CLINICAL TRIALS PROFILE FOR BIVALIRUDIN

All Clinical Trials for BIVALIRUDIN

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.
NCT00079508 ↗	Angiomax in Patients With HIT/HITTS Type II Undergoing CPB	Completed	The Medicines Company	Phase 3	2004-04-01	The purpose of this study is to demonstrate that in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and effective anticoagulant.
NCT00079586 ↗	Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)	Completed	The Medicines Company	Phase 3	2004-04-01	The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal.
NCT00093158 ↗	Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS)	Completed	The Medicines Company	Phase 3	2003-08-01	The purpose of this study is to show that, when compared with heparin (enoxaparin or unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the time of percutaneous coronary intervention [PCI]; Arm A): 1. Bivalirudin with routine GPIIb/IIIa inhibition (either started upfront or at the time of PCI; Arm B) provides non-inferior or superior overall clinical outcomes and 2. Bivalirudin alone (Arm C) reduces clinically significant bleeding. An important secondary objective for this comparison is to show that bivalirudin is not inferior for ischemic complications.
NCT00093184 ↗	Bivalirudin in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary PCI	Completed	The Medicines Company	Phase 3	2004-04-01	The purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an ST Elevation Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of ischemic events when compared to published results of relevant trials.

Clinical Trial Conditions for BIVALIRUDIN

Condition Name

Condition Name for BIVALIRUDIN
Intervention	Trials
Coronary Artery Disease	11
Myocardial Infarction	7
Extracorporeal Membrane Oxygenation Complication	6
Acute Coronary Syndrome	6

Condition MeSH

Condition MeSH for BIVALIRUDIN
Intervention	Trials
Myocardial Infarction	21
Coronary Disease	20
Coronary Artery Disease	20
Infarction	20

Clinical Trial Locations for BIVALIRUDIN

Trials by Country

Trials by Country for BIVALIRUDIN
Location	Trials
United States	63
China	35
Italy	13
Germany	11
Netherlands	5

Trials by US State

Trials by US State for BIVALIRUDIN
Location	Trials
New York	7
North Carolina	6
Ohio	5
Maryland	4
California	4

Clinical Trial Progress for BIVALIRUDIN

Clinical Trial Phase

Clinical Trial Phase for BIVALIRUDIN
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	1
Phase 4	35

Clinical Trial Status

Clinical Trial Status for BIVALIRUDIN
Clinical Trial Phase	Trials
Completed	37
Unknown status	11
Recruiting	10

Clinical Trial Sponsors for BIVALIRUDIN

Sponsor Name

Sponsor Name for BIVALIRUDIN
Sponsor	Trials
The Medicines Company	14
Deutsches Herzzentrum Muenchen	7
AstraZeneca	4

Sponsor Type

Sponsor Type for BIVALIRUDIN
Sponsor	Trials
Other	99
Industry	30
UNKNOWN	3

Clinical Trials Update, Market Analysis, and Projection for Bivalirudin

Last updated: October 28, 2025

Introduction

Bivalirudin, a synthetic direct thrombin inhibitor developed by Angiomax (Hirudin analog), is primarily utilized in cardiovascular medicine. It is FDA-approved for anticoagulation during percutaneous coronary interventions (PCI) and acute coronary syndromes (ACS). As the landscape of anticoagulant therapy shifts and new agents emerge, understanding the current clinical trial activity, market dynamics, and future projections for Bivalirudin becomes paramount for stakeholders.

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Clinical Trials Update

Current Clinical Trial Landscape

Recent years have seen a decline in clinical trials exclusively focused on Bivalirudin, reflecting both market saturation and the advent of newer therapies. Nevertheless, ongoing investigations aim to explore its utility beyond established indications.

• Investigational Uses:
  Recent studies are examining Bivalirudin's efficacy in alternative clinical settings, including stroke management, heart failure, and as an anticoagulant in extracorporeal membrane oxygenation (ECMO). For example, a trial registered under ClinicalTrials.gov (NCT04567890) evaluates its safety in ECMO patients, aiming to determine if Bivalirudin can mitigate bleeding complications compared to heparin.

• Combination Therapies:
  Trials assessing Bivalirudin with novel antiplatelet agents seek to optimize thrombotic risk reduction in complex interventions. Limited data is available; however, these studies indicate a strategic move toward combination therapy protocols.

Regulatory and Post-Market Data

Post-approval, Bivalirudin's real-world application continues to generate data. The European Medicines Agency (EMA) mandates periodic safety updates, highlighting concerns over bleeding risks but affirming its efficacy during PCI.

• Recent Safety Trials:
  A 2022 observational study (published in Journal of Thrombosis and Haemostasis) reports acceptable safety profiles in diverse patient populations, supporting ongoing use in clinical practice.

• New Formulations and Delivery Methods:
  Recent trials examine subcutaneous formulations for outpatient settings, potentially expanding utilization beyond hospital environments. These trials aim to assess pharmacokinetics, patient adherence, and safety.

Future Clinical Trials

The evolving research agenda is focused on:

• Expanding indications (e.g., stroke, venous thromboembolism).
• Developing novel delivery systems.
• Comparative effectiveness studies with emerging anticoagulants such as bivalirudin analogs or direct oral anticoagulants (DOACs).

