NCT02301910 (FRIDOM1) is a Phase 3 clinical trial of Recombinant staphylokinase in Myocardial Infarction, sponsored by Supergene, LLC.

Who is sponsoring NCT02301910?

NCT02301910 is sponsored by Supergene, LLC.

What drugs are being tested in NCT02301910?

Interventions in NCT02301910: Recombinant staphylokinase, Tenecteplase.

What condition does NCT02301910 study?

NCT02301910 studies Myocardial Infarction.

Is NCT02301910 still recruiting?

NCT02301910 is currently completed. Last updated 20 March 2025.

Are results published for NCT02301910?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-20 · How we verify

NCT02301910: FRIDOM1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 20 March 2025

What this trial tests

Phase 3 trial testing Recombinant staphylokinase in Myocardial Infarction in 382 participants. Completed in 1 December 2016.

Timeline

16 May 2014

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	Supergene, LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	382
Start date	16 May 2014
Primary completion	1 December 2016
Estimated completion	1 December 2016
Sites	17 locations across Russia

Drugs / interventions tested

Recombinant staphylokinase — full drug profile →
Tenecteplase (TENECTEPLASE) — full drug profile →

Conditions studied

Myocardial Infarction — all drugs for Myocardial Infarction →

Sponsor

Supergene, LLC — full company profile →

Who can join

18 and older, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Recombinant staphylokinase

Trials testing the same drug.

NCT05410925 — Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction · Phase 4 · recruiting
NCT03151993 — Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS · Phase 3 · completed

Other recruiting trials for Myocardial Infarction

Currently open trials in the same condition.

NCT07257198 — Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone · Phase 3 · recruiting
NCT07402642 — Effect of Early Educational Intervention on Cardiovascular Risk Factors After Acute Coronary Syndrome · NA · recruiting
NCT07301034 — A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, · Phase 3 · recruiting
NCT07142265 — Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients · recruiting
NCT07138911 — Effect of Home-based Exercise Plan Mediated by Use of Digital Health App on Kinesiophobia and Functional Capacity · NA · recruiting

Other Supergene, LLC trials

Trials by the same sponsor.

NCT07324837 — Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset · Phase 3 · not yet recruiting
NCT07245927 — Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism · recruiting
NCT06362746 — Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism · Phase 3 · recruiting
NCT05372718 — Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial · Phase 3 · recruiting
NCT05135546 — Inhaled Recombinant Non-immunogenic Staphylokinase vs Placebo in Patients With COVID-19 - FORRIF Trial · Phase 2, PHASE3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02301910 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Supergene, LLC
Last refreshed: 20 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02301910.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing