Randomized controlled trial of oral captopril, of oral isosorbide mononitrate and of intravenous magnesium sulphate started early in acute myocardial infarction: safety and haemodynamic effects. ISIS-4 (Fourth International Study of Infarct Survival) Pilot Study Investigators.

What Was Tested

This randomized controlled trial looks at Captopril.

The purpose of this randomized controlled study was to assess the haemodynamic effects, safety and tolerability in acute myocardial infarction (AMI) of one month of oral captopril, one month of oral isosorbide mononitrate and 24 h of intravenous magnesium.

Why It Was Studied

It was carried out in four United Kingdom and six Polish hospitals in consecutive phases: oral captopril vs oral mononitrate vs placebo were compared among 400 patients in a 'three-way' study; and then oral captopril vs placebo and oral mononitrate vs placebo were compared among 474 patients in '2 x 2' and '2 x 2 x 2' factorial studies (with 208 patients in the latter study also randomized between intravenous magnesium and open control).

Who Took Part

The abstract describes 400 patients taking part.

The age groups tagged for this paper are middle-aged adults, both men and women.

How the Study Was Run

The researchers set it up as a randomized, placebo-controlled and pilot study.

The patients were allocated by chance, so the Captopril group and the comparison group should start out alike.

Some patients received a placebo instead of Captopril, giving a reference point.

It is described as a pilot, a small early test of whether a larger Captopril study would be practical.

What Was Measured

Topics PubMed links to this paper include Captopril, Hemodynamics, Isosorbide Dinitrate, Magnesium Sulfate, Myocardial Infarction, Patient Compliance and Pilot Projects.

What This Means in Plain Language

The paper is a randomized, placebo-controlled and pilot study of Captopril in 400 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 1994 (European heart journal), a journal based in England.

More context: all human trials.