Trial-results highlights
The clinical evidence base for Nicardipine in the management of acute conditions, such as cerebral hemorrhage, includes data from pivotal studies. One such investigation, identified as NCT01176565 and known as ATACH-II, explored the impact of different systolic blood pressure (SBP) reduction strategies. This trial compared an intensive SBP reduction approach against a standard SBP reduction approach. The primary outcome measured in this study was "Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization." This specific endpoint, assessing functional outcomes, was evaluated at a target of 90 days post-randomization. The protocol allowed for assessments within a window of plus or minus 14 days, with data ultimately utilized up to plus or minus 30 days from the 90-day mark to capture the outcome.
Within the **Intensive SBP Reduction Arm** of the NCT01176565 study, a total of **186 participants** were enrolled to receive the more aggressive SBP management. For this arm, **33 participants** met the primary outcome of death or disability as determined by the modified Rankin Scale score at the 90-day assessment point. Correspondingly, the **Standard SBP Reduction Arm** in the same trial included **181 participants** who received the less intensive SBP management. In this group, **34 participants** experienced death or disability according to the modified Rankin Scale score at 90 days from randomization. These figures represent the direct counts of individuals who reached the defined primary endpoint within each respective treatment strategy arm.
All values are sourced from primary registry reporting; individual papers should be consulted for clinical decisions.