Trial of Early Nifedipine Treatment in Acute myocardial infarction - TRENT

Jul 10, 2003
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Date Published:
01/01/1986
Date Updated:
07/10/2003
Original Posted Date:
07/10/2003
References

Description:

Nifedipine vs. placebo for mortality in acute MI.

Hypothesis:

To evaluate the effect of nifedipine on mortality.

Study Design

Study Design:

Patients Screened: 9,292
Patients Enrolled: 4,491
Mean Follow Up: 28 days
Mean Patient Age: 39% aged 51-60; 36% aged 61-70
Female: 17.8

Patient Populations:

Admitted to critical care unit for suspected acute myocardial infarction within 24 hours of onset of chest pain
Aged between 18 and 70

Exclusions:

Pregnancy or ability to become pregnant within following 4 weeks
Systolic blood pressure < 100 mm Hg or diastolic blood pressure < 50 immediately prior to first dose of trial medication
Heart rate > 120/min immediately prior to first dose of trial medication
Severe heart failure
Known serious renal or hepatic dysfunction
Current treatment with calcium channel blockade
Inability to attend follow-up

Primary Endpoints:

Mortality at one month

Drug/Procedures Used:

Nifedipine, 10mg four times daily, vs placebo.

Principal Findings:

Roughly 64% of patients in both treatment groups sustained an acute myocardial infarction.

The overall one month mortality rates were 6.3% in the placebo treated group and 6.7% in the nifedipine treated group. By intention-to-treat analysis there was a 7% increase in overall mortality in the nifedipine group (95% CI, +30% to -16%).

Most of the deaths occurred in patients with an in hospital diagnosis of myocardial infarction, and their one month fatality rates were 9.3% for the placebo group and 10.2% for the nifedipine group.

These differences were not statistically significant. Subgroup analysis also did not suggest any particular group of patients with suspected acute myocardial infarction who might benefit from early nifedipine treatment in the dose studied.

Interpretation:

The use of short-acting nifedipine did not improve mortality when administered to patients with suspected myocardial infarction. The results are comparable to the Norwegian Nifedipine trial, where administration of nifedipine was not associated with a change in infarct size.

References:

1. British Medical Journal Clinical Research Ed 1986;293(6556):1204-8.

Keywords: Myocardial Infarction, Chest Pain, Critical Care, Nifedipine, Calcium Channel Blockers


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