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

NCT02301910 | Completed Phase 3 Results

• 1 other identifier: FRIDOM1
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 17

Brief 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

Myocardial Infarction

Keywords

Myocardial Infarction; Fibrinolysis; Fortelyzin

Outcome Measures

Primary Outcomes (1)

• The Number of Participants With Reperfusion

  The number of participants with reperfusion by TIMI (Thrombolysis in Myocardial Infarction) 2-3 assessed by coronary arteriography, where grade 0 - no perfusion, grade 1 - penetration without perfusion, grade 2 - partial perfusion, grade 3 - complete perfusion.

  90 min after fibrinolysis

Secondary Outcomes (7)

• Composite Endpoint

  within 30 days after fibrinolysis

• Cardiovascular Death

  within 30 days after fibrinolysis

• Repeated Target Vessel Revascularization

  within 30 days after fibrinolysis

• Development of Heart Failure

  within 30 days after fibrinolysis

• Rehospitalization Due to Cardiovascular Reasons

  within 30 days after fibrinolysis

Study Arms (2)

Recombinant staphylokinase

EXPERIMENTAL

Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 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: Recombinant staphylokinase

Tenecteplase

ACTIVE COMPARATOR

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 * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml

Drug: Tenecteplase

Interventions

Recombinant staphylokinase DRUG

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

Also known as: Fortelyzin

Recombinant staphylokinase

Tenecteplase DRUG

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

Also known as: Metalyse

Tenecteplase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both gender patients over 18 years
• lead ECG indicative of an STEMI (ST-segment elevation in acute myocardial infarction, measured at the J point, should be found in two contiguous leads and be ≥0.25 mV in men below the age of 40 years, ≥0.2 mV in men over the age of 40 years, or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads (in the absence of left ventricular hypertrophy or left bundle branch block
• the possibility of fibrinolysis within 12 hour of symptom onset
• inability of primary PCI within 60 min of first medical contact (FMC)
• informed consent received

You may not qualify if:

• expected performance of PCI less 60 min from FMC
• left bundle branch block or ventricular pacing
• cases of sinus bradycardia associated with hypotension, AV block II (Mobitz 2) or AV block III with bradycardia that causes hypotension or heart failure
• active bleeding or known bleeding disorders/diathesis
• uncontrolled hypertension, defined us single blood pressure measurement ≥180/110 mm Hg prior to randomization
• internal bleeding within the past 2 weeks
• conditions with increased risk of bleeding (peptic ulceration)
• prolonged or traumatic resuscitation within the past 2 weeks
• any known history of hemorrhagic stroke, or transitory ischemic attack
• ischemic stroke within the past 3 month
• puncture of unpressable vessels
• aortic aneurism
• intracranial neoplasm
• any head trauma within past 2 weeks
• intracranial vessel malformation

Sponsors & Collaborators

• Supergene, LLC: lead

Study Sites (17)

Institute of Cardiology

Tomsk, Siberia, 634012, Russia

Location

St. Iosaf's Belgorod Regional Clinical Hospital

Belgorod, 308007, Russia

Location

Kemerovo cardiological dispensary

Kemerovo, 650002, Russia

Location

Research Institute of Complex Problems of Cardiovascular diseases

Kemerovo, 650002, Russia

Location

City Clinical Hospital #11

Kemerovo, 650014, Russia

Location

Russian national research medical University named after Pirogov

Moscow, 117997, Russia

Location

City Clinical Hospital #81

Moscow, 127644, Russia

Location

The Sklifosovsky Research institute of Emergency

Moscow, 129090, Russia

Location

Murmansk Regional Clinical Hospital

Murmansk, 183047, Russia

Location

City Clinical Hospital #5

Nizhny Novgorod, 603005, Russia

Location

Regional Clinical Hospital

Ryazan, 390039, Russia

Location

Mariinsk City Hospital

Saint Petersburg, 191014, Russia

Location

Leningrad Regional Clinical Hospital

Saint Petersburg, 194291, Russia

Location

Samara Regional Clinical Cardiological Dispansery

Samara, 44З070, Russia

Location

Regional Clinical Hospital

Tver', 170036, Russia

Location

Citi Clinical Hospital # 4

Vladimir, 600020, Russia

Location

City Clinical Hospital of Emergency #25

Volgograd, 400138, Russia

Location

Related Publications (9)

• Armstrong PW, Gershlick A, Goldstein P, Wilcox R, Danays T, Bluhmki E, Van de Werf F; STREAM Steering Committee. The Strategic Reperfusion Early After Myocardial Infarction (STREAM) study. Am Heart J. 2010 Jul;160(1):30-35.e1. doi: 10.1016/j.ahj.2010.04.007.

  PMID: 20598969 BACKGROUND

• Van de Werf F, Cannon CP, Luyten A, Houbracken K, McCabe CH, Berioli S, Bluhmki E, Sarelin H, Wang-Clow F, Fox NL, Braunwald E. Safety assessment of single-bolus administration of TNK tissue-plasminogen activator in acute myocardial infarction: the ASSENT-1 trial. The ASSENT-1 Investigators. Am Heart J. 1999 May;137(5):786-91. doi: 10.1016/s0002-8703(99)70400-x.

  PMID: 10220625 BACKGROUND

• Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators; Van De Werf F, Adgey J, Ardissino D, Armstrong PW, Aylward P, Barbash G, Betriu A, Binbrek AS, Califf R, Diaz R, Fanebust R, Fox K, Granger C, Heikkila J, Husted S, Jansky P, Langer A, Lupi E, Maseri A, Meyer J, Mlczoch J, Mocceti D, Myburgh D, Oto A, Paolasso E, Pehrsson K, Seabra-Gomes R, Soares-Piegas L, Sugrue D, Tendera M, Topol E, Toutouzas P, Vahanian A, Verheugt F, Wallentin L, White H. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial. Lancet. 1999 Aug 28;354(9180):716-22. doi: 10.1016/s0140-6736(99)07403-6.

  PMID: 10475182 BACKGROUND

• Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 Investigators. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction. Lancet. 2001 Aug 25;358(9282):605-13. doi: 10.1016/S0140-6736(01)05775-0.

  PMID: 11530146 BACKGROUND

• Wallentin L, Goldstein P, Armstrong PW, Granger CB, Adgey AA, Arntz HR, Bogaerts K, Danays T, Lindahl B, Makijarvi M, Verheugt F, Van de Werf F. Efficacy and safety of tenecteplase in combination with the low-molecular-weight heparin enoxaparin or unfractionated heparin in the prehospital setting: the Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 PLUS randomized trial in acute myocardial infarction. Circulation. 2003 Jul 15;108(2):135-42. doi: 10.1161/01.CIR.0000081659.72985.A8. Epub 2003 Jul 7.

  PMID: 12847070 BACKGROUND

• Vanderschueren S, Dens J, Kerdsinchai P, Desmet W, Vrolix M, De Man F, Van den Heuvel P, Hermans L, Collen D, Van de Werf F. Randomized coronary patency trial of double-bolus recombinant staphylokinase versus front-loaded alteplase in acute myocardial infarction. Am Heart J. 1997 Aug;134(2 Pt 1):213-9. doi: 10.1016/s0002-8703(97)70127-3.

  PMID: 9313600 BACKGROUND

• Verstraete M. Third-generation thrombolytic drugs. Am J Med. 2000 Jul;109(1):52-8. doi: 10.1016/s0002-9343(00)00380-6.

  PMID: 10936478 BACKGROUND

• Collaborative Research Group of Reperfusion Therapy in Acute Myocardial Infarction. [A randomized multicenter trial comparing recombinant staphylokinase with recombinant tissue-type plasminogen activator in patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2007 Aug;35(8):691-6. Chinese.

  PMID: 17963623 BACKGROUND

• Collen D. Staphylokinase: a potent, uniquely fibrin-selective thrombolytic agent. Nat Med. 1998 Mar;4(3):279-84. doi: 10.1038/nm0398-279. No abstract available.

  PMID: 9500599 BACKGROUND

Related Links

• Efficacy Guidelines. The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials.

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Markin Sergey
• Organization: SuperGene LLC

info@supergene.ru

(495) 287-98-07

Study Officials

• Valentin A. Markov, MD, Prof.

  Institute of Cardiology, Tomsk, Russia

  PRINCIPAL INVESTIGATOR

• Segey S Markin, MD, Prof.

  Supergene LCC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: May 16, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (17)