABSTRACT:

Background

Ticagrelor is one of the most recent antiplatelet drugs to be approved to treat ischemic heart disease. Its efficacy may exceed aspirin in improving clinical outcomes in patients with acute ischemic stroke who are ineligible for rt-PA.

Objectives

We evaluated the safety regarding hemorrhagic complications (as a primary endpoint) and the efficacy (as a secondary endpoint) of a 180-mg loading dose of ticagrelor given within 9 h from the onset of the first-ever non-cardioembolic ischemic stroke.

Methods

We conducted our study on patients aged 18-75 years who presented with their first clinically manifested non-cardioembolic ischemic stroke and were recruited from the emergency department OF Kafr El-Sheik University Hospitals, Egypt. Eligible patients randomly received ticagrelor or aspirin loading and maintenance doses. Screening, randomization, and initiation of treatment all occurred within the first 9 h of stroke onset.

Results

Eighty-five patients received ticagrelor, and 84 received aspirin. Patients who received ticagrelor had a better clinical outcome in terms of NIHSS improvement at 2 days and 1 week of discharge and a favorable mRS score after 1 week of discharge and at 90-day follow-up. There was no significant difference between the two groups regarding hemorrhagic adverse effects.

Conclusion

This pilot study found that ticagrelor had a better clinical outcome than aspirin based on NIHSS and mRS in acute ischemic stroke patients who received it within 9 h from symptom onset and had a shorter hospital stay duration. Ticagrelor was non-inferior to aspirin regarding hemorrhagic complications.

Trial registration

We registered our trial on ClinicalTrials.gov, named after "ticagrelor versus aspirin in ischemic stroke," and with a clinical trial number (NCT03884530)-March 21, 2019.

SUBMITTER: Aref HM

PROVIDER: S-EPMC9842543 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke.

Aref Hany M HM El-Khawas Hala H Elbassiouny Ahmed A Shokri Hossam M HM Zeinhom Mohamed G MG Roushdy Tamer M TM

Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology 20221130 2

<h4>Background</h4>Ticagrelor is one of the most recent antiplatelet drugs to be approved to treat ischemic heart disease. Its efficacy may exceed aspirin in improving clinical outcomes in patients with acute ischemic stroke who are ineligible for rt-PA.<h4>Objectives</h4>We evaluated the safety regarding hemorrhagic complications (as a primary endpoint) and the efficacy (as a secondary endpoint) of a 180-mg loading dose of ticagrelor given within 9 h from the onset of the first-ever non-cardioe ...[more]

PMID: 36446950

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Project description:Reduction of subsequent disabling stroke is the main goal of preventive treatment in the acute setting after transient ischemic attack (TIA) or minor ischemic stroke. To evaluate the superiority of ticagrelor added to aspirin in preventing disabling stroke and to understand the factors associated with recurrent disabling stroke. The Acute Stroke or Transient Ischemic Attack Treated With Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) was a randomized clinical trial conducted between January 22, 2018, and December 13, 2019, with a 30-day follow-up, at 414 hospitals in 28 countries. The trial included 11 016 patients with a noncardioembolic, nonsevere ischemic stroke or high-risk TIA, including 10 803 with modified Rankin Scale score (mRS) recorded at 30 days. Ticagrelor (180-mg loading dose on day 1 followed by 90 mg twice daily for days 2-30) or placebo within 24 hours of symptom onset. All patients received aspirin, 300 to 325 mg on day 1 followed by 75 to 100 mg daily for days 2 to 30. Time to the occurrence of disabling stroke (progression of index event or new stroke) or death within 30 days, as measured by mRS at day 30. Disabling stroke was defined by mRS greater than 1. Among participants with 30-day mRS greater than 1, mean age was 68.1 years, 1098 were female (42.6%), and 2670 had an ischemic stroke (95.8%) as a qualifying event. Among 11 016 patients, a primary end point with mRS greater than 1 at 30 days occurred in 221 of 5511 patients (4.0%) randomized to ticagrelor and in 260 of 5478 patients (4.7%) randomized to placebo (hazard ratio [HR], 0.83; 95% CI, 0.69-0.99, P = .04). A primary end point with mRS 0 or 1 at 30 days occurred in 70 of 5511 patients (1.3%) and 87 of 5478 patients (1.6%) (HR, 0.79; 95% CI, 0.57-1.08; P = .14). The ordinal analysis of mRS in patients with recurrent stroke showed a shift of the disability burden following a recurrent ischemic stroke in favor of ticagrelor (odds ratio, 0.77; 95% CI, 0.65-0.91; P = .002). Factors associated with disability were baseline National Institutes of Health Stroke Scale score 4 to 5, ipsilateral stenosis of at least 30%, Asian race/ethnicity, older age, and higher systolic blood pressure, while treatment with ticagrelor was associated with less disability. In patients with TIA and minor ischemic stroke, ticagrelor added to aspirin was superior to aspirin alone in preventing disabling stroke or death at 30 days and reduced the total burden of disability owing to ischemic stroke recurrence. ClinicalTrials.gov Identifier: NCT03354429.

