ATACH-II

BACKGROUND: Acute blood pressure (BP) reduction is standard of care after acute intracerebral haemorrhage (ICH). More acute BP reduction is associated with acute kidney injury (AKI). It is not known if the choice of antihypertensive medications affects the risk of AKI. METHODS: We analysed data from the ATACH-II clinical trial. AKI was defined by the Kidney Disease: Improving Global Outcomes criteria. We analysed antihypertensive medication from two sources. The first was a case report form that specified the use of labetalol, diltiazem, urapidil or other...

OBJECTIVE: The aim of this study was to better define the shape of association between the degree ("magnitude") of early (< 1 h) reduction in systolic blood pressure (SBP) and outcomes in patients with acute intracerebral hemorrhage (ICH) through pooled analysis of the second Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2) and second Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) datasets. METHODS: Association of the continuous magnitude of SBP reduction described using cubic splines and an ordinal measure of the functional outcome on the modified Rankin scale (mRS) scores at 90 days were analyzed in generalized linear mixed models...

Importance: The safety and efficacy of intensive systolic blood pressure reduction in patients with intracerebral hemorrhage who present with systolic blood pressure greater than 220 mm Hg appears to be unknown. Objective: To evaluate the differential outcomes of intensive (goal, 110-139 mm Hg) vs standard (goal, 140-179 mm Hg) systolic blood pressure reduction in patients with intracerebral hemorrhage and initial systolic blood pressure of 220 mm Hg or more vs less than 220 mm Hg...

PURPOSE: The spot sign is associated with intracerebral hemorrhage (ICH) expansion and neurological decline. However, the relationship of the spot sign to secondary intraventricular hemorrhage (IVH) has not been well established. The presence of the spot sign in secondary IVH may provide information regarding neurologic outcome in a population with known poor prognosis. METHODS: A subset analysis was performed of patients with IVH from the Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-II) study, a randomized clinical trial examining the effect of intensive blood pressure reduction on hematoma expansion...

BACKGROUND: Uncertainty persists over the effects of blood pressure lowering in acute intracerebral haemorrhage. We aimed to combine individual patient-level data from the two largest randomised controlled trials of blood pressure lowering strategies in patients with acute intracerebral haemorrhage to determine the strength of associations between key measures of systolic blood pressure control and safety and efficacy outcomes. METHODS: We did a preplanned pooled analysis of individual patient-level data acquired from the main phase of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2) and the second Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) trial...

BACKGROUND: There is persistent uncertainty over the benefits of early intensive systolic blood pressure lowering in acute intracerebral hemorrhage. In particular, over the timing, target, and intensity of systolic blood pressure control for optimum balance of potential benefits (i.e. functional recovery) and risks (e.g. cerebral ischemia). AIMS: To determine associations of early systolic blood pressure lowering parameters and outcomes in patients with a hypertensive response in acute intracerebral hemorrhage...

BACKGROUND AND PURPOSE: Although the computed tomographic angiography spot sign performs well as a biomarker for hematoma expansion (HE), computed tomographic angiography is not routinely performed in the emergency setting. We developed and validated a score to predict HE-based on noncontrast computed tomography (NCCT) findings in spontaneous acute intracerebral hemorrhage. METHODS: After developing the score in a single-center cohort of patients with intracerebral hemorrhage (n=344), we validated it in a large clinical trial population (n=954) and in a multicenter intracerebral hemorrhage cohort (n=241)...

PURPOSE: The CT angiography (CTA) spot sign is a strong predictor of hematoma expansion in intracerebral hemorrhage (ICH). However, CTA parameters vary widely across centers and may negatively impact spot sign accuracy in predicting ICH expansion. We developed a CT iodine calibration phantom that was scanned at different institutions in a large multicenter ICH clinical trial to determine the effect of image standardization on spot sign detection and performance. METHODS: A custom phantom containing known concentrations of iodine was designed and scanned using the stroke CT protocol at each institution...

OBJECTIVE: To validate various noncontrast CT (NCCT) predictors of hematoma expansion in a large international cohort of ICH patients and investigate whether intensive blood pressure (BP) treatment reduces ICH growth and improves outcome in patients with these markers. METHODS: We analyzed patients enrolled in the Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-II) randomized controlled trial. Participants were assigned to intensive (systolic BP <140 mm Hg) vs standard (systolic BP <180 mm Hg) treatment within 4...

IMPORTANCE: The computed tomographic angiography (CTA) spot sign is associated with intracerebral hemorrhage (ICH) expansion and may mark those patients most likely to benefit from intensive blood pressure (BP) reduction. OBJECTIVE: To investigate whether the spot sign is associated with ICH expansion across a wide range of centers and whether intensive BP reduction decreases hematoma expansion and improves outcome in patients with ICH and a spot sign. DESIGN, SETTING, AND PARTICIPANTS: SCORE-IT (Spot Sign Score in Restricting ICH Growth) is a preplanned prospective observational study nested in the Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-II) randomized clinical trial...

