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Run-up to participation in ATACH II in Japan
1Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita 565-8565, Japan.
Insights
Early intensive blood pressure lowering may benefit acute intracerebral hemorrhage (ICH) patients. The Antihypertensive Treatment for Acute Cerebral Hemorrhage (ATACH) II trial in Japan investigates this for stroke patients.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Clinical Trials
Background:
- Intracerebral hemorrhage (ICH) is a significant cause of death and disability in Japan.
- Effective acute antihypertensive strategies for ICH are crucial for improving patient outcomes.
Purpose of the Study:
- To describe the extensive preparatory work and infrastructure development for the Antihypertensive Treatment for Acute Cerebral Hemorrhage (ATACH) II trial in Japan.
- To outline the background leading to the initiation of patient registration for this phase III clinical trial.
Main Methods:
- The report details a multi-step process including a preliminary study, a nationwide survey on antihypertensive treatments for acute ICH, and a multicenter study (SAMURAI-ICH).
- It also covers the revision of the Japanese drug label for intravenous nicardipine and the establishment of trial infrastructure.
Main Results:
- The preparatory phase successfully established the necessary framework for launching the ATACH II trial in Japan.
- This involved collaboration across seventeen Japanese institutions.
Conclusions:
- The comprehensive groundwork ensures the ATACH II trial can effectively evaluate early intensive systolic blood pressure lowering in acute ICH patients.
- This rigorous preparation is vital for advancing stroke treatment strategies.
Abstract:
Intracerebral hemorrhage (ICH) is a major cause of morbidity and mortality in Japan. Seventeen Japanese institutions are participating in the Antihypertensive Treatment for Acute Cerebral Hemorrhage (ATACH) II Trial (ClinicalTrials.gov no. NCT01176565; UMIN 000006526). This phase III trial is designed to determine the therapeutic benefit of early intensive systolic blood pressure (BP) lowering for acute hypertension in ICH patients. This report explains the long run-up to reach the start of patient registration in ATACH II in Japan, including our preliminary study, a nationwide survey on antihypertensive treatment for acute ICH patients, a multicenter study for hyperacute BP lowering (the SAMURAI-ICH study), revision of the official Japanese label for intravenous nicardipine, and construction of the infrastructure for the trial.
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