Project description:ImportancePrior trials of dual antiplatelet therapy excluded patients with moderate ischemic stroke. These patients were included in the Acute Stroke or Transient Ischaemic Attack Treated With Ticagrelor and ASA for Prevention of Stroke and Death (THALES) trial, but results have not been reported separately, raising concerns about safety and efficacy in this subgroup.ObjectiveTo evaluate the efficacy and safety of ticagrelor plus aspirin in patients with moderate ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score of 4 to 5).Design, setting, and participantsThe THALES trial was a randomized trial conducted at 414 hospitals in 28 countries in January 2018 and December 2019. This exploratory analysis compared patients with moderate stroke (baseline NIHSS score of 4 to 5) with patients with less severe stroke (NIHSS score of 0 to 3). A total of 9983 patients with stroke were included in the present analysis, after excluding 2 patients with NIHSS scores greater than 5 and 1031 patients with transient ischemic attack. Data were analyzed from March to April 2021.InterventionsTicagrelor (180-mg loading dose on day 1 followed by 90 mg twice daily on days 2 to 30) or placebo within 24 hours after symptom onset. All patients received aspirin, 300 to 325 mg, on day 1 followed by aspirin, 75 to 100 mg, daily on days 2 to 30. Patients were observed for 30 additional days.Main outcomes and measuresThe primary outcome was time to stroke or death within 30 days. The primary safety outcome was time to severe bleeding.ResultsIn total, 3312 patients presented with moderate stroke and 6671 presented with less severe stroke. Of those in the moderate stroke group, 1293 (39.0%) were female, and the mean (SD) age was 64.5 (10.8) years; of those in the less severe stroke group, 2518 (37.7%) were female, and the mean (SD) age was 64.8 (11.2) years. The observed primary outcome event rate in patients with moderate stroke was 7.6% (129 of 1671) for those in the ticagrelor group and 9.1% (150 of 1641) for those in the placebo group (hazard ratio, 0.84; 95% CI, 0.66-1.06); the primary outcome event rate in patients with less severe stroke was 4.7% (158 of 3359) for those in the ticagrelor group and 5.7% (190 of 3312) for those in the placebo group (hazard ratio, 0.82; 95% CI, 0.66-1.01) (P for interaction = .88). Severe bleeding occurred in 8 patients (0.5%) in the ticagrelor group and in 4 patients (0.2%) in the placebo group in those with moderate stroke compared with 16 patients (0.5%) and 3 patients (0.1%), respectively, with less severe stroke (P for interaction = .26).Conclusions and relevanceIn this study, patients with a moderate ischemic stroke had consistent benefit from ticagrelor plus aspirin vs aspirin alone compared with patients with less severe ischemic stroke, with no further increase in the risk of intracranial bleeding or other severe bleeding events.Trial registrationClinicalTrials.gov Identifier: NCT03354429.

Project description:ImportanceGinkgo diterpene lactone meglumine (GDLM) has attracted much attention because of its potential neuroprotective properties in ischemic stroke. The efficacy of GDLM in patients with acute ischemic stroke (AIS) needs to be verified by well-designed randomized clinical trials.ObjectiveTo assess the efficacy and safety of GDLM in patients with AIS.Design, setting, and participantsThis multicenter, randomized, double-blind, placebo-controlled, parallel-group trial involved 3448 patients who had AIS, were aged 18 to 80 years, had a clinically diagnosed AIS symptom within 48 hours of onset, had a modified Rankin Scale (mRS) score of 0 or 1 prior to onset, and had a National Institutes of Health Stroke Scale score ranging from 4 to 24. The trial took place at 100 centers in China from February 1, 2016, to May 1, 2018. The mRS is a global stroke disability scale with scores ranging from 0 (no symptoms or completely recovered) to 6 (death). The National Institutes of Health Stroke Scale is a tool used by clinicians to quantify impairment caused by stroke (range, 0-42, with higher scores indicating greater severity). Data were analyzed from January 2019 to December 2022.InterventionsPatients were randomized to receive GDLM or placebo once daily via intravenous infusion in a 1:1 ratio. The treatment was dispensed within 48 hours after symptoms and continued for 14 days. Interventions of thrombolysis and thrombectomy were not permitted during the treatment.Main outcomes and measuresThe primary outcome was the proportion of patients with an mRS of 0 or 1 on day 90 after randomization. Safety outcomes included adverse events and serious adverse events.ResultsA total of 3448 patients were randomized, with 1725 patients assigned to the GDLM group and 1723 patients assigned to the placebo group. The median (IQR) age of the patients was 63 (55-71) years, and 1232 (35.7%) were women. The primary outcome on day 90 occurred in 877 patients (50.8%) in the GDLM group, and 759 patients (44.1%) in the placebo group (risk difference, 6.79%; 95% CI, 3.46%-10.10%; odds ratio, 1.31; 95% CI, 1.15-1.50; relative risk, 1.15; 95% CI, 1.08-1.24; P < .001). Adverse events occurred relatively equally between the 2 groups (303 [17.6%] vs 298 [17.3%]; risk difference, 0.27%; 95% CI, -2.26% to 2.80%; odds ratio, 1.02; 95% CI, 0.85-1.21; relative risk, 1.02; 95% CI, 0.88-1.17; P = .83).Conclusions and relevanceAmong patients with AIS in this randomized clinical trial, GDLM improved the proportion of patients achieving favorable clinical outcomes at 90 days compared with placebo.Trial registrationClinicalTrials.gov Identifier: NCT02526225.

Dataset Information

A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke.

Background

Objectives

Methods

Results

Conclusion

Trial registration

Publications

A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke.

Similar Datasets

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