Estimated treatment effect of ticagrelor versus aspirin by investigator-assessed events compared with judgement by an independent event adjudication committee in the SOCRATES trial

2019 ◽  
Vol 14 (9) ◽  
pp. 908-914 ◽  
Author(s):  
J Donald Easton ◽  
Hans Denison ◽  
Scott R Evans ◽  
Mikael Knutsson ◽  
Pierre Amarenco ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Treatment Effect ◽  
Standard Procedure ◽  
Clinical Event ◽  
Minor Stroke ◽  
Double Blind ◽  
Hazard Ratios ◽  
Ischemic Attack ◽  
Post Hoc ◽  
Adjudication Committee

Background Adjudication of endpoints is a standard procedure in cardiovascular clinical trials. However, several studies indicate that the benefit of adjudication in estimating treatment effect may be limited. Aims This post hoc analysis of SOCRATES (NCT01994720) compared the treatment effects and investigated the agreement of clinical event assessment by site investigators and independent adjudicators. Methods SOCRATES compared ticagrelor and aspirin in 13,199 patients with acute minor stroke or high-risk transient ischemic attack. The primary endpoint was stroke, myocardial infarction, or death. Stroke was the major component of the primary endpoint and a secondary endpoint. The endpoints were adjudicated by a blinded independent committee. We compared the treatment effect on the primary endpoint and stroke alone based on the investigators' and adjudicators' assessments, and investigated the agreement rate on the stroke endpoint and major hemorrhages. Results The hazard ratios (95% confidence interval) for ticagrelor versus aspirin therapy for the primary endpoint were 0.89 (0.78–1.01) when calculated on adjudicator-assessed events and 0.88 (0.78–1.00) for investigator-assessed events. The hazard ratios (95% confidence intervals) for stroke were 0.86 (0.75–0.99) based on the adjudicators' diagnoses and 0.85 (0.75–0.97) based on the investigators' diagnoses. The overall agreement between adjudicator- and investigator-diagnosed stroke was 91%, and for major hemorrhages was 88%. Conclusions In SOCRATES, there was no clinically meaningful difference in the estimated treatment effect, on either the primary endpoint or stroke, by using investigator- or adjudicator-assessed events. Double-blind treatment outcome studies with stroke endpoints may not benefit from adjudication. Trial Registration ClinicalTrials.gov Identifier: NCT01994720.

scholarly journals Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD

2021 ◽  
pp. 135245852198892
Author(s):  
Bruce AC Cree ◽  
Jeffrey L Bennett ◽  
Ho Jin Kim ◽  
Brian G Weinshenker ◽  
Sean J Pittock ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Evaluation Method ◽  
Demographic Groups ◽  
Patient Demographics ◽  
Treatment History ◽  
Previous Therapy ◽  
Hazard Ratios ◽  
Secondary Endpoints ◽  
Post Hoc ◽  
Attack Type

Background: In the N-MOmentum trial, the risk of an adjudicated neuromyelitis optica spectrum disorder (NMOSD) attack was significantly reduced with inebilizumab compared with placebo. Objective: To demonstrate the robustness of this finding, using pre-specified sensitivity and subgroup analyses. Methods: N-MOmentum is a prospective, randomized, placebo-controlled, double-masked trial of inebilizumab, an anti-CD19 monoclonal B-cell-depleting antibody, in patients with NMOSD. Pre-planned and post hoc analyses were performed to evaluate the primary endpoint across a range of attack definitions and demographic groups, as well as key secondary endpoints. Results: In the N-MOmentum trial (ClinicalTrials.gov: NCT02200770), 174 participants received inebilizumab and 56 received placebo. Attack risk for inebilizumab versus placebo was consistently and significantly reduced, regardless of attack definition, type of attack, baseline disability, ethnicity, treatment history, or disease course (all with hazard ratios < 0.4 favoring inebilizumab, p < 0.05). Analyses of secondary endpoints showed similar trends. Conclusion: N-MOmentum demonstrated that inebilizumab provides a robust reduction in the risk of NMOSD attacks regardless of attack evaluation method, attack type, patient demographics, or previous therapy. The N-MOmentum study is registered at ClinicalTrials.gov: NCT2200770.

