We conducted this study according to the protocol
and statistical analysis plan, which are available
with the full text of this article at NEJM.org.
The trial was designed by three of the authors and
was overseen by the executive committee, which
had full access to the data. Data collection and entry
were performed by staff at the Tiantan Clinical
Trial and Research Center for Stroke, where the
data analysis was performed. One of the authors
had full access to an independent database for
any questions regarding the analyses. All members
of the writing committee contributed to and
approved an earlier draft of this manuscript,
which was prepared without professional editorial
assistance. The first and last authors made
the decision to submit the manuscript for publication.
All the authors assume responsibility for
the accuracy and completeness of the data and
the fidelity of this report to the study protocol.
There was no confidentiality agreement between
the study sponsor (the Ministry of Science and
Technology of the People’s Republic of China)
and the investigators. There was no commercial
support for this study.
All the participants or their legal proxies provided
written informed consent. The CHANCE
protocol was approved by the ethics committee
at each study center. Clopidogrel and the matching
placebo were purchased from Sanofi-Aventis,
which had no other role in the study.
STUDY POPULATION
Patients who met the following inclusion criteria
were eligible: age of 40 years or older; diagnosis
of an acute minor ischemic stroke or TIA; and
ability to start the study drug within 24 hours
after symptom onset, which was defined as the
point at which the patient reported no longer being
in a normal condition. Acute minor stroke
was defined by a score of 3 or less at the time of
randomization on the National Institutes of Health
Stroke Scale (NIHSS; scores range from 0 to 42,
with higher scores indicating greater deficits).
TIA was defined as focal brain ischemia with resolution
of symptoms within 24 hours after onset
plus a moderate-to-high risk of stroke recurrence
(defined as a score of ≥4 at the time of randomization
on the ABCD,2 which assesses the risk of
stroke on the basis of age, blood pressure, clinical
features, duration of TIA, and presence or absence
of diabetes; scores range from 0 to 7, with higher
scores indicating greater short-term risk).
All patients with possible clinical neurologic
events during the follow-up period underwent
computed tomography (CT) or magnetic resonance
imaging (MRI) of the head. Patients were excluded
if they had any of the following: hemorrhage;
We conducted this study according to the protocol
and statistical analysis plan, which are available
with the full text of this article at NEJM.org.
The trial was designed by three of the authors and
was overseen by the executive committee, which
had full access to the data. Data collection and entry
were performed by staff at the Tiantan Clinical
Trial and Research Center for Stroke, where the
data analysis was performed. One of the authors
had full access to an independent database for
any questions regarding the analyses. All members
of the writing committee contributed to and
approved an earlier draft of this manuscript,
which was prepared without professional editorial
assistance. The first and last authors made
the decision to submit the manuscript for publication.
All the authors assume responsibility for
the accuracy and completeness of the data and
the fidelity of this report to the study protocol.
There was no confidentiality agreement between
the study sponsor (the Ministry of Science and
Technology of the People’s Republic of China)
and the investigators. There was no commercial
support for this study.
All the participants or their legal proxies provided
written informed consent. The CHANCE
protocol was approved by the ethics committee
at each study center. Clopidogrel and the matching
placebo were purchased from Sanofi-Aventis,
which had no other role in the study.
STUDY POPULATION
Patients who met the following inclusion criteria
were eligible: age of 40 years or older; diagnosis
of an acute minor ischemic stroke or TIA; and
ability to start the study drug within 24 hours
after symptom onset, which was defined as the
point at which the patient reported no longer being
in a normal condition. Acute minor stroke
was defined by a score of 3 or less at the time of
randomization on the National Institutes of Health
Stroke Scale (NIHSS; scores range from 0 to 42,
with higher scores indicating greater deficits).
TIA was defined as focal brain ischemia with resolution
of symptoms within 24 hours after onset
plus a moderate-to-high risk of stroke recurrence
(defined as a score of ≥4 at the time of randomization
on the ABCD,2 which assesses the risk of
stroke on the basis of age, blood pressure, clinical
features, duration of TIA, and presence or absence
of diabetes; scores range from 0 to 7, with higher
scores indicating greater short-term risk).
All patients with possible clinical neurologic
events during the follow-up period underwent
computed tomography (CT) or magnetic resonance
imaging (MRI) of the head. Patients were excluded
if they had any of the following: hemorrhage;
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