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Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI

NCT02301910 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2025-03-20

Study results available
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Summary

The aim of the study is to determine if single-bolus recombinant nonimmunogenic staphylokinase is effective and save thrombolytic agent in patients presenting ST-segment elevation myocardial infarction in comparison to tenecteplase.

Conditions

Interventions

DRUG

Recombinant staphylokinase

15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds

DRUG

Tenecteplase

50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml

Sponsors & Collaborators

  • Supergene, LLC

    lead INDUSTRY

Principal Investigators

  • Valentin A. Markov, MD, Prof. · Institute of Cardiology, Tomsk, Russia

  • Segey S Markin, MD, Prof. · Supergene LCC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-16
Primary Completion
2016-12-01
Completion
2016-12-01

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02301910 on ClinicalTrials.gov