scholarly journals Comparison of outcome of patients with acute minor ischaemic stroke treated with intravenous t-PA, DAPT or aspirin

2020 ◽  
pp. svn-2019-000319
Author(s):  
Peng Wang ◽  
Mengyuan Zhou ◽  
Yuesong Pan ◽  
Xia Meng ◽  
Xingquan Zhao ◽  
...  
Keyword(s):  
Functional Outcome ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
National Institutes Of Health ◽  
Minor Stroke ◽  
Post Hoc Analysis ◽  
Intravenous Tissue Plasminogen Activator ◽  
Tissue Plasminogen ◽  
Ischemic Attack ◽  
Post Hoc

BackgroundWhether to treat minor stroke with intravenous tissue plasminogen activator (t-PA) treatment or antiplatelet therapy is a dilemma. Our study aimed to explore whether intravenous t-PA treatment, dual antiplatelet therapy (DAPT) and aspirin have different efficacies on outcomes in patients with minor stroke.MethodsA post hoc analysis of patients with acute minor stroke treated with intravenous t-PA within 4.5 hours from a nationwide multicentric electronic medical record and patients with acute minor stroke treated with DAPT and aspirin from the Clopidogrel with Aspirin in Acute Minor Stroke or Transient Ischemic Attack Database. Minor stroke was defined by a score of 0–3 on the National Institutes of Health Stroke Scale at randomisation. Favourable functional outcome (defined as modified Rankin Scale (mRS) score of 0–1 or 0–2 at 3 months).ResultsCompared with those treated with intravenous t-PA, no significant association with 3-month favourable functional outcome (defined as mRS score of 0–1) was found neither in patients treated with aspirin (87.8% vs 89.4%; OR, 0.83; 95% CI, 0.46 to 1.50; p=0.53) nor those treated with DAPT (87.4% vs 89.4%; OR, 0.84; 95% CI, 0.46 to 1.52; p=0.56). Similar results were observed for the favourable functional outcome defined as mRS score of 0–2 at 3 months.ConclusionsIn our study, no significant advantage of intravenous t-PA over DAPT or aspirin was found. Due to insufficient sample size, our study is probably unable to draw such a conclusion that that intravenous t-PA was superior or non-superior to DAPT.

Experience of implementing a novel random sampling BICR audit for investigator (INV)-assessed progression-free survival (PFS) in the PALOMA-3 trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1058-1058
Author(s):  
Xin Huang ◽  
Ke Zhang ◽  
Nicholas C. Turner ◽  
Cynthia Huang Bartlett ◽  
Carla Giorgetti ◽  
...  
Keyword(s):  
Random Sample ◽  
Primary Endpoint ◽  
Treatment Effect ◽  
Random Sampling ◽  
Randomized Clinical Trials ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Third Party ◽  
Double Blind

