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On October 28, the New England Journal of Medicine (NEJM) published online the results of the CHANCE-2 study conducted by the team of Professor Wang Yongjun, Dean of Beijing Tiantan Hospital, Capital Medical University
.
The results show that for patients with mild ischemic stroke and transient ischemic attack (TIA) who carry the CYP2C19 inactivating allele, ticagrelor combined with aspirin is more effective than clopidogrel combined with aspirin in preventing stroke recurrence.
Compared with the latter, the stroke recurrence rate within 90 days was reduced by 23%
.
It is worth noting that about 60% of Asians carry the above-mentioned inactivation sites, so this result is of great value for the secondary prevention of stroke in Asian populations
.
The study found that in patients with mild ischemic stroke or TIA who carry the CYP2C19 inactivated allele, the risk of stroke within 90 days in the ticagrelor group was lower than that in the clopidogrel group (6.
0% and 7.
6%)
.
There was no difference in the risk of severe or moderate bleeding between the two groups (0.
3% and 0.
3%), but the total number of bleeding events in the ticagrelor group (5.
3%) exceeded that in the clopidogrel group (2.
5%)
.
The study is a randomized, double-blind, placebo-controlled trial carried out in 202 research centers in China.
It included 6412 patients who had mild ischemic stroke or TIA and carried the CYP2C19 allele, with a median age of 64.
8 years.
, Women accounted for 33.
8%
.
In the study, the patients were randomly divided into groups at a ratio of 1:1 within 24 hours after the onset of the disease.
One group received ticagrelor (180 mg on the first day, 90 mg twice a day on the second to 90 days) and chlorine Pidogrel was treated with placebo, and the other group received clopidogrel (300 mg on the 1st day, 75 mg once a day on the 2nd to 90th day) and ticagrelor placebo
.
In addition, both groups received 21 days of aspirin treatment
.
The main efficacy outcome of the study was new stroke, and the main safety outcome was severe or moderate bleeding.
Both events were evaluated within 90 days
.
The investigator said CHANCE-2-a prospective study on the application of pharmacogenetics for stroke prevention and treatment.
Professor Wang Yongjun said in an interview with the media that the team published the results of the CHANCE trial in NEJM in 2013, confirming that clopidogrel combined with aspirin treatment can be effective Reduce the risk of stroke recurrence in the Chinese population
.
Subsequent analysis results published in JAMA showed that the proportion of patients with CYP2C19 inactivated alleles in the Chinese population was 58.
8%.
This part of patients received clopidogrel combined with aspirin treatment and failed to benefit
.
In 2017, the team published in Circulation a Meta analysis of carrying CYP2C19 inactivated alleles and clopidogrel to prevent stroke recurrence.
Professor Tabassome Simon, a famous French pharmacogenetics expert, wrote a commentary and pointed out that prospective trials should be carried out to verify the results of the Meta analysis
.
At that time, there was no prospective study of stroke prevention and treatment using pharmacogenetics technology, so the importance of the CHANCE-2 trial is self-evident
.
In an analysis published in BMJ in 2019, the team and international experts jointly advocated that the efficacy and feasibility of CYP2C19 inactivated alleles for secondary stroke prevention still need to be verified by randomized controlled trials
.
In 2020, NEJM published the results of the THALES trial that the team participated in.
Professor Peter Rothwell pointed out in the concurrent review that the CHANCE-2 trial performed head-to-head on the efficacy of two dual antiplatelet strategies in patients with transient ischemic attack or mild stroke.
Comparison, the result is worth looking forward to
.
This once again proves the importance of the CHANCE-2 test
.
Do not pursue multiple data.
It is very important to carry out pre-tests.
In addition, Professor Wang Yongjun also pointed out the problems that should be paid attention to in the process of clinical trial design
.
The first is to determine which clinical data must be collected and tested
.
On the premise that the primary endpoint of the analysis is met, the less clinical data collected, the better, because the less clinical data, the easier the control of the trial development, and the higher the quality of the trial
.
Never pursue multiple data in one experiment
.
The PI that is newly conducting research often believes that the more indicators tested in the test, the better, but the quality of the test will decline due to this, and the gains outweigh the losses
.
The second is to carry out pre-tests
.
Through multiple rounds of demonstration in the early stage, the scientific problem of the test plan has been solved, but the feasibility problem needs to be answered through pre-tests
.
Pre-tests can find defects in the initial trial design, so that the trial protocol can be revised, which is very helpful to the smooth development of clinical trials
.
Typesetting: Li Hui Editor: Jia Weiwei Review: Wang Lina's power to advance the industry | The 7th Medical Scientist Summit (2022) is here! For more information, please click: Waiting for your recommendation|The 2021 Chinese Medical Book Selection has entered the final stage of solicitation! More than 630,000 people are online! Integrating multidisciplinary wisdom, the opening ceremony of the 2021 academic annual meeting of Chinese Traditional Chinese Medicine Psychosomatic Medicine·Academicians and Chinese Medicine Forum is here, "Physician Daily" submission public email: yishibao2017@163.
com [Note] Some pictures are from the Internet and WeChat Moments, if available Infringement, please contact to delete, thank you! Tel: 010-58302828-6808 Currently 1130000+ doctors have been following to join us
.
