Alteplase Thrombolysis for Acute Noninterventional Therapy in Stroke Study

The alteplase thrombolysis for acute noninterventional therapy in stroke (ATLANTIS) study was double-blinded, randomized, multicentered, and placebo controlled (17). It initially began in August 1991, with a goal to test the efficacy and safety of IV administration of rtPA in patients with acute ischemic stroke within a 0- to 6-hr window. This company-sponsored trial was to run concurrently with the NINDS trial. However, in December 1993, safety concerns arose concerning the 5- to 6-hr time window. Enrollment was halted, and the trial was restarted as "Part B." In February 1996, after data from the NINDS trial was available, the protocol of the ATLANTIS study was amended to include only patients in the 3- to 5-hr window. The primary outcome measure was percentage of patients at 90 days with an excellent neurologic recovery, defined as a score of 0 or 1 on the NIHSS. The rtPA dosage was the same as in the NINDS trial (0.9 mg/kg). In Part B, 613 patients were randomized at 140 sites. The trial was halted in July 1998 due to nonefficacy of the treatment arm. By that time, 31 patients had received study drug in 3 hr or less, 547 had received study drug between 3 and 5 hr. It was reported that 32% of placebo and 34% of the rtPA group had an excellent recovery at day 90 (p=50.65). In the 547 patients in the target population, the mean time to treatment was approximately 4.5 hr.

This trial effectively ruled out the IV use of rtPA in the 3- to 5-hr window for acute ischemic stroke. The study group later published the data on the 61 patients who received study drug within 3 hr of stroke onset. The proportion of patients with a NIHSS of < 1 was significantly higher in the rtPA group (60.9%) than in the placebo group (26.3%; p = 0.01) ( 18 ).

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