1058 Background: PFS has frequently been used as a primary endpoint for evaluating efficacy of anticancer therapies in randomized clinical trials. Given high correlation between INV and independent (BICR) assessments with respect to the relative treatment effect, a pre-planned BICR audit of INV progression assessment in a random subgroup of patients (pts) instead of a BICR review of all progression assessments can be an acceptable approach to verify the INV assessments and to evaluate the potential bias in INV PFS results. Methods: PALOMA-3 was a randomized, double blind, placebo (PCB) controlled, Ph 3 study with the primary objective of demonstrating the superiority of palbociclib (PAL) + fulvestrant (F) over PCB + F in women with HR+, HER2- metastatic breast cancer (MBC). The primary endpoint was INV assessed PFS. BICR assessment of PFS was performed with the use of a novel audit approach involving a random sample–based BICR to verify if the INV assessed PFS was accurate. A third-party core imaging laboratory performed the blinded review for a randomly selected subgroup of pts (~40%). NIH and PhRMA methods were used to evaluate the potential for bias in the INV PFS results. Results: PAL + F improved PFS in patients with HR+, HER2- MBC. The observed INV HR was 0.46 (95% CI: 0.36, 0.59; stratified 1-sided p < 0.0001) in favor of PAL + F. The median PFS was 9.5 mo (95% CI: 9.2, 11.0) in the PAL + F arm and 4.6 mo (95% CI: 3.5, 5.6) in the PCB + F arm (Lancet Oncol. 2016; 17: 425–39). The estimated HR of the complete BICR data incorporating the information from the complete INV assessed PFS and the random sample audited BICR subgroup was 0.33 with the upper bound of the 1-sided 95% CI of 0.47. The results confirmed the INV assessed treatment effect and detected no INV bias in favor of PAL + F. Conclusions: PALOMA-3 is the first registrational trial to use a BICR audit and has received positive reviews from regulatory agencies. The experience of implementing the random sampling BICR audit in PALOMA-3 demonstrates that this approach can be used for randomized, double blind oncology trials with solid tumors where INV assessed PFS is the primary endpoint and a large treatment effect is targeted. Sponsor: Pfizer. Clinical trial information: NCT01942135.

scholarly journals Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Petr Kaňovský ◽  
Elie P. Elovic ◽  
Angelika Hanschmann ◽  
Irena Pulte ◽  
Michael Althaus ◽  
...  
Keyword(s):  
Upper Limb ◽  
Treatment Effect ◽  
Time Frame ◽  
Duration Of Treatment ◽  
Open Label ◽  
Double Blind ◽  
Duration Of Effect ◽  
Limb Spasticity ◽  
Post Hoc ◽  
Injection Cycle

The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12–20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.

The Neuroform Atlas stent to assist coil embolization of intracranial aneurysms: a multicentre experience

2018 ◽  
Vol 10 (12) ◽  
pp. 1192-1196 ◽  
Author(s):  
Christian Ulfert ◽  
Mirko Pham ◽  
Michael Sonnberger ◽  
Franco Amaya ◽  
Johannes Trenkler ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Coil Embolization ◽  
Intracranial Aneurysms ◽  
Vessel Diameter ◽  
Minor Stroke ◽  
Parent Vessel ◽  
Sequential Approach ◽  
Clinical Safety ◽  
Complete Occlusion ◽  
Ischemic Attack

ObjectiveTo assess the clinical safety and efficacy of the Atlas microstent in stent-assisted coil embolization of wide-necked intracranial aneurysms.MethodsSingle-center observational study in 36 patients (24 female, 12 male, mean age 56 years) with 37 aneurysms for the endovascular treatment of wide-necked aneurysms. After giving informed consent, patients were included according to the following criteria: aneurysm dome-to-neck ratio <2 or neck diameter >4 mm, and a parent vessel diameter of ≤4.5 mm. Primary endpoint for clinical safety was absence of death, absence of major or minor stroke, and absence of transient ischemic attack. Primary endpoint for treatment efficacy was complete angiographic occlusion according to the Raymond-Roy occlusion classification (RROC) immediately after the procedure.ResultsIn 36/37 (97%) cases, the primary endpoint of safety was reached, one patient had a transitory ischemic attack which completely resolved until discharge. In 31/37 (84%) cases, complete occlusion (RROC 1) was reached, and in 6/36 (17%), a residual neck remained (RROC 2). A sequential approach (first stent, then coiling through the same catheter) was used in 21 cases; the other 16 were treated with the jailing technique. Deployment was technically successful in all cases. Follow-up at a median of 6.1 months was available for 29/37 (78%) aneurysms and showed complete occlusion in 27/29 aneurysms (93%) and a neck remnant in 2 cases (7%).ConclusionDeployment of the Neuroform Atlas microstent is a safe and effective method for the treatment of intracranial wide-necked aneurysms.

