The New England Journal of Medicine JULY 19, 2018

Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA

Johnston SC, Easton JD, Farrant M, et al.

Bottom Line

In patients with acute minor ischemic stroke or high-risk transient ischemic attack, short-term dual antiplatelet therapy with clopidogrel and aspirin reduced the risk of major ischemic events at 90 days compared to aspirin alone but increased the risk of major hemorrhage.

Key Findings

1. The primary composite efficacy outcome (ischemic stroke, myocardial infarction, or ischemic vascular death) occurred in 5.0% of patients in the clopidogrel-aspirin group compared to 6.5% in the aspirin-alone group (hazard ratio 0.75; 95% CI, 0.59 to 0.95; P=0.02).
2. Major hemorrhage occurred in 0.9% of the clopidogrel-aspirin group versus 0.4% in the aspirin-alone group (hazard ratio 2.32; 95% CI, 1.10 to 4.87; P=0.02).
3. The trial was stopped early by the data monitoring committee because the primary efficacy benefit was outweighed by the increased safety risk of major bleeding.
4. Secondary analyses suggest that the net benefit of dual antiplatelet therapy is concentrated within the first 21 days after the index event.

Study Design

Design
RCT
Double-Blind
Sample
4,881
Patients
Duration
90 days
Median
Setting
Multicenter, international
Population Patients aged 18 or older with minor acute ischemic stroke (NIHSS score <=3) or high-risk transient ischemic attack (ABCD2 score >=4) presenting within 12 hours of symptom onset.
Intervention Clopidogrel (600 mg loading dose on day 1, then 75 mg/day) plus aspirin (50-325 mg/day).
Comparator Placebo plus aspirin (50-325 mg/day).
Outcome Composite of major ischemic events (ischemic stroke, myocardial infarction, or ischemic vascular death) at 90 days.

Study Limitations

The study was terminated early for safety reasons, which may have limited the precision of the final estimates.
The inclusion criteria focused on minor ischemic stroke and high-risk TIA, limiting the generalizability of these findings to more severe stroke presentations.
The increased rate of major hemorrhage, including intracranial bleeding, presents a significant clinical trade-off that necessitates careful patient selection.

Clinical Significance

The POINT trial establishes that while adding clopidogrel to aspirin reduces early ischemic recurrence after high-risk TIA or minor stroke, the concomitant increase in major bleeding risks mandates a cautious approach, often supporting a limited duration of dual therapy (e.g., 21 days) in clinical practice to optimize the benefit-risk profile.

Historical Context

The POINT trial was conducted in the wake of the CHANCE trial, which showed similar benefits for dual antiplatelet therapy in an exclusively Chinese population. POINT aimed to confirm these findings in a more global, diverse population, clarifying the trade-offs between reduced ischemic events and increased hemorrhagic risk in non-Asian cohorts.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

The POINT trial utilized a loading dose of 600 mg of clopidogrel followed by 75 mg daily. From a pharmacological and pathophysiological perspective, why is a high loading dose necessary in the setting of an acute minor ischemic stroke or TIA?

Key Response

Clopidogrel is a prodrug that requires hepatic conversion to its active metabolite to irreversibly inhibit the P2Y12 adenosine diphosphate receptor. In an acute thrombotic event, achieving rapid platelet inhibition is critical to prevent early recurrent stroke. A 600 mg loading dose achieves therapeutic levels of platelet inhibition within hours, whereas a standard 75 mg dose can take several days to reach steady-state inhibition, leaving the patient vulnerable during the highest-risk period.

Resident
Resident

A patient presents with a TIA and an ABCD2 score of 3. Does this patient meet the inclusion criteria for the POINT trial, and how does their risk of recurrence influence the decision to start dual antiplatelet therapy (DAPT)?

Key Response

No, the POINT trial specifically defined 'high-risk TIA' as an ABCD2 score of 4 or higher. Patients with lower scores (0-3) have a lower baseline risk of recurrent stroke, meaning the Absolute Risk Reduction (ARR) provided by DAPT may not outweigh the increased risk of major hemorrhage. Clinical decision-making must weigh the Number Needed to Treat (NNT) against the Number Needed to Harm (NNH), which is less favorable in low-risk TIA populations.

Fellow
Fellow

The CHANCE trial (conducted in China) and the POINT trial (international) both studied Clopidogrel-Aspirin DAPT but used different durations of therapy. How do their results collectively inform the optimal duration of DAPT for secondary prevention in minor stroke?