The first Intensive Blood Pressure Reduction in Acute Intracerebral Hemorrhage Trial (INTERACT1) study found that early intensive BP lowering seemed to attenuate haematoma growth when compared with a more conservative guideline based policy. Clinicians were therefore waiting with anticipation for the results of INTERACT2, in which 2839 patients with spontaneous ICH and a systolic BP between 150 and 220 mmHg were randomly assigned to receive intensive anti-hypertensive therapy with a systolic target of <140 mmHg within one hour, or a standard guideline recommended treatment of <180 mmHg...

Acute elevation in blood pressure (acute hypertensive response) is commonly observed in the early period of both ischemic and hemorrhagic stroke. The management of acute hypertensive response depends upon the underlying intracranial pathology. Management of acute hypertensive response has been the focus of many trials and studies such as the SCAST trial, CHHIPS trial, COSSACS trial, INTERACT, and ATACH trial, which are discussed here. However, there were many limitations to these trials including time of presentation, different pathophysiology of ischemic strokes versus hemorrhagic strokes, and patient related factors...

The availability of internet connectivity and mobile application software used by low-power handheld devices makes smart phones of unique value in time-sensitive clinical trials. Trial-specific applications can be downloaded by investigators from various mobile software distribution platforms or web applications delivered over HTTP. The Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH) II investigators in collaboration with MentorMate released the ATACH-II Patient Recruitment mobile application available on iPhone, Android, and Blackberry in 2011...

INTRODUCTION: The ATACH-II trial is designed to evaluate whether intensive blood pressure reduction can reduce hematoma growth and improve outcome. However, it is difficult to determine, at presentation, which patients are at highest risk of ongoing bleeding, and will receive the most clinical benefit from blood pressure therapy. It may be that improved predictive markers will lead to efficient, personalized selection of optimal therapy. We hypothesize that specific imaging findings on CT angiography (CTA) and MRI will mark those patients who receive the most benefit from intensive blood pressure reduction...

In response to growing trends and accepted U.S. Food and Drug Administration (FDA) guidance, the ATACH II trial leadership developed the independent oversight committee (IOC) as a mechanism to adjudicate the trial safety endpoints and to evaluate treatment fidelity and protocol compliance. To accomplish these tasks, the IOC reviews the first three subjects enrolled at each study center and all serious adverse events that occur across all study centers. The IOC makes recommendations to the steering committee regarding the aggregation of, or trend in, adverse events at particular sites and discusses homogeneity, or lack thereof, in the principles and intensity of the overall care...

The Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II trial is an ongoing multi-center, randomized phase III trial to determine the efficacy of early, intensive, antihypertensive treatment using intravenous (IV) nicardipine initiated within 3 h of onset of intracerebral hemorrhage (ICH). On March 11th, 2012, the National Institutes of Neurological Disorders and Stroke approved recruitment of patients with ICH within 4.5 h of symptom onset. The expansion of recruitment window was based on the recent ATACH-I study analysis that suggests reduction of hematoma expansion and death, and disability in those subjects who were treated within 4...

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...

Intracerebral hemorrhage (ICH) is a common stroke subtype in Japan. Hypertension is the leading cause. Perindopril Protection Against Recurrent Stroke Study (PROGRESS) revealed that blood pressure (BP) lowering could reduce stroke recurrence by 28% (ICH recurrence by 49%). The guideline for the management of hypertension (JSH2009) recommends BP control of ≤ 140/90 mm Hg for patients with prior stroke. BP is frequently elevated in acute ICH, although BP management strategy is controversial. The guideline from the American Stroke Association suggests if systolic BP (SBP) >180 mm Hg and there is no evidence of elevated intracranial pressure, then consider a modest reduction of BP...

The Antihypertensive Treatment for Acute Cerebral Hemorrhage (ATACH)-II Trial (ClinicalTrials.gov no. NCT01176565; (UMIN 000006526) is an international, multicenter, randomized, concurrently-controlled, parallel arm, Phase III trial to determine the therapeutic benefit of early intensive systolic blood pressure (SBP) lowering compared with standard SBP lowering for acute hypertension in patients with spontaneous intracerebral hemorrhage (ICH). The Trial is funded by the National Institutes of Health in the United States and led by Dr...

Spontaneous intracerebral hemorrhage (ICH) is intra-parenchymal bleeding that may lead to localized hematoma formation. The hematoma can enlarge over a period of time, and directly contribute to neurological deterioration and death. Several studies have shown a relationship between acute hypertensive response and poor prognosis among patients with ICH; however, it is somewhat unclear whether hematomal expansion, is a cause or a result of elevated blood pressure (BP). Current AHA guidelines state MAP should be maintained <130 mmHg and systolic blood pressure (SBP) <180 mmHg...