scholarly journals AbobotulinumtoxinA in the Management of Hallux Valgus in Adult Patients: Results of a Randomised And Placebo-Controlled Phase 2 Trial

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0044
Author(s):  
Robert Silva ◽  
Selene G. Parekh ◽  
Lawrence A. DiDomenico ◽  
David G. Armstrong ◽  
Babak Baravarian ◽  
...  
Keyword(s):  
Hallux Valgus ◽  
Primary Endpoint ◽  
Functional Disability ◽  
Rating Scale ◽  
Morphological Changes ◽  
Pain Reduction ◽  
Injection Pain ◽  
Double Blind ◽  
Significant Pain ◽  
Post Hoc

Category: Bunion Introduction/Purpose: Hallux valgus (HV) is a progressive foot deformity affecting nearly 25% of adults, characterized by pain and functional disability, and morphological changes in foot appearance due to progressive lateral deviation of the hallux. HV is initially managed with orthotic interventions, which are often ineffective. Corrective surgery can be efficacious, but is associated with significant pain, long recovery times and, potentially, recurrence. AbobotulinumtoxinA (aboBoNT-A, Dysport®) injections may correct the underlying muscle imbalance (resulting from hypertonia of specific forefoot muscles governing the hallux) thought to cause deformity, thereby reducing pain and disability associated with HV. Therefore, the aim of this phase II, placebo-controlled, parallel-group, multicenter study (NCT03569098) was to evaluate the effect of aboBoNT-A on pain and disability associated with HV in adults. Methods: Patients were randomized (1:1:1) to receive aboBoNT-A 300U, 500U, or placebo in a ≥12-week double-blind (DB) phase, followed by a 24-week open-label (OL) phase (OL Cycle 1, 300U [all patients]; OL Cycle 2, 300U or 500U). Total doses were divided equally into four specific foot muscles involved in hallux function. Eligible patients were aged 18–75 years with an HV angle 15–30° and numeric pain rating scale (NPRS) score of ≥4 (0, no pain; 10, worst possible pain). NPRS score was self-reported for 7 days before baseline and before each post-baseline visit. The primary endpoint was change from baseline in NPRS score (7- day average) before DB Week 8. Two post-hoc endpoints were defined as the percentage of days patients’ NPRS scores were: 1) lower than their lowest NPRS score before baseline; and 2) ≥2 points lower than mean baseline NPRS score. Adverse events (AEs) were monitored throughout the study. Results: No statistically significant differences were observed for aboBoNT-A 300U (n=63) or 500U (n=60) versus placebo (n=63) in NPRS scores at DB Week 8 (least squares mean [standard error]: -1.7 [0.3], -2.4 [0.3], versus -2.0 [0.3], respectively). Scores showed a trend towards pain reduction at Week 12 for aboBoNT-A 500U (-2.4 [0.3]) versus placebo (-1.7 [0.3]; p=0.06). Scores reduced further in OL Cycle 1. Post-hoc analyses showed that patients treated with aboBoNT-A 500U spent significantly more days with reduced pain before DB Week 8 compared with those treated with placebo: analysis 1) 63% versus 38% of days, respectively (p<0.01); analysis 2) 55% versus 37% of days, respectively (p=0.06). Results were similar at DB Week 12 (analysis 1: p<0.01; analysis 2: p=0.02, respectively). No new or unexpected AEs were reported. Conclusion: Although the primary endpoint was not met at Week 8, a trend towards significant pain reduction versus placebo was reported for patients with HV at Week 12 following aboBoNT-A 500U injection. Pain was further reduced with repeat injection. Post-hoc analyses indicate that HV patients spent a greater proportion of time with reduced pain following aboBoNT-A 500U injection compared with placebo. This may be a more clinically relevant assessment of benefit than NPRS score averaged over 7 days. Safety results were in line with the known profile of aboBoNT-A.

