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Single Bolus Recombinant Nonimmunogenic Staphylokinase (FORtelyzin) Versus Single Bolus Tenecteplase (Metalyse) in STEMI (FORMAT-1)

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ClinicalTrials.gov Identifier: NCT02301910
Recruitment Status : Unknown
Verified November 2014 by Supergene, LLC.
Recruitment status was:  Recruiting
First Posted : November 26, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Supergene, LLC

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Recombinant staphylokinase Drug: Tenecteplase Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Open Lable Randomized Comparative Study of Efficacy and Safety of Single Bolus Injection of Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Tenecteplase (Metalyse) in STEMI Patients
Study Start Date : October 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Recombinant staphylokinase
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
15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds
Other Name: Fortelyzin

Active Comparator: 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
  • 80 to <90 45 mg 9 ml
  • 90 50 mg 10 ml
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
Other Name: Metalyse




Primary Outcome Measures :
  1. Reperfusion Criteria of Fibrinolysis [ Time Frame: ECG at 90 min. after fibrinolysis, diagnostic coronary angiography ]
    • ST-segment resolution is ≥ 50 % in the qualifying lead (that had the maximum initial ST-segment elevation in the baseline ECG) in 90 min;
    • TIMI 2-3 or TFC 25-40 frames (for TIMI 3) and 41-60 frames (for TIMI 2) by coronary angiography


Secondary Outcome Measures :
  1. Cardiovascular Death+Reccurent MI+Stroke+Heart failure [ Time Frame: within 30 days after fibrinolysis ]
    Composite endpoint

  2. All cause death+Reccurent MI+Stroke+Heart failure [ Time Frame: within 30 days after fibrinolysis ]
    Composite endpoint

  3. Cardiovascular death [ Time Frame: within 30 days after fibrinolysis ]
    Death caused by any cardiovascular reason/event

  4. Repeated target vessel revascularization [ Time Frame: within 30 days after fibrinolysis ]
    The need for re-intervention on infarct-related artery within 30 days after fibrinolysis

  5. Development of Heart Failure [ Time Frame: within 30 days after fibrinolysis ]

    In case of at least of the one of the following conditions:

    1. Pulmonary oedema/congestion on chest X-ray without suspicion of a non-cardiac cause
    2. Rales > 1/3 up from the lung base (Killip class 2 or higher)
    3. Pulmonary capillary wedge pressure (PCWP) >25 mmHg
    4. Dyspnoea with pO2 < 80 mmHg or O2 sat < 90 % (no supplemental O2) in the absence of known lung disease;

  6. Rehospitalization due to cardiovascular reasons [ Time Frame: within 30 days after fibrinolysis ]
  7. Overall major and minor bleeding [ Time Frame: within 30 days after fibrinolysis ]
    According to TIMI classification

  8. Severe or life-threatining bleeding [ Time Frame: within 30 days after fibrinolysis ]
    According to GUSTO classification

  9. Overall bleeding [ Time Frame: within 30 gays after fibrinolysis ]
    GUSTO classification

  10. Intracranial haemorrhages [ Time Frame: within 30 days after fibrinolysis ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • both gender patients over 18 years
  • 12-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

Exclusion Criteria:

  • 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
  • cardiogenic shock (Killip class IV)
  • aortic aneurism
  • intracranial neoplasm
  • any head trauma within past 2 weeks
  • intracranial vessel malformation
  • recent administration of anticoagulant within the past month
  • INR >1.3
  • sensibilisation to staphylokinase
  • contra-indications to acetylsalicilic acid, clopidogrel, enoxaparin
  • any conditions with unfavorable prognosis
  • in case of surgical treatment required within 30 days after randomization
  • in case of unhallowed medications required
  • pregnancy, lactation
  • inability to follow the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301910


Contacts
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Contact: Valentin A. Markov, MD, Prof. +7 913 801-29-16 markov@cardio.tsu.ru

