Review of 12 major intravenous thrombolysis randomized trials
| Study | Agent | Time (h) | IV treatment (n) | Placebo treatment (n) | Primary outcome | Result |
|---|---|---|---|---|---|---|
| NINDS, 1995 (Part 2)11 | tPA | 0–3 | 168 | 165 | Favorable outcome*† | Positive (OR 1.7, 95% CI 1.2 to 2.6) |
| ECASS, 199512 | tPA | 0–6 | 313 | 307 | Improvement in Barthel Index by 15 at 90 days | No benefit (p=0.99) |
| MAST-1, 199516 | Streptokinase | 0–6 | 157 streptokinase alone, 156 streptokinase+ASA | 153 ASA alone, 156 placebo | 6 month case fatality or disability | No benefit (OR 0.9, 95% CI 0.7 to 1.3) |
| MAST-E, 199617 | Streptokinase | 0–6 | 156 | 154 | mRS ≥3 at 6 months | No benefit (p=0.60) |
| ASK Trial, 199618 | Streptokinase | 0–4 | 174 (41<3 h, 133>3 h) | 166 (29<3 h, 137>3 h) | Alive with Barthel score ≥60 | No benefit (OR 1.08, 95% CI 0.74 to 1.86) |
| ECASS II, 199813 | tPA | 0–6 | 409 | 391 | mRS 0 or 1 at 90 days | No benefit (0.28) |
| ATLANTIS, 199914 | tPA | 3–5 | 272 | 275 | NIHSS 0 or 1 at 90 days | No benefit (p=0.65) |
| A0276g, 200019 | tPA | 0–6 | 71 | 71 | >3 NIHSS improvement or complete recovery at 30 days | No benefit (p=0.05, in favor of placebo) |
| EPITHET, 200820 | tPA | 3–6 | 52 | 49 | Infarct growth† | No benefit (p=0.24) |
| ECASS III, 200815 | tPA | 3–4.5 | 418 | 403 | mRS of 0 or 1 at 90 days | Positive (OR 1.34, p=0.04) |
| DIAS-221, 2009 | Desmoteplase | 3–9 | 57 low dose, 66 high dose | 63 | Clinical response rate* | No benefit (p=0.47) |
| IST-3, 201222 | tPA | 0–6 | 1515 | 1520 | Oxford handicap score of 0–2 at 6 months | No benefit (p=0.18) |
*Composite of improvement in NIHSS of 8 points or more or an NIHSS score of 1 point or less, an mRS of 0–2, and a Barthel Index of 75–100.
†Between admission diffusion weighted imaging and day 90 T2 lesion.
ASA, acetylsalicylic acid; IV, intravenous; mRS, modified Rankin score; NIHSS, National Institutes of Health Stroke Scale; tPA, tissue plasminogen activator.