Abstract TMP20: Efficacy and Safety of Ticagrelor in Relation to Prior Aspirin Usage in the SOCRATES Trial

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
K.S. L Wong ◽  
Pierre Amarenco ◽  
Gregory W Albers ◽  
Hans Denison ◽  
J D Easton ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Dual Antiplatelet Therapy ◽  
Minor Stroke ◽  
Loading Dose ◽  
Vascular Risk ◽  
Efficacy And Safety ◽  
Significant Treatment ◽  
Group A ◽  
Ischemic Attack ◽  
Aspirin Group

Background: In the SOCRATES study (NCT01994720), addition of ticagrelor to patients on aspirin treatment before randomization may confer the effect of dual antiplatelet therapy as the antiplatelet effect of aspirin persists for more than a week. We aimed to explore safety and efficacy of ticagrelor in this pre-specified group of patients who had received aspirin prior to randomization. Methods: We randomized 13,199 patients with a non-cardioembolic, non-severe ischemic stroke or high-risk transient ischemic attack (TIA) to ticagrelor (180mg loading dose on day 1 followed by 90mg twice daily for days 2-90) or aspirin (300mg on day 1 followed by 100mg daily for days 2-90) within 24 hours of symptom onset. The prior aspirin group consisted of patients who had received aspirin within 7 days before randomization. The primary endpoint was the time to the occurrence of stroke, myocardial infarction, or death within 90 days. Results: The 4,232 patients with prior aspirin usage were older, had more vascular risk factors and vascular disease than the 8,967 patients with no prior aspirin usage. In the prior aspirin group, a primary endpoint occurred in 138/2,130 (6.5%) patients randomized to ticagrelor and in 177/2,102 (8.3%) patients randomized to aspirin (HR 0.76; 95% CI, 0.61-0.95, P=0.016) while for the non-aspirin group in 304/4,459 (6.9%) patients randomized to ticagrelor and in 320/4,508 (7.1%) patients randomized to aspirin (HR 0.96; 95%CI, 0.82-1.12, P=0.59). There was no significant treatment-by-prior-aspirin interaction (P=0.098). Major bleeding occurred in 0.7% of patients randomized to ticagrelor and in 0.4% randomized to aspirin (HR 1.58; 95% CI 0.68-3.65, P=0.28) in the prior aspirin group. Conclusion: In this pre-specified exploratory analysis, ticagrelor showed a numerically greater treatment effect over aspirin in patients taking prior aspirin, although the interaction for treatment by prior aspirin was not statistically significant. Further study is needed to evaluate the combination of ticagrelor and aspirin in patients with minor stroke/TIA.

Application of Age, Body Mass Index, Chronic Kidney Disease, Diabetes, and Genotyping Score for Efficacy of Clopidogrel: Secondary Analysis of the CHANCE Trial

Stroke ◽  
2021 ◽  
Author(s):  
Liye Dai ◽  
Jie Xu ◽  
Hongyi Yan ◽  
Zimo Chen ◽  
Yuesong Pan ◽  
...  
Keyword(s):  
Risk Factors ◽  
Transient Ischemic Attack ◽  
Platelet Reactivity ◽  
Aspirin Therapy ◽  
Minor Stroke ◽  
Stroke Recurrence ◽  
Gene Score ◽  
Cutoff Value ◽  
Hazard Ratios ◽  
Ischemic Attack

Background and Purpose: The age, body mass index, chronic kidney disease, diabetes, and genotyping (ABCD-GENE) score is a validated risk score integrating CYP2C19 genotypes with clinical risk factors influencing clopidogrel response that would allow the more precise identification of subjects at risk for high platelet reactivity and adverse clinical outcomes. Our objective was to further verify application of the ABCD-GENE score and investigate appropriate cutoff value in patients with minor stroke or transient ischemic attack. Methods: In this post-analysis of the CHANCE trial (Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events), the ABCD-GENE score was calculated for all patients enrolled in this study. By using the proposed cutoff of 10, patients were stratified as being at high risk for high platelet reactivity or not. We further categorized the ABCD-GENE score to 0 to 5, 6 to 24, and >24 to investigate the cutoff value of this scale in clinical application. Stroke recurrence at 3 months was considered as the primary outcome. Results: Among a total of 2923 patients with minor stroke/transient ischemic attack, there were 2273 (77.76%) with ABCD-GENE score <10 and 650 (22.24%) patients with ABCD-GENE score ≥10. Compared with the aspirin alone, hazard ratios (95% CIs) of the clopidogrel-aspirin therapy for stroke recurrence were 0.70 (0.54–0.91) and 0.76 (0.46–1.24), among patients of ABCD-GENE scores <10 and ABCD-GENE scores ≥10, respectively. Stratified analyses by ABCD-GENE score 0 to 5, 6 to 24, and >24, hazard ratios of the clopidogrel-aspirin therapy for stroke recurrence were 0.57 (95% CI, 0.38–0.85), 0.78 (0.58–1.06), and 1.20 (0.44–3.28) ( P value for trend=0.0052). Conclusions: Among Chinese minor stroke/transient ischemic attack population, the efficacy of clopidogrel-aspirin therapy was decreased in patients with higher ABCD-GENE score. Our study suggests that CYP2C19 genotypes and clinical risk factors can be integrated by ABCD-GENE score to estimate the efficacy of clopidogrel-aspirin therapy.

scholarly journals Antiplatelet Use and Ischemic Stroke Risk in Minor Stroke or Transient Ischemic Attack: A Post Hoc Analysis of the POINT Trial

Stroke ◽  
2021 ◽  
Author(s):  
Mohammad Anadani ◽  
Adam de Havenon ◽  
Nils Henninger ◽  
Lindsey Kuohn ◽  
Brian Mac Grory ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Antiplatelet Therapy ◽  
Transient Ischemic Attack ◽  
Dual Antiplatelet Therapy ◽  
Hazard Ratio ◽  
Adjusted Hazard Ratio ◽  
Minor Stroke ◽  
Ischemic Stroke Risk ◽  
Ischemic Attack ◽  
Post Hoc

Background and Purpose: Dual antiplatelet therapy has been shown to reduce the risk of recurrent stroke in patients with minor stroke or transient ischemic attack. However, whether the effect of dual antiplatelet therapy is modified by pretreatment antiplatelet status is unclear. Methods: This is a post hoc analysis of the POINT trial (Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke). Patients were divided into 2 groups based on pretreatment antiplatelet use. The primary outcome was ischemic stroke within 90 days of randomization. Results: We included 4881 patients of whom 41% belonged to the no pretreatment antiplatelet. Ischemic stroke occurred in 6% and 5% in the antiplatelet pretreatment and no antiplatelet pretreatment, respectively. Antiplatelet pretreatment was not associated with the risk of ischemic stroke (adjusted hazard ratio, 1.05 [95% CI, 0.81–137]) or risk of major hemorrhage (hazard ratio, 1.10 [95% CI, 0.55–2.21]; P =0.794). The effect of dual antiplatelet therapy on recurrent ischemic stroke risk was not different in patients who were on antiplatelet before randomization (adjusted hazard ratio, 0.69 [95% CI, 0.50–0.94]) as opposed to those who were not (adjusted hazard ratio, 0.75 [95% CI, 0.50–1.12]), P for interaction = 0.685. Conclusions: In patients with minor stroke and high-risk transient ischemic attack, dual antiplatelet therapy reduces the risk of ischemic stroke regardless of premorbid antiplatelet use.

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