The results show that for patients with mild ischemic stroke and transient ischemic attack (TIA) who carry the CYP2C19 inactivating allele, ticagrelor combined with aspirin is more effective than clopidogrel combined with aspirin in preventing stroke recurrence.
Compared with the latter, the stroke recurrence rate within 90 days was reduced by 23%
.
It is worth noting that about 60% of Asians carry the above-mentioned inactivation sites, so this result is of great value for the secondary prevention of stroke in Asian populations
.
The study found that in patients with mild ischemic stroke or TIA who carry the CYP2C19 inactivated allele, the risk of stroke within 90 days in the ticagrelor group was lower than that in the clopidogrel group (6.
0% and 7.
6%)
.
There was no difference in the risk of severe or moderate bleeding between the two groups (0.
3% and 0.
3%), but the total number of bleeding events in the ticagrelor group (5.
3%) exceeded that in the clopidogrel group (2.
5%)
.
The study is a randomized, double-blind, placebo-controlled trial carried out in 202 research centers in China.
It included 6412 patients who had mild ischemic stroke or TIA and carried the CYP2C19 allele, with a median age of 64.
8 years.
, Women accounted for 33.
8%
.
In the study, the patients were randomly divided into groups at a ratio of 1:1 within 24 hours after the onset of the disease.
One group received ticagrelor (180 mg on the first day, 90 mg twice a day on the second to 90 days) and chlorine Pidogrel was treated with placebo, and the other group received clopidogrel (300 mg on the 1st day, 75 mg once a day on the 2nd to 90th day) and ticagrelor placebo
.
In addition, both groups received 21 days of aspirin treatment
.
The main efficacy outcome of the study was new stroke, and the main safety outcome was severe or moderate bleeding.
Both events were evaluated within 90 days
.
The investigator said CHANCE-2-a prospective study on the application of pharmacogenetics for stroke prevention and treatment.
Professor Wang Yongjun said in an interview with the media that the team published the results of the CHANCE trial in NEJM in 2013, confirming that clopidogrel combined with aspirin treatment can be effective Reduce the risk of stroke recurrence in the Chinese population
.
Subsequent analysis results published in JAMA showed that the proportion of patients with CYP2C19 inactivated alleles in the Chinese population was 58.
8%.
This part of patients received clopidogrel combined with aspirin treatment and failed to benefit
.
In 2017, the team published in Circulation a Meta analysis of carrying CYP2C19 inactivated alleles and clopidogrel to prevent stroke recurrence.
Professor Tabassome Simon, a famous French pharmacogenetics expert, wrote a commentary and pointed out that prospective trials should be carried out to verify the results of the Meta analysis
.
At that time, there was no prospective study of stroke prevention and treatment using pharmacogenetics technology, so the importance of the CHANCE-2 trial is self-evident
.
In an analysis published in BMJ in 2019, the team and international experts jointly advocated that the efficacy and feasibility of CYP2C19 inactivated alleles for secondary stroke prevention still need to be verified by randomized controlled trials
.
In 2020, NEJM published the results of the THALES trial that the team participated in.
Professor Peter Rothwell pointed out in the concurrent review that the CHANCE-2 trial performed head-to-head on the efficacy of two dual antiplatelet strategies in patients with transient ischemic attack or mild stroke.
Comparison, the result is worth looking forward to
.
This once again proves the importance of the CHANCE-2 test
.
Do not pursue multiple data.
It is very important to carry out pre-tests.
In addition, Professor Wang Yongjun also pointed out the problems that should be paid attention to in the process of clinical trial design
.
The first is to determine which clinical data must be collected and tested
.
On the premise that the primary endpoint of the analysis is met, the less clinical data collected, the better, because the less clinical data, the easier the control of the trial development, and the higher the quality of the trial
.
Never pursue multiple data in one experiment
.
The PI that is newly conducting research often believes that the more indicators tested in the test, the better, but the quality of the test will decline due to this, and the gains outweigh the losses
.
The second is to carry out pre-tests
.
Through multiple rounds of demonstration in the early stage, the scientific problem of the test plan has been solved, but the feasibility problem needs to be answered through pre-tests
.
Pre-tests can find defects in the initial trial design, so that the trial protocol can be revised, which is very helpful to the smooth development of clinical trials
.
Typesetting: Li Hui Editor: Jia Weiwei Review: Wang Lina's power to advance the industry | The 7th Medical Scientist Summit (2022) is here! For more information, please click: Waiting for your recommendation|The 2021 Chinese Medical Book Selection has entered the final stage of solicitation! More than 630,000 people are online! Integrating multidisciplinary wisdom, the opening ceremony of the 2021 academic annual meeting of Chinese Traditional Chinese Medicine Psychosomatic Medicine·Academicians and Chinese Medicine Forum is here, "Physician Daily" submission public email: yishibao2017@163.
com [Note] Some pictures are from the Internet and WeChat Moments, if available Infringement, please contact to delete, thank you! Tel: 010-58302828-6808 Currently 1130000+ doctors have been following to join us
