Alteplase

Generic Name
Alteplase
Brand Names
Activase, Cathflo, Cathflo Activase
Drug Type
Biotech
Chemical Formula
-
CAS Number
105857-23-6
Unique Ingredient Identifier
1RXS4UE564
Background

Alteplase is a recombinant tissue plasminogen activator (rt-PA) used as a thrombolytic agent. It cleaves plasminogen to form plasmin, an enzyme involved in the degradation of fibrin clots. In the absence of fibrin, the alteplase-mediated conversion of plasminogen is limited, thanks to the high affinity between alteplase and fibrin. Alteplase is a purified glycoprotein of 527 amino acids expressed in Chinese hamster ovary (CHO) cells. It was first approved by the FDA in 1987 for the management of thromboembolic disease, including acute myocardial infarction (AMI). The use of alteplase to manage AMI has decreased thanks to the availability of safer treatments such as angioplasty and stenting. However, its use for the treatment of acute ischemic stroke (AIS) has increased over the years. New thrombolytic agents derived from tissue plasminogen activator, such as desmoteplase, tenecteplase and reteplase, have also been developed. Alteplase is also available as Cathflo Activase (intracatheter instillation) for the restoration of function to central venous access devices.

Indication

Alteplase is indicated for the treatment of acute ischemic stroke (AIS) and for use in acute myocardial infarction (AMI) for the reduction of mortality and incidence of heart failure. Alteplase is also indicated for the lysis of acute massive pulmonary embolism, defined as acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments, and acute pulmonary emboli accompanied by unstable hemodynamics.

Associated Conditions
Acute Ischemic Stroke, Cardiac mortality, Heart Failure, Pulmonary Embolism Acute Massive, Central venous access device thrombosis
Associated Therapies
-

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

First Posted Date
2008-11-02
Last Posted Date
2018-12-05
Lead Sponsor
Johns Hopkins University
Target Recruit Count
500
Registration Number
NCT00784134
Locations
🇺🇸

Springfield Neurological and Spine Institute, Springfield, Missouri, United States

🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

University of Maryland, Baltimore, Maryland, United States

and more 78 locations

Low Dosage of rt-PA in the Treatment of Pulmonary Thromboembolism in China

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-10-29
Last Posted Date
2008-10-29
Lead Sponsor
Beijing Chao Yang Hospital
Target Recruit Count
118
Registration Number
NCT00781378
Locations
🇨🇳

The Second Affiliated Hospital of Hebei University, Shijiazhuang, Hebei, China

🇨🇳

Shenyang Military Hospital, Shenyang, Liaoning, China

🇨🇳

The Affiliated Hospital of Shenyang Medical University, Shenyang, Liaoning, China

and more 20 locations

Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas

First Posted Date
2007-05-02
Last Posted Date
2012-04-30
Lead Sponsor
Midwest Pulmonary and Critical Care
Target Recruit Count
100
Registration Number
NCT00468104
Locations
🇺🇸

Nebraska Methodist Hospital, Omaha, Nebraska, United States

Safety and Effectiveness of tPA in Intra-abdominal Abscesses

First Posted Date
2007-01-04
Last Posted Date
2014-01-14
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
35
Registration Number
NCT00417768
Locations
🇨🇦

University Health Network, Toronto, Ontario, Canada

Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Japan Alteplase Clinical Trial Ⅱ:J-ACT Ⅱ)

Phase 4
Completed
Conditions
Interventions
First Posted Date
2006-12-19
Last Posted Date
2018-01-19
Lead Sponsor
Mitsubishi Tanabe Pharma Corporation
Target Recruit Count
58
Registration Number
NCT00412867
Locations
🇯🇵

Investigational site 01, Hokkaido, Japan

Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

First Posted Date
2006-02-01
Last Posted Date
2015-02-26
Lead Sponsor
Kaiser Permanente
Target Recruit Count
20
Registration Number
NCT00284739
Locations
🇺🇸

Kaiser Foundation Hospital, Honolulu, Hawaii, United States

Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke

First Posted Date
2006-01-27
Last Posted Date
2011-01-12
Lead Sponsor
University of California, San Diego
Target Recruit Count
130
Registration Number
NCT00283088
Locations
🇺🇸

Herman Memorial Hospital, Houston, Texas, United States

🇺🇸

Hartford Hospital, Hartford, Connecticut, United States

🇺🇸

Saint Louis University Medical Center, St. Louis, Missouri, United States

and more 4 locations

Safety and Efficacy of Tissue Plasminogen Activator (tPA) in Neonates and Infants

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2005-12-13
Last Posted Date
2018-04-04
Lead Sponsor
University of Louisville
Target Recruit Count
12
Registration Number
NCT00265005
Locations
🇺🇸

University of Louisville, Louisville, Kentucky, United States

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

Phase 3
Completed
Conditions
First Posted Date
2005-09-08
Last Posted Date
2013-10-29
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
270
Registration Number
NCT00148460
Locations
🇰🇷

Dongsan Medical Center, Jung-Ku, Korea, Republic of

🇰🇷

Chunnam University Hospital, Kwang-Ju, Korea, Republic of

🇨🇳

Beijing University, Beijing, China

and more 15 locations

Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke

Phase 3
Completed
Conditions
Interventions
First Posted Date
2005-09-07
Last Posted Date
2012-03-01
Lead Sponsor
Mitsubishi Tanabe Pharma Corporation
Target Recruit Count
103
Registration Number
NCT00147316
Locations
🇯🇵

National Cardiovascular Center, Suita, Osaka, Japan

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