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ISIS-4 TRIAL |
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| Problem | Suspected acute MI |
| Format | Double-blinded multi-center RCT |
| Treatment | Oral ISMN (MR) OR oral captopril OR IV magnesium |
| Control | Standard therapy |
| Population | 58050 |
| Inclusion criteria | Within 24 h of the onset of symptoms of suspected acute MI No clear indications for, or contraindications to, any one of the study treatments The only exception was that patients who were to be given non-study nitrate for just a few days could still be entered. (Such use of non-study nitrates was recorded at randomisation to allow separate analysis of the effects of the 1-month study nitrate regimen among patients who were not, at the time of randomisation, being given non-study nitrates.) |
| Exclusion criteria | Specified not by the protocol but by the responsible physician Suggested that caution should be taken with hypotension, cardiogenic shock, poor peripheral perfusion, or cases whether the chance of death was either very low or very high. |
| Follow-up | 5 weeks |
| Primary endpoint | 5-week mortality |
| Secondary endpoint(s) | - |
| Details | . |
| Brief summary: | Captopril shows benefit post-MI within 5 weeks, no nitrate/magnesium benefit |
| PAPER: ISIS-4: a randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58,050 patients with suspected acute myocardial infarction. | |
|---|---|
| Date | 18 Mar 1995 |
| Journal | Lancet. 1995 Mar 18;345(8951):669-85. |
| Information | Captopril (vs placebo) -Small but significant reduction in 5 week mortality, maintained for 1 year -Greatest advantage in high risk patients No survival benefit for ISMN or magnesium at 5 weeks ISMN well tolerated |