CompletedPhase 3

Efficacy and Safety Study of Proposed Biosimilar Product Reveliza vs Actilise in Patients With ST-segment Elevation Myocardial Infarction

Russia180 participantsStarted 2014-05-25

Plain-language summary

Thi is is a multi-center, randomized, single-blind, parallel group clinical trial to evaluate the efficacy and safety of the intravenious thrombolysis with Revelise® (GENERIUM, Russia) in comparosin with the Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) in patients with acute myocardial infarction (MI) with ST-segment elevation on the electrocardiogram (ECG). The thrombolisis was performed within the period of up to 6 hours and from 6 to 12 hours from the MI symptoms onset.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age between 18 and 80 years
✓. Acute myocardial infarction with ST-segment elevation on ECG (point J) in 2 or more consecutive leads of more than 0.2 mV in men or more than 0.15 mV in women in leads V2-V3 or more than 0.1 mV in other leads after not more than 12 hours from pain onset (lasting at least 20 minutes) in chest (at the time of screening).
✓. Written informed consent of the patient for participation in the trial and conduction of coronary angiography.

What they're measuring

Myocardial reperfusion rate confirmed by the coronary angiography (CAG)

Timeframe: In 3 hours after the beginning of IV thrombolysis in case of ECG data of successful reperfusion and immediately - if there is no effect of thrombolysis based on ECG data.

Trial details

NCT IDNCT07146360

SponsorAO GENERIUM

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-21

View on ClinicalTrials.gov More Myocardial Infarction (MI) trials