Ruda 1988

Methods	In this randomized controlled trial 60 patients diagnosed with acute myocardial infarction at the time of admission (clinical signs in combination with ECG changes typical for myocardial infarction) received CrP (Neoton) or placebo as a 2 gram bolus injection, followed by a 2‐hour infusion at the rate of 4 gram / hour. AMI diagnosis was subsequently verified by ECG, total CK, and scintigraphic scans. 24‐hour Holter monitoring was begun immediately after patients were enrolled in the study and modified ECG leads V1 and V5 were monitored. There was no follow‐up thereafter.
Participants	60 patients, mean age 56 year with AMI admitted within 6 hours of the onset of chest pain.
Interventions	CrP 2 g bolus injection followed by 2‐hour infusion at the rate of 4g/h, a total of 10 gram vs isotonic sodium chloride infusion. Patients also received morphine for pain relief in both groups.
Outcomes	Outcomes on death, total myocardial infarction, hospitalization for heart failure, changes in blood pressure or ejection fraction were not reported. Main outcome: ventricular arrhythmia measured simultaneously with treatment with creatine phosphate or placebo. The heart rate was unchanged. The total number of ventricular premature beats (VPBs) during the Holter monitoring period (24 hours) was 690 ± 179 in the CrP group compared to 2468 ± 737 in the control group (p < 0.02); this was a result of a reduction in the number of complex forms of VPBs, the total number of single VPBs did not differ significantly between the two groups. During the CrP infusion period the total number of VPBs (18 ± 6 intervention vs 111 ± 41 controls), single VPBs (15 ± 5 vs 85 ± 33) , and paired VPBs (1.0 ± 0.4 vs. 9 ± 3) were significantly reduced compared to control (p < 0.05). During the monitoring period a significant reduction in the number of ventricular tachycardia paroxysms (VT) was found in favour of the CrP group (6 ± 2 vs 97 ± 35, p < 0.01). During the infusion period the mean number of VTs in the CrP group was 0.3 ± 0.1 vs 2 ± 1 (p < 0.05). The incidence of supraventricular extrasystoles was 846 ± 315 in the CrP group and 1012 ± 711 in the control group (not significant, p > 0.05).
Notes	Am Heart J. ;116(2 Pt 1):393‐7, Aug 1988
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "were randomized by means of sealed envelops". Method not further described but probably adequate.
Allocation concealment (selection bias)	Low risk	Quote: "sealed envelopes".
Blinding (performance bias and detection bias) All outcomes	High risk	Quote: "open‐label study".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Reasons of exclusion after randomization mentioned. Reason for inaccessible data mentioned. Quote: "Six tapes could not be analyzed because of technical problems; in two patients in the control group infusion of lidocaine was begun after ventricullar fibrillation, and the results were excluded from the analysis."
Selective reporting (reporting bias)	Unclear risk	The aim of the study was to assess the ability of CrP to reduce the incidence of arrythmias. Further specification is not mentioned in methods.
Other bias	High risk	(Side) effect attribution difficult because simultaneous usage of standard therapy.