CLINICAL TRIALS PROFILE FOR BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

All Clinical Trials for Bivalirudin In 0.9% Sodium Chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00043277 ↗	Study Of Angiomax In Infants Under Six Months With Thrombosis	Completed	The Medicines Company	Phase 2	2002-08-01	The goals of this study are: 1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis; 2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis; 3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
NCT00043940 ↗	Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia (AT BAT, First Inning)	Completed	The Medicines Company	Phase 3	1999-04-01	Primary Objective: To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). This will be measured by the composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin (or at hospital discharge, whichever occurs first). The components of the composite endpoint are: a) intracranial bleeding; b) retroperitoneal bleeding; c) bleeding that results in hemodynamic compromise; d) bleeding that requires transfusion of three or more units of whole blood or packed red cells; and e) a decrease in hemoglobin of greater than or equal to g/dL or in hematocrit of greater than or equal to 9%. Secondary Objectives: Each component of the primary composite endpoint. To evaluate the level of anticoagulation achieved with bivalirudin. The goal is to achieve an activated clotting time (ACT) between 300 and 350 sec during PCI and 4-hour bivalirudin infusion. To evaluate bivalirudin's effects on platelet counts.
NCT00073593 ↗	Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB	Completed	The Medicines Company	Phase 3	2003-08-01	The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery.

Clinical Trial Conditions for Bivalirudin In 0.9% Sodium Chloride

Condition Name

Condition Name for Bivalirudin In 0.9% Sodium Chloride
Intervention	Trials
Coronary Artery Disease	11
Myocardial Infarction	7
Acute Coronary Syndrome	6

Condition MeSH

Condition MeSH for Bivalirudin In 0.9% Sodium Chloride
Intervention	Trials
Myocardial Infarction	21
Coronary Artery Disease	20
Infarction	20

Clinical Trial Locations for Bivalirudin In 0.9% Sodium Chloride

Trials by Country

Trials by Country for Bivalirudin In 0.9% Sodium Chloride
Location	Trials
United States	63
China	33
Italy	12
Germany	11
Netherlands	5

Trials by US State

Trials by US State for Bivalirudin In 0.9% Sodium Chloride
Location	Trials
New York	7
North Carolina	6
Ohio	5
Maryland	4
California	4

Clinical Trial Progress for Bivalirudin In 0.9% Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Bivalirudin In 0.9% Sodium Chloride
Clinical Trial Phase	Trials
Phase 4	35
Phase 3	21
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Bivalirudin In 0.9% Sodium Chloride
Clinical Trial Phase	Trials
Completed	37
Unknown status	11
Terminated	8

Clinical Trial Sponsors for Bivalirudin In 0.9% Sodium Chloride

Sponsor Name

Sponsor Name for Bivalirudin In 0.9% Sodium Chloride
Sponsor	Trials
The Medicines Company	14
Deutsches Herzzentrum Muenchen	7
AstraZeneca	4

Sponsor Type

Sponsor Type for Bivalirudin In 0.9% Sodium Chloride
Sponsor	Trials
Other	86
Industry	30
NIH	1

Bivalirudin in 0.9% Sodium Chloride: Clinical Trials, Market Analysis, and Projections

Introduction

Bivalirudin, a direct thrombin inhibitor, has emerged as a critical anticoagulant in various medical procedures, particularly in percutaneous coronary interventions (PCI) and the management of heparin-induced thrombocytopenia (HIT). Here, we delve into the clinical trials, market analysis, and future projections for bivalirudin.

Clinical Trials Experience

Bivalirudin Angioplasty Trial (BAT)

The BAT trials were pivotal in establishing bivalirudin's efficacy and safety. In these trials, patients with unstable angina undergoing PCI were randomized to receive either bivalirudin or heparin. The results showed that bivalirudin was superior to heparin in reducing the incidence of death, myocardial infarction (MI), abrupt closure of the dilated vessel, or clinical deterioration requiring revascularization or placement of an aortic balloon pump during hospitalization up to seven days[1].

Adverse Reactions and Safety Profile

In the BAT trials, 3.7% of subjects receiving bivalirudin experienced significant bleeding events, including intracranial bleeding, retroperitoneal bleeding, and clinically overt bleeding. However, the overall bleeding risk was found to be lower with bivalirudin compared to heparin. Postmarketing reports have also highlighted rare but serious adverse reactions such as fatal bleeding, hypersensitivity reactions, and thrombus formation during PCI[1].

Immunogenicity

Clinical trials have shown that bivalirudin has a low immunogenic potential. Among 494 subjects tested for antibodies, only two had treatment-emergent positive bivalirudin antibody tests, and neither demonstrated clinical evidence of allergic or anaphylactic reactions[1].

Market Analysis

Growing Demand in PCI Procedures

The increasing prevalence of acute coronary syndrome globally is driving the demand for PCI procedures, which in turn is boosting the use of bivalirudin as an anticoagulant. Bivalirudin's advantages over heparin, such as predictable pharmacokinetics and reduced bleeding risk, make it a preferred choice for these procedures[2][3].

