Lancet
-
Randomized Controlled Trial Multicenter Study Clinical Trial
GISSI-3: effects of lisinopril and transdermal glyceryl trinitrate singly and together on 6-week mortality and ventricular function after acute myocardial infarction. Gruppo Italiano per lo Studio della Sopravvivenza nell'infarto Miocardico.
GISSI-3 is a multicentre randomised clinical trial to assess the efficacy of lisinopril, transdermal glyceryl trinitrate (GTN), and their combination in improving survival and ventricular function after acute myocardial infarction (AMI). Between June, 1991, and July, 1993, 19,394 patients were randomised from 200 coronary care units in Italy. Eligible patients presented within 24 h of symptom onset and had no clear indications for or against the study treatments. ⋯ The favourable effect of lisinopril alone or with GTN was clear also in the predefined high-risk populations (elderly patients and women) for the combined endpoint. These findings were obtained in a population intensively exposed to recommended treatments (thrombolysis 72%, beta-blockade 31%, and aspirin 84%); non-protocol treatment with angiotensin-converting-enzyme inhibitors and nitrates was allowed for specific clinical indications. No excess of unfavourable clinically relevant events in the treated groups was reported.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Assessment of neurological prognosis in comatose survivors of cardiac arrest. BRCT I Study Group.
When a patient resuscitated from cardiac arrest remains unconscious the clinician would like to have a reliable early method for predicting the outcome. The objective of our study was to predict cerebral outcome after cardiac arrest by clinical neurological examination. The data were drawn from an international multicentre controlled clinical trial of thiopentone. ⋯ On the third day it was possible to identify severely disabled or permanently comatose survivors without false predictions using both coma scores and several of their constituent variables. The best predictor was absence of motor response to pain. This modelling exercise now needs to be repeated on a new series of patients but the results do suggest that, after 3 days, stringent ethical criteria can be met and used in decision-making about termination of care in comatose cardiac arrest survivors.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Randomised trial of intravenous immunoglobulin as prophylaxis against infection in plateau-phase multiple myeloma. The UK Group for Immunoglobulin Replacement Therapy in Multiple Myeloma.
Patients with plateau-phase multiple myeloma have an increased risk of life-threatening bacterial infections and polyclonal humoral immune suppression. We conducted a randomised, double-blind, placebo-controlled, multicentre trial of intravenous immunoglobulin (IVIg) as prophylaxis against infection. 82 patients with stable multiple myeloma received monthly infusions of IVIg at 0.4 g/kg body weight or an equivalent volume of placebo (0.4% albumin) intravenously for 1 year. Other interventions, including chemotherapy, were not affected; no patient received prophylactic antibiotics. ⋯ IVIg can be given safely to plateau-phase myeloma patients. It protects against life-threatening infections and significantly reduces the risk of recurrent infections. The individuals who benefit most can be identified prospectively by measuring IgG antibody responses to pneumococcal immunisation.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
CLASP: a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group.
Pre-eclampsia is a common and serious complication of pregnancy that affects both mother and child. Review of previous small trials of antiplatelet therapy, particularly low-dose aspirin, suggested reductions of about three-quarters in the incidence of pre-eclampsia and some avoidance of intrauterine growth retardation (IUGR), but larger trials have not confirmed these results. In our multicentre study 9364 women were randomly assigned 60 mg aspirin daily or matching placebo. 74% were entered for prophylaxis of pre-eclampsia, 12% for prophylaxis of IUGR, 12% for treatment of pre-eclampsia, and 3% for treatment of IUGR. ⋯ Our findings do not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of pre-eclampsia or IUGR. Low-dose aspirin may be justified in women judged to be especially liable to early-onset pre-eclampsia severe enough to need very preterm delivery. In such women it seems appropriate to start low-dose aspirin prophylactically early in the second trimester.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. EAFT (European Atrial Fibrillation Trial) Study Group.
Several studies have established the value of anticoagulation for primary prevention of thromboembolic events in patients with non-rheumatic atrial fibrillation (NRAF). However, in patients with a recent transient ischaemic attack (TIA) or minor ischaemic stroke the preventive benefit of anticoagulation or aspirin remains unclear. Physicians in 108 centres from 13 countries collaborated to study this question. 1007 NRAF patients with a recent TIA or minor ischaemic stroke were randomised to open anticoagulation or double-blind treatment with either 300 mg aspirin per day or placebo (group 1, 669). ⋯ We conclude that anticoagulation is effective in reducing the risk of recurrent vascular events in NRAF patients with a recent TIA or minor ischaemic stroke. In absolute terms: 90 vascular events (mainly strokes) are prevented if 1000 patients are treated with anticoagulation for one year. Aspirin is a safe, though less effective, alternative when anticoagulation is contraindicated; it prevents 40 vascular events each year for every 1000 treated patients.