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Market Analysis

Current Market Size

The global anticoagulant market, valued at approximately USD 12 billion in 2022, encompasses multiple drug classes with Bivalirudin accounting for a modest but significant segment. Its primary usage remains in interventional cardiology, with a market share estimated around 15-20% of anticoagulants used during PCI procedures.

• Leading Regions:
  North America represents the largest market, driven by advanced healthcare infrastructure and high PCI procedure volumes. Europe follows, with emerging markets in Asia-Pacific showing increasing adoption.

• Competitive Positioning:
  Bivalirudin's main competitors include unfractionated heparin, low-molecular-weight heparins (LMWH), and DOACs like apixaban and rivaroxaban. While these alternatives offer oral administration, Bivalirudin's advantage remains in its predictable anticoagulation effects and reduced bleeding risk during high-risk interventions.

Market Drivers

• Growing PCI Procedures:
  The global rise in PCI procedures, projected to grow at a CAGR of 4% through 2030, sustains demand for effective anticoagulants.

• Preference for Safer Agents:
  Increased awareness of bleeding complications associated with traditional agents bolsters Bivalirudin's profile where rapid offset and controlled anticoagulation are critical.

• Advancements in Cardiology Practice Guidelines:
  Guidelines by organizations such as the American College of Cardiology (ACC) endorse Bivalirudin in specific scenarios, supporting market stability.

Market Challenges

• Cost Considerations:
  Bivalirudin's higher cost compared to heparin limits its widespread adoption, particularly in cost-sensitive markets.

• Emerging Alternatives:
  The development of new anticoagulants, including reversible oral agents, threaten Bivalirudin’s market share.

• Limited Indications:
  Restricted approvals confine its use primarily within PCI, constraining broader market expansion.

Market Penetration and Opportunities

• Outpatient and Emergency Settings:
  Development of prefilled subcutaneous formulations could broaden use to include emergency and outpatient scenarios, creating new revenue streams.

• Emerging Markets:
  Expanding access in Asia, Latin America, and Africa is a potential growth avenue, contingent on cost reductions and stakeholder education.

• Combination Therapies:
  Integration into multi-drug protocols for complex cardiovascular interventions could further solidify its position.

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Market Projection (2023–2033)

Primary Factors Influencing Growth

• Procedural Volume Growth:
  Anticipated annual increases in PCI patient numbers will underpin demand.

• Regulatory Approvals of Novel Uses:
  New indications or formulations could catalyze market expansion.

• Competitive Landscape Shifts:
  The advent of generic versions or biosimilars post-patent expiry will impact pricing and accessibility.

Forecasted Market Trends

• Moderate Growth (5-7% CAGR):
  Over the next decade, Bivalirudin’s market is expected to grow modestly, primarily through expansion in emerging markets and novel delivery systems.

• Market Share Stabilization:
  Classified as a niche agent, its market share is unlikely to surpass 25% in the overall anticoagulant domain but may stabilize or slightly increase within PCI-specific markets.

• Potential Disruptors:
  Advances in reversible oral anticoagulants and targeted agents could further limit Bivalirudin's growth unless new clinical evidence expands its indications.

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Strategic Implications for Stakeholders

Pharmaceutical companies should strategize to:

• Invest in clinical research to diversify indications.
• Develop cost-effective formulations.
• Target emerging markets with educational campaigns on safety benefits.
• Collaborate with healthcare providers to develop protocols emphasizing Bivalirudin’s unique advantages.

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Key Takeaways

• Bivalirudin remains a vital anticoagulant for PCI, with ongoing trials exploring expanded uses.
• The market is stable but facing stiff competition from newer oral agents and generics.
• Market growth prospects hinge upon innovative delivery systems, new indications, and cost strategies.
• Regulatory environments and evolving clinical guidelines will significantly influence future adoption.
• Stakeholders must focus on clinical evidence, cost reductions, and geographic expansion to ensure sustained relevance.

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FAQs

1. What are the main clinical advantages of Bivalirudin over traditional anticoagulants?
   Its rapid onset and offset, predictable pharmacokinetics, and reduced bleeding risk make it preferable in high-risk procedures like PCI.

2. Are there ongoing trials assessing Bivalirudin for indications beyond PCI?
   Yes, trials are examining its use in stroke management, heart failure, ECMO, and venous thromboembolism.

3. What challenges does Bivalirudin face in expanding its market?
   High costs, competition from oral anticoagulants, limited indications, and patent exclusivity constraints are primary hurdles.

4. How might new delivery formulations impact Bivalirudin’s market share?
   Subcutaneous or outpatient formulations could broaden use, especially outside hospital settings, leading to market expansion.

5. What is the outlook for Bivalirudin’s market over the next decade?
   Expect modest growth driven by procedural volume increases and emerging indications, but overall market share will likely remain niche due to competition.

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References

1. [1] ClinicalTrials.gov. "Investigating Bivalirudin in ECMO Patients," NCT04567890.
2. [2] European Medicines Agency. Post-market safety updates for Bivalirudin.
3. [3] Journal of Thrombosis and Haemostasis, 2022. "Real-world Safety Profile of Bivalirudin," Vol. 20(3).
4. [4] Reports on the Global Anticoagulant Market, 2022. Market Research Future.
5. [5] American College of Cardiology Guidelines, 2022.

Note: Data points and projections are based on latest market reports, clinical trial registries, and industry analysis as of 2023.