Clinical trials: Tenecteplase
ST Elevation Myocardial Infarction
Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction
GNR-060(JSC "GENERIUM", Russia) is a proposed biosimilar to the referent product Metalyse. This study is to compare the clinical efficacy and safety of GNR-060 vs Metalyse as a thrombolitic agent in patients with with ST…
- Trial name
- NCT05601999
- Testing
- GNR-060, Metalyse
- Where
- 11 sites in Russia
- Volunteers
- 244 people
- Sponsor
- AO GENERIUM
Myocardial Infarction
Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® in Korean Patients With Acute Myocardial Infarction
To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial infarction over a period of 6 years as required by Korean authorities, with the following observations: 1.
- Trial name
- NCT02206646
- Testing
- Metalyse
- Volunteers
- 987 people
- Sponsor
- Boehringer Ingelheim
Myocardial Infarction
A Trial on Efficacy and Safety of Full Dose Tenecteplase Combined With Unfractionated Heparin (UFH) or Enoxaparin in Acute Myocardial Infarction (AMI) in the Prehospital Setting
The primary objective of ASSENT 3 Plus (the same as for ASSENT 3) was to evaluate the safety and efficacy of full dose tenecteplase combined with unfractionated heparin (UFH, group A) and full dose tenecteplase combined with…
- Trial name
- ASSENT 3 Plus (NCT02181998)
- Testing
- Full dose tenecteplase, Unfractioned heparin, Enoxaparin
- Volunteers
- 1,606 people
- Sponsor
- Boehringer Ingelheim
Myocardial Infarction
A Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early Percutaneous Coronary Intervention (PCI) as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction (ASSENT 4 PCI)
To show whether addition of thrombolytic treatment by a single bolus injection of tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve the clinical outcome in patients with large acute…
- Trial name
- NCT00168792
- Testing
- Tenecteplase, PCI
- Where
- 176 sites in United States, Austria and 16 more
- Volunteers
- 1,671 people
- Sponsor
- Boehringer Ingelheim
Myocardial Infarction
Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation
Primary: To support the Regulatory Approval process of Metalyse® in Russian Federation. Secondary: To assess the efficacy and safety of single bolus of Metalyse® TNK-tissue plasminogen activator (TNK-tPA, Tenecteplase ) in…
- Trial name
- NCT02191670
- Testing
- METALYSE®
- Volunteers
- 60 people
- Sponsor
- Boehringer Ingelheim
Myocardial Infarction
Trial to Compare the Efficacy and Safety of a Single Bolus of TNK-tPA (Tenecteplase, Metalyse®) With Accelerated Infusion of Rt-PA (Alteplase, Actilyse®) in Asian Patients With Acute Myocardial Infarction
The objective of this trial was to compare the efficacy and safety of a single bolus of TNK-tPA (tenecteplase, Metalyse®) compared with rt-PA (alteplase, Actilyse®) in Asian patients.
- Trial name
- NCT00148460
- Testing
- TNK-tPA, rt-PA
- Where
- 18 sites in China, Hong Kong and 1 more
- Volunteers
- 270 people
- Sponsor
- Boehringer Ingelheim
Acute Myocardial Infarction
An Observational Study of TNKase in Patients Enrolled in the National Registry of Myocardial Infarction 4 and 5 (POST)
The POST study comprised patients whose data were entered into the NRMI 4 and 5 databases. NRMI is a prospective, observational study of patients presenting with AMI in the United States.
- Trial name
- NCT00669045
- Volunteers
- 253,668 people
- Sponsor
- Genentech, Inc.
THROMBOLYSIS
Tenecteplase in Stroke Patients Between 4.5 and 24 Hours
This study will evaluate the efficacy and safety of tenecteplase compared with placebo in participants with acute ischemic stroke (AIS).
- Trial name
- TIMELESS (NCT03785678)
- Testing
- Tenecteplase
- Where
- 97 sites in United States, Canada
- Volunteers
- 458 people
- Sponsor
- Genentech, Inc.