Locations
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Russian Federation
Institute of Cardiology Recruiting
Tomsk, Siberia, Russian Federation, 634012
Contact: Valentin A Markov, MD, Prof.    9138012916 ext +7    markov@cardio.tsu.ru   
Principal Investigator: Valentin A Markov, MD, Prof.         
St. Iosaf`s Belgorod Regional Clinical Hospital Not yet recruiting
Belgorod, Russian Federation, 308007
Contact: Janna Yu Chefranova, MD    4722504959 ext +7    jannaokbbel@rambler.ru   
Principal Investigator: Janna Yu Chefranova, MD         
Kemerovo cardiological dispensary Not yet recruiting
Kemerovo, Russian Federation, 650002
Contact: Olga L Barabash, MD    3842643308 ext +7    olb61@mail.ru   
Contact: L    9059696435 ext +7    olb61@mail.ru   
Principal Investigator: Olga Barabash, MD         
Research Institute of Complex Problems of Cardiovascular diseases Not yet recruiting
Kemerovo, Russian Federation, 650002
Contact: Vasiliy V Kashtalap, MD         
Principal Investigator: Vasiliy V Kashtalap, MD         
City Clinical Hospital #11 Not yet recruiting
Kemerovo, Russian Federation, 650014
Contact: Nikolay I Tarasov, MD    3842647496    tarassov53@mail.ru   
Principal Investigator: Nikolay I Tarasov, MD         
Russian national research medical University named after Pirogov Not yet recruiting
Moscow, Russian Federation, 117997
Contact: Ivan G Gordeev, MD, PhD         
Principal Investigator: Ivan G Gordeev, MD, PhD         
City Clinical Hospital #81 Not yet recruiting
Moscow, Russian Federation, 127644
Contact: Zaur S Shogenov, MD    4954835033 ext +7    zaurshogenov@yandex.ru   
Principal Investigator: Zaur S Shogenov, MD         
The Sklifosovsky Research institute of Emergency Not yet recruiting
Moscow, Russian Federation, 129090
Contact: Vladimir V Rezvan, MD    4956806722 ext +7    vladimir.rezvan@mail.ru   
Principal Investigator: Vladimir V Rezvan, MD         
Murmansk Regional Clinical Hospital Not yet recruiting
Murmansk, Russian Federation, 183047
Contact: Garry V Kleyn, MD, PhD         
Principal Investigator: Garry V Kleyn, MD, PhD         
City Clinical Hospital #5 Not yet recruiting
Nizhniy Novgorod, Russian Federation, 603005
Contact: Evgeny A Baranov, MD    8314365879 ext +7    orit@pharmnn.ru   
Principal Investigator: Evgeny A Baranov, MD         
Regional Clinical Hospital Not yet recruiting
Ryazan, Russian Federation, 390039
Contact: Sergey B Aksentiev, MD, PhD    4912214152 ext +7    aksentiev@mail.ru   
Principal Investigator: Sergey B Aksentiev, MD, PhD         
Samara Regional Clinical Cardiological Dispansery Not yet recruiting
Samara, Russian Federation, 44З070
Contact: Dmitry V Duplyacov, MD, PhD         
Principal Investigator: Dmitry V Duplyacov, MD, PhD         
Mariinsk City Hospital Not yet recruiting
St.-Petersburg, Russian Federation, 191014
Contact: Larisa V Scheglova, MD    8126050303 ext +7    shecheglovalar@mail.ru   
Principal Investigator: Larisa V Scheglova, MD         
Leningrad Regional Clinical Hospital Not yet recruiting
St.-Petersburg, Russian Federation, 194291
Contact: Alexander A Petrov, MD    8125923016 ext +7    cardiolokb@mail.ru   
Principal Investigator: Alexander A Petrov, MD         
Regional Clinical Hospital Not yet recruiting
Tver, Russian Federation, 170036
Contact: Dmitriy Yu Platonov, MD, PhD    4822555878 ext +7    diplato64@mail.ru   
Principal Investigator: Dmitriy Yu Platonov, MD, PhD         
City Clinical Hospital of Emergency #25 Not yet recruiting
Volgograd, Russian Federation, 400138
Contact: Eduard A Ponomarev, MD, PhD    8442585426 ext +7    ponomarev67@mail.ru   
Principal Investigator: Eduard A Ponomarev, MD, PhD         
Sponsors and Collaborators
Supergene, LLC
Investigators
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Principal Investigator: Valentin A. Markov, MD, Prof. Institute of Cardiology, Tomsk, Russia
Study Director: Segey S Markin, MD, Prof. Supergene LCC

Additional Information:
Publications:

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Responsible Party: Supergene, LLC
ClinicalTrials.gov Identifier: NCT02301910     History of Changes
Other Study ID Numbers: Fortelyzin-1
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by Supergene, LLC:
Myocardial Infarction
Fibrinolysis
Fortelyzin

Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tenecteplase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action