Key Response

CHANCE used DAPT for 21 days, while POINT used it for 90 days. A pooled analysis and the individual trial data show that the maximum benefit of stroke reduction occurs within the first 7 to 21 days. Conversely, the risk of major hemorrhage in the POINT trial continued to accumulate throughout the 90-day period. This suggests a 'sweet spot' of roughly 21 days of DAPT, after which the risks of bleeding may begin to outweigh the dwindling benefits of ischemic protection.

Attending
Attending

The POINT trial results show a significant reduction in major ischemic events but a significant increase in major hemorrhage. How should these findings be translated into a teaching point regarding the 'time-dependency' of treatment effects in vascular neurology?

Key Response

The teaching point is that the Hazard Ratio for ischemia is front-loaded, while the Hazard Ratio for bleeding is constant. Within the first week, the NNT to prevent a stroke is very low. By day 90, the cumulative risk of bleeding has risen significantly without a corresponding increase in ischemic protection. We should teach that DAPT is an 'acute phase' intervention rather than a long-term maintenance strategy for this specific indication.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The POINT trial was terminated early by the data and safety monitoring board after 84% of the planned enrollment. What are the statistical implications of early termination on the point estimates for efficacy and safety, particularly regarding the 'winner's curse'?

Key Response

Early termination for efficacy often leads to an overestimation of the treatment effect (the winner's curse) because trials are usually stopped at a random 'high point' in the data. Furthermore, early stopping limits the number of safety events observed, which can lead to wider confidence intervals for secondary safety outcomes like intracranial hemorrhage, potentially masking the full extent of the harm.

Journal Editor
Journal Editor

In the POINT trial, 'major hemorrhage' was defined using the GUSTO criteria rather than the TIMI or ISTH criteria. How might the choice of bleeding definition affect the reported safety profile and the comparability of these results to other antiplatelet trials?

Key Response

The GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) criteria are often considered more clinically relevant but less sensitive than ISTH (International Society on Thrombosis and Haemostasis) or TIMI (Thrombolysis in Myocardial Infarction). Using a more stringent definition of 'major' bleeding might result in a lower reported rate of adverse events, making the intervention appear safer than if a more sensitive biochemical or imaging-based definition had been used.

Guideline Committee
Guideline Committee

The 2019 AHA/ASA Updated Guidelines for the Early Management of Patients with Acute Ischemic Stroke incorporated POINT and CHANCE data. What specific level of evidence is assigned to DAPT in this population, and how do current recommendations address the discrepancy in treatment duration (21 vs 90 days)?

Key Response

The guidelines provide a Class I, Level of Evidence A recommendation for the use of DAPT (aspirin and clopidogrel) starting within 24 hours for minor stroke/high-risk TIA. Reflecting the safety signals in POINT, the 2019/2021 updates generally favor a shorter duration (21 days) or acknowledge that the benefit is maximal early on, recommending DAPT for 21 to 90 days but noting that the longer duration increases bleeding risk.

Clinical Landscape

Noteworthy Related Trials

2004

MATCH Trial

n = 7,599 · Lancet

Tested

Clopidogrel plus aspirin

Population

Patients with recent ischemic stroke or TIA and additional vascular risk factors

Comparator

Clopidogrel alone

Endpoint

Composite of ischemic stroke, myocardial infarction, vascular death, or rehospitalization for acute ischemia

Key result: The addition of aspirin to clopidogrel did not provide significant benefit over clopidogrel alone but increased the risk of major bleeding.
2013

CHANCE Trial

n = 5,170 · NEJM

Tested

Clopidogrel plus aspirin for 90 days

Population

Patients with high-risk TIA or minor ischemic stroke

Comparator

Aspirin alone

Endpoint

Stroke (ischemic or hemorrhagic) within 90 days

Key result: The combination of clopidogrel and aspirin significantly reduced the risk of stroke compared to aspirin alone in the Chinese population.
2020

THALES Trial

n = 11,016 · NEJM

Tested

Ticagrelor plus aspirin

Population

Patients with mild-to-moderate acute noncardioembolic ischemic stroke or TIA

Comparator

Aspirin alone

Endpoint

Composite of stroke or death within 30 days

Key result: Ticagrelor plus aspirin resulted in a significantly lower incidence of stroke or death compared to aspirin alone but increased the risk of severe bleeding.

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