CLINICAL TRIALS PROFILE FOR ARGATROBAN IN SODIUM CHLORIDE

All Clinical Trials for Argatroban In Sodium Chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00035178 ↗	Pharmacokinetics/Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease Patients Undergoing Hemodialysis	Completed	Texas Biotechnology Corporation	Phase 4	2002-05-01	The primary goals of this investigation are to provide guidance on how to dose Argatroban in patients undergoing hemodialysis and to assess the safety and tolerability of Argatroban in hemodialysis patients. The secondary goal of the study will be to assess the adequacy of anticoagulation during hemodialysis.
NCT00039858 ↗	Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin	Completed	GlaxoSmithKline	Phase 4	2003-09-01	The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.
NCT00039858 ↗	Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin	Completed	Encysive Pharmaceuticals	Phase 4	2003-09-01	The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.
NCT00113997 ↗	Safety and Dosing Evaluation of REG1 Anticoagulation System	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 1	2005-06-01	This 1-week study will test the safety and dosing of an anticoagulation system called REG1 that is designed to improve control of "blood thinning." Patients with heart attack and other conditions require treatment with an anticoagulant (blood thinner) to prevent the formation of blood clots. However, anticoagulation therapy can increase the risk of bleeding. The REG1 system is designed to minimize this risk. One part of the system stops the activity of factor IX (a protein that helps blood clot) while the other part of the system (the antidote) inactivates the drug and stops the thinning process. This study will examine in normal healthy subjects how the REG1 system works in the body and how it leaves the body. Healthy normal volunteers between 12 and 65 years of age who weigh 50-120 kilograms (110-264 pounds) and have no history of bleeding problems or significant bleeding may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests. Participants must avoid foods that may alter the blood's clotting ability and must not take any medications the week of the study. They undergo the following tests and procedures: Day 1 Subjects are admitted to the NIH Clinical Center for an overnight stay. Two catheters (plastic tubes) are placed in the subject's arm veins, one for drawing blood samples and the other for injecting one of the following: REG1 drug, REG1 antidote, REG1 drug and antidote, or placebo. Two injections of study medication are given, spaced 3 hours apart, each over a 1-minute period. After each injection, blood is collected at specific times to measure levels of the drug or antidote in the body and the blood's ability to clot. Subjects also provide a 24-hour urine collection and stool sample. Day 2 A blood sample is drawn 24 hours after the drug or antidote injection from the previous day. If the blood test result is normal, subjects are discharged home with instructions to follow. They return to the Clinical Center at 36 hours and 48 hours for additional blood samples. Days 3 and 7 A blood sample is collected at the end of day 3 and day 7. Urine and stool samples are also collected.
NCT00153946 ↗	Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke	Completed	Japan Cardiovascular Research Foundation	Phase 4	2004-08-01	Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and have frequently been used for the treatment of acute brain infarction in Japan. The effect of combination therapy of these drugs, however, has not yet been elucidated. This study will test the safety and efficacy of the combination therapy with these agents in patients with acute non-cardioembolic and non-lacunar ischemic stroke.

Clinical Trial Conditions for Argatroban In Sodium Chloride

Condition Name

Condition Name for Argatroban In Sodium Chloride
Intervention	Trials
Heparin-induced Thrombocytopenia	4
Stroke	3
Ischemic Stroke	3
CVD	2

Condition MeSH

Condition MeSH for Argatroban In Sodium Chloride
Intervention	Trials
Thrombocytopenia	10
Stroke	9
Ischemic Stroke	7
Ischemia	6

Clinical Trial Locations for Argatroban In Sodium Chloride

Trials by Country

Trials by Country for Argatroban In Sodium Chloride
Location	Trials
United States	75
Japan	12
China	10
Germany	9
France	4

Trials by US State

Trials by US State for Argatroban In Sodium Chloride
Location	Trials
Texas	6
Ohio	4
Massachusetts	4
Minnesota	4
Illinois	4

Clinical Trial Progress for Argatroban In Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Argatroban In Sodium Chloride
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Argatroban In Sodium Chloride
Clinical Trial Phase	Trials
Completed	18
Recruiting	8
Terminated	6

Clinical Trial Sponsors for Argatroban In Sodium Chloride

Sponsor Name

Sponsor Name for Argatroban In Sodium Chloride
Sponsor	Trials
Mitsubishi Tanabe Pharma Corporation	3
The University of Texas Health Science Center, Houston	3
GlaxoSmithKline	3

Sponsor Type

Sponsor Type for Argatroban In Sodium Chloride
Sponsor	Trials
Other	27
Industry	15
NIH	2

Argatroban in Sodium Chloride: Clinical Trials, Market Analysis, and Projections

Introduction

Argatroban, an anticoagulant or blood thinner, is widely used for the prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia (HIT) and other conditions. Here, we will delve into recent clinical trials, market analysis, and projections for argatroban in sodium chloride.

Clinical Trials and Efficacy

Early Neurological Deterioration and Stroke

A recent single-center study investigated the effectiveness of argatroban compared to dual antiplatelet therapy (DAPT) in patients with minor ischemic stroke (MIS). The study found that argatroban was effective in decreasing the rate of early neurological deterioration (END) and improving 7-day NIHSS scores. After propensity score matching, the argatroban subgroup showed a significantly lower END rate (6.8% vs 10.1%) and better functional outcomes at 7 days, although no significant difference was observed at 90 days[1].

Safety and Bleeding Events

Clinical trials have consistently shown that argatroban does not significantly increase the risk of major bleeding events compared to historical controls. In pivotal trials, no statistically significant differences in the incidence of major bleeding were observed between argatroban-treated patients and historical controls. Additionally, there were no cases of drug-related intracranial hemorrhage noted in these trials[3].

Monitoring and Dosage

Argatroban's anticoagulant activity is typically monitored using activated clotting time (ACT) during procedures like percutaneous coronary intervention (PCI). The dosage is adjusted to maintain a target ACT, and additional bolus doses may be administered as needed. This careful monitoring helps in achieving the desired anticoagulant effect without increasing the risk of bleeding[4].

Market Analysis

Market Size and Growth

The global argatroban market is projected to grow at a CAGR of 3.5% to 3.9% from 2022 to 2027. The market size is estimated to reach $1.65 billion by 2027. This growth is driven by the increasing prevalence of cardiovascular diseases, the need for anticoagulants in PCI procedures, and the rising incidence of heparin-induced thrombocytopenia[2][5].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the argatroban market, causing disruptions in supply chains and treatment protocols. However, the increased rate of thrombosis among COVID-19 patients also highlighted the importance of anticoagulants like argatroban. As vaccination campaigns progress and COVID-19 cases decline, the market is expected to reach its full potential[2].

Market Segmentation

The argatroban market can be segmented by product, application, and geography. The argatroban powder segment held the largest market share in 2021, while the argatroban injection segment is expected to grow with the fastest CAGR during the forecast period. The heparin-induced thrombocytopenia segment dominates the application segment, followed by PCI and cerebral arterial thrombosis. North America holds the largest share of the market, with the Asia-Pacific region expected to grow at the fastest CAGR[5].

Projections and Future Outlook

Increasing Demand in PCI Procedures

The demand for argatroban is expected to increase significantly as National Health Service (NHS) centers resume their operations of PCI procedures. The use of argatroban as an anticoagulant in adult patients with or at risk for HIT undergoing PCI will drive market growth[2].

Growing Prevalence of Peripheral Artery Disease

The increasing prevalence of peripheral artery disease (PAD), projected to affect 8.5 million persons in the United States by 2021, will also drive the demand for argatroban. This condition requires anticoagulant therapy, further propelling the growth of the argatroban market[2].

Safety and Efficacy Concerns

While argatroban offers significant benefits, its market growth may be restrained by side effects and related allergies. However, the overall safety profile and efficacy of argatroban are expected to maintain its position as a preferred anticoagulant in clinical settings[2][3].

Key Takeaways

• Clinical Efficacy: Argatroban has shown efficacy in reducing early neurological deterioration and improving functional outcomes in patients with minor ischemic stroke.
• Safety Profile: Argatroban does not significantly increase the risk of major bleeding events and is safe for use in patients with HIT.
• Market Growth: The global argatroban market is projected to grow at a CAGR of 3.5% to 3.9% from 2022 to 2027, driven by increasing demand in PCI procedures and the prevalence of cardiovascular diseases.
• Market Segmentation: The market is segmented by product, application, and geography, with North America holding the largest share and the Asia-Pacific region expected to grow the fastest.
• Future Outlook: The market is expected to grow due to the resumption of PCI procedures and the increasing prevalence of peripheral artery disease.

FAQs

What is argatroban used for?

Argatroban is used for the prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI)[4].

How is argatroban administered?

Argatroban is administered intravenously, with an initial infusion rate of 25 mcg/kg/min and a bolus dose of 350 mcg/kg. The dose is adjusted based on activated clotting time (ACT) to maintain the desired anticoagulant effect[4].

What are the common side effects of argatroban?

Common side effects of argatroban include mild gastrointestinal disturbances such as nausea and diarrhea. There is no significant increase in the risk of major bleeding events or intracranial hemorrhage[3].

How does the COVID-19 pandemic impact the argatroban market?

The COVID-19 pandemic caused disruptions in supply chains and treatment protocols but also highlighted the need for anticoagulants like argatroban due to the increased rate of thrombosis among COVID-19 patients. As the pandemic subsides, the market is expected to reach its full potential[2].

What is the projected market size of argatroban by 2027?

The global argatroban market is estimated to reach $1.65 billion by 2027, growing at a CAGR of 3.5% to 3.9% from 2022 to 2027[5].

Sources

1. Frontiers in Neurology: "The effect of argatroban on early neurological deterioration and..."
2. Mordor Intelligence: "Argatroban Market Size & Share Analysis - Industry Research Report"
3. Health Canada: "Argatroban for injection"
4. FDA: "Argatroban in Sodium Chloride Injection"
5. Industry ARC: "Argatroban Market Share, Size and Industry Growth Analysis 2020"

Last updated: 2025-01-02