Market Segmentation

The bivalirudin market is segmented based on dosage forms (ready-to-use solution and powder for reconstitution), applications (PCI and PTCA procedures), and end-use (hospitals and drug stores). The market is expected to grow due to the expanding use of bivalirudin in broader therapeutic indications, particularly in regions with rising PCI procedures[2][3].

Competitive Landscape

Despite its advantages, the high cost of bivalirudin is a significant barrier to its widespread adoption. The market faces competitive pressure from alternative anticoagulants, including biosimilars and generics. Efforts to reduce costs and improve delivery mechanisms are crucial for market expansion[2][3].

Market Projections

Current Market Size and Growth

The global bivalirudin market was valued at USD 1.23 billion in 2023 and is expected to reach USD 1.31 billion in 2024. It is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030, reaching USD 887.2 million by 2030[3][5].

Key Growth Factors

The market growth is driven by several factors, including the increasing prevalence of cardiovascular diseases, advancements in drug delivery systems, and growing awareness about safer anticoagulant options. Expanding approvals and increasing usage in broader therapeutic indications, particularly in emerging markets, also contribute to the growth[3].

Challenges and Opportunities

While the high cost of therapy and competitive pressure from alternative anticoagulants pose challenges, opportunities lie in enhancing bivalirudin formulations for extended shelf life and improved delivery mechanisms. Further research in combination therapies and optimizing supply chain strategies can improve cost efficiency and accessibility, especially in low-income markets[3].

Use in Special Populations

Pediatric Use

Bivalirudin has emerged as an alternative to heparin for anticoagulation in infants and children, particularly in cases of heparin-induced thrombocytopenia (HIT). Studies have shown a significant reduction in bleeding rates when using bivalirudin compared to other direct thrombin inhibitors like argatroban. The first pilot study on using bivalirudin in infants was presented in 2007, and subsequent research has supported its safe and effective use in pediatric patients undergoing cardiac catheterization[2].

Renal Impairment

Bivalirudin's clearance is reduced in patients with renal impairment, necessitating dose adjustments. In patients with moderate and severe renal impairment, the clearance is reduced by 21% and 70%, respectively, with corresponding increases in half-life. This highlights the need for careful dosing in patients with renal insufficiency[1][4].

Regulatory and Cost Considerations

Regulatory Landscape

The evolving regulatory landscape adds complexity to the market expansion of bivalirudin. Pharmaceutical companies must stay abreast of regulatory shifts and invest strategically in research and development to leverage unmet clinical needs[3].

Cost and Accessibility

The high cost of bivalirudin restricts its use among patients with low or moderate risk of bleeding. Various healthcare institutions are focusing on cost-saving initiatives to reduce the cost and wastage of bivalirudin by providing dosages based on the patient's condition[2][3].

Key Takeaways

• Clinical Efficacy: Bivalirudin has demonstrated superiority over heparin in reducing adverse outcomes in PCI procedures.
• Market Growth: The global bivalirudin market is projected to grow at a CAGR of 6.5% from 2024 to 2030.
• Special Populations: Bivalirudin is a viable alternative for anticoagulation in infants and children and requires careful dosing in patients with renal impairment.
• Challenges: High cost and competitive pressure from alternative anticoagulants are significant barriers to market expansion.
• Opportunities: Enhancing formulations, improving delivery mechanisms, and optimizing supply chain strategies can drive future growth.

FAQs

What are the primary uses of bivalirudin?

Bivalirudin is primarily used as an anticoagulant in percutaneous coronary interventions (PCI) and for the management of heparin-induced thrombocytopenia (HIT).

How does bivalirudin compare to heparin in terms of bleeding risk?

Bivalirudin has been shown to have a lower bleeding risk compared to heparin, particularly in PCI procedures.

What are the key growth factors for the bivalirudin market?

The market growth is driven by the increasing prevalence of cardiovascular diseases, advancements in drug delivery systems, and growing awareness about safer anticoagulant options.

How does renal impairment affect bivalirudin dosing?

Bivalirudin's clearance is reduced in patients with renal impairment, necessitating dose adjustments to avoid adverse effects.

What are the challenges facing the bivalirudin market?

The high cost of therapy and competitive pressure from alternative anticoagulants, including biosimilars and generics, are significant challenges to market expansion.

Sources

1. Drugs.com: Bivalirudin: Package Insert / Prescribing Information.
2. Biospace: Bivalirudin Drug Market New Development and Competitive Analysis Report.
3. GIIR Research: Bivalirudin Market by Dosage Form, Application, End-Use - Global.
4. SESLHD: Bivalirudin for Heparin induced thrombocytopenia (HIT).
5. Drug Patent Watch: Generic BIVALIRUDIN INN entry, pharmaceutical patent expiration.