Dysfunctional Hemodialysis Catheters
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters
This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37 centers in the United States. 150 subjects ≥ 16 years of age who required hemodialysis (HD) and had a dysfunctional HD catheter were…
- Trial name
- TROPICS 3 (NCT00396032)
- Testing
- tenecteplase
- Volunteers
- 150 people
- Sponsor
- Genentech, Inc.
Dysfunctional Central Venous Access Catheters
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the United States and Canada. 251 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were enrolled in the study…
- Trial name
- TROPICS 2 (NCT00396318)
- Testing
- tenecteplase
- Volunteers
- 251 people
- Sponsor
- Genentech, Inc.
Dysfunctional Central Venous Access Catheters
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted at 24 centers in the United States and Canada.
- Trial name
- TROPICS 1 (NCT00395876)
- Testing
- tenecteplase
- Volunteers
- 100 people
- Sponsor
- Genentech, Inc.
Myocardial Infarction
Full Dose Tenecteplase (TNK-tPA) Together With Heparin Sodium, Full Dose Tenecteplase With Enoxaparin, Half Dose Tenecteplase Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction (AMI)
The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and half dose tenecteplase combined with…
- Trial name
- ASSENT 3 (NCT02181985)
- Testing
- Full dose TNK-tPA, Half dose TNK-tPA, Heparin
- Volunteers
- 5,989 people
- Sponsor
- Boehringer Ingelheim
Dysfunctional Hemodialysis Catheters
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters
This was a Phase III, open-label study conducted at 44 centers in the United States, Canada, and Puerto Rico. 223 subjects who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.
- Trial name
- TROPICS 4 (NCT00396253)
- Testing
- Tenecteplase
- Volunteers
- 223 people
- Sponsor
- Genentech, Inc.
Myocardial Infarction
Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI
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…
- Trial name
- FRIDOM1 (NCT02301910)
- Testing
- Recombinant staphylokinase, Tenecteplase
- Where
- 17 sites in Russia
- Volunteers
- 382 people
- Sponsor
- Supergene, LLC
Myocardial Infarction
A Study to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With Acute Myocardial Infarction (AMI)
Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2 hours after the start of treatment versus…
- Trial name
- NCT02182011
- Testing
- Tenecteplase, Alteplase, Streptokinase
- Volunteers
- 49 people
- Sponsor
- Boehringer Ingelheim
Myocardial Infarction
Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Early Inhospital Thrombolysis With Metalyse
Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse® in a real life setting outside clinical…
- Trial name
- NCT02194153
- Testing
- Metalyse weight-adjusted
- Volunteers
- 351 people
- Sponsor
- Boehringer Ingelheim
Heart Arrest
Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial
The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.
- Trial name
- NCT00157261
- Testing
- tenecteplase
- Where
- 68 sites in Austria, Belgium and 7 more
- Volunteers
- 1,050 people
- Sponsor
- Boehringer Ingelheim
Myocardial Infarction
STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community…
- Trial name
- NCT00623623
- Testing
- primary PCI, enoxaparin, catheterisation
- Where
- 201 sites in Austria, Belgium and 14 more
- Volunteers
- 1,899 people
- Sponsor
- Boehringer Ingelheim
Stroke
A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
This study is open to Chinese adults who had an ischaemic stroke, which means that blood vessels in the brain are blocked. To resolve blood clots, people in the study get either tenecteplase or alteplase within 4 hours and 30…
- Trial name
- ORIGINAL (NCT04915729)
- Testing
- tenecteplase, alteplase
- Where
- 55 sites in China
- Volunteers
- 1,489 people
- Sponsor
- Boehringer Ingelheim
Acute Ischemic Stroke
A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well
This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke).
- Trial name
- TENACITY (NCT07361302)
- Testing
- Tenecteplase, Standard of care treatment
- Where
- 257 sites in Argentina, Australia and 14 more
- Volunteers
- 1,325 people
- Sponsor
- Boehringer Ingelheim