Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: Rationale and design

Johnston, S. Claiborne; Easton, J. Donald; Farrant, Mary; Barsan, William G.; Battenhouse, Holly; Conwit, Robin; Dillon, Catherine; Elm, Jordan; Lindblad, Anne S.; Morgenstern, Lewis B.; Poisson, Sharon N.; Yu, Amy Y.X.

doi:10.1111/ijs.12129

Cited by 131 publications

(93 citation statements)

References 27 publications

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“…At present, a similar trial is being conducted in the United States-the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial (ClinicalTrials.gov identifier NCT00991029)-with dual or monoantiplatelet treatment initiated within 12 hours of symptom onset. 16 Results of the POINT trial and future similar trials will verify the generalizability of the effects of early initiated, short-term clopidogrel plus aspirin therapy in this patient subset. Another limitation of the current study was that we did not define symptomatic or responsible ICAS lesions, since considerable percentages of patients had a TIA as the qualifying event to be enrolled in CHANCE or had watershed or multiple infarcts, which made it difficult to define the responsible ICAS lesions, especially in TIA patients with multiple or tandem lesions.…”

Section: Patientmentioning

confidence: 86%

Dual antiplatelet therapy in stroke and ICAS

et al. 2015

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Objective: We aimed to investigate whether the efficacy and safety of clopidogrel plus aspirin vs aspirin alone were consistent between patients with and without intracranial arterial stenosis (ICAS), in the Clopidogrel in High-Risk Patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial. Methods:We assessed the interaction of the treatment effects of the 2 antiplatelet therapies among patients with and without ICAS, identified by magnetic resonance angiography (MRA) in CHANCE (ClinicalTrials.gov identifier NCT00979589). Results Conclusions:The results indicated higher rate of recurrent stroke in minor stroke or high-risk TIA patients with ICAS than in those without. However, there was no significant difference in the response to the 2 antiplatelet therapies between patients with and without ICAS in the CHANCE trial. Classification of evidence:This study provides Class II evidence that for patients with acute minor stroke or TIA with and without ICAS identified by MRA, clopidogrel plus aspirin is not significantly different than aspirin alone in preventing recurrent stroke. Previous trials indicated that clopidogrel plus aspirin might be more effective than aspirin alone in reducing microembolic signals in patients with ischemic stroke due to carotid or intracranial arterial stenoses (ICAS).1,2 However, whether such dual antiplatelet therapy could be more effective in reducing the risk of recurrence in stroke patients with ICAS is still uncertain.The risk of recurrent stroke was reduced by dual antiplatelet therapy of clopidogrel and aspirin, as compared with aspirin alone, among all the Chinese patients with acute noncardioembolic minor stroke or high-risk TIA enrolled in the Clopidogrel in High-Risk

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Section: Patientmentioning

confidence: 86%

Dual antiplatelet therapy in stroke and ICAS

et al. 2015

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“…The Platelet-Oriented Inhibition in the New TIA and Minor Ischemic Stroke (POINT) trial (ClinicalTrials.gov, Unique identifier: NCT00991029) sponsored by the National Institutes of Health, assessing the efficacy of dual-antiplatelet treatment with a higher loading dose of clopidogrel (600 mg) and a narrower time window (treatment within 12 hours after symptom onset) than were used in our study, is now enrolling patients at sites primarily in the United States. 25 Second, the characteristics of patients enrolled in the CHANCE trial were different from those of a typical TIA sample from population-based cohorts. 26,27 Females were a minority in our study (33%).…”

Section: Discussionmentioning

confidence: 99%

Clopidogrel With Aspirin in Acute Minor Stroke or Transient Ischemic Attack (CHANCE) Trial

Wang¹,

Pan²,

Wang³

et al. 2015

Circulation

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T he early risk of recurrence of stroke following index transient ischemic attack (TIA) or minor ischemic stroke is very high, even in patients treated with aspirin.1-3 The Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial was designed to assess whether the combination treatment of clopidogrel and aspirin taken soon after a TIA or minor stroke could reduce the early risk of stroke. 4 The original study termination of the CHANCE trial was 90 days from randomization, and the results showed that clopidogrel-aspirin treatment decreases the 90-day risk of stroke (hazard ratio, 0.68, 95% confidence interval [CI], 0.57-0.81; P<0.001) but does not increase the risk of hemorrhage in comparison with aspirin alone. 5 Clinical Perspective on p 46Trials of clopidogrel in the acute phase after stroke or TIA were suggested to follow up beyond the cessation of clopidogrel for the concern about rebound increase in risk of recurrence of stroke. [6][7][8] We performed an additionalBackground-The Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial showed that the combined treatment of clopidogrel and aspirin decreases the 90-day risk of stroke without increasing hemorrhage in comparison with aspirin alone, but provided insufficient data to establish whether the benefit persisted over a longer period of time beyond the trial termination. We report the 1-year follow-up outcomes of this trial. Methods and Results-The trial was a randomized, double-blind, placebo-controlled trial conducted at 114 centers in China. We randomly assigned 5170 patients within 24 hours after onset of minor stroke or high-risk transient ischemic attack to clopidogrel-aspirin therapy (loading dose of 300 mg of clopidogrel on day 1, followed by 75 mg of clopidogrel per day for 90 days, plus 75 mg of aspirin per day for the first 21 days) or to the aspirin-alone group (75 mg/d for 90 days). The primary outcome was stroke event (ischemic or hemorrhagic) during 1-year follow-up. Differences in outcomes between groups were assessed by using the Cox proportional hazards model. Stroke occurred in 275 (10.6%) patients in the clopidogrel-aspirin group, in comparison with 362 (14.0%) patients in the aspirin group (hazard ratio, 0.78; 95% confidence interval, 0.65-0.93; P=0.006). Moderate or severe hemorrhage occurred in 7 (0.3%) patients in the clopidogrel-aspirin group and in 9 (0.4%) patients in the aspirin group (P=0.44). 1-year visit for the CHANCE trial and patients in both treatment groups were followed up between October 2010 and July 2013 to establish whether the early benefit in the clopidogrel-aspirin group would persist over a longer period of time, or whether the clopidogrel-aspirin group would have a high rate of late strokes that would eliminate or even inverse the early efficacy gap between the 2 groups. We report the 1-year follow-up results of the CHANCE trial in this article. Conclusions-The Methods Study Design and SubjectsDetails on the rationale, design, an...

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“…Nonetheless, we will wait the results of the PlateletOriented Inhibition in New TIA and Minor Ischemic Stroke trial to confirm the safety of clopi-dogrel dosing in this group. 16 Nonetheless, 4 patients receiving bolus precipitated intracerebral hemorrhage postprocedurally. One died, and 3 had small right temporal and frontal bleeding, who ended up having minimal neurologic sequelae (mRS 2).…”

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confidence: 99%