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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR ANGIOMAX RTU


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All Clinical Trials for Angiomax Rtu

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).
NCT00073580 ↗ Angiomax in Patients With HIT/HITTS Type II Undergoing Off-Pump Coronary Artery Bypass Grafting (CABG) (CHOOSE) Completed The Medicines Company Phase 3 2003-10-01 The purpose of this study is to examine the safety and efficacy of Angiomax as an anticoagulation in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia with thrombosis syndrome (HITTS) undergoing off-pump coronary artery bypass (OPCAB) surgery.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Angiomax Rtu

Condition Name

Condition Name for Angiomax Rtu
Intervention Trials
Coronary Artery Bypass Surgery 4
Coronary Artery Disease 3
Myocardial Infarction 2
Cardiovascular Disease 2
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Condition MeSH

Condition MeSH for Angiomax Rtu
Intervention Trials
Myocardial Ischemia 5
Coronary Artery Disease 5
Coronary Disease 4
Infarction 3
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Clinical Trial Locations for Angiomax Rtu

Trials by Country

Trials by Country for Angiomax Rtu
Location Trials
United States 43
Canada 3
France 2
Netherlands 2
Czech Republic 1
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Trials by US State

Trials by US State for Angiomax Rtu
Location Trials
New York 6
Ohio 6
North Carolina 3
California 3
Texas 2
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Clinical Trial Progress for Angiomax Rtu

Clinical Trial Phase

Clinical Trial Phase for Angiomax Rtu
Clinical Trial Phase Trials
Phase 4 4
Phase 3 10
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Angiomax Rtu
Clinical Trial Phase Trials
Completed 12
Terminated 3
Unknown status 3
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Clinical Trial Sponsors for Angiomax Rtu

Sponsor Name

Sponsor Name for Angiomax Rtu
Sponsor Trials
The Medicines Company 11
NYU Langone Health 2
University of Texas Southwestern Medical Center 1
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Sponsor Type

Sponsor Type for Angiomax Rtu
Sponsor Trials
Other 17
Industry 14
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Angiomax RTU: Clinical Trials, Market Analysis, and Projections

Introduction

Angiomax RTU, a ready-to-use formulation of the anticoagulant bivalirudin, has been a significant development in the field of cardiovascular medicine. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Approval and Indications

Angiomax RTU was approved by the FDA in July 2019 for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including those with heparin-induced thrombocytopenia and thrombosis syndrome[2][4].

Phase III Trials for PCI

The primary clinical trials that led to the approval of Angiomax RTU involved comparing its efficacy and safety to the reference listed drug (RLD) Angiomax. These trials demonstrated that Angiomax RTU has the same active ingredient, dosage regimen, and anticoagulant activity as the RLD, but in a more convenient ready-to-use form[2][5].

ENDOMAX Trial for Peripheral Endovascular Procedures

In addition to PCI, Angiomax has been evaluated in the ENDOMAX trial, a phase III clinical trial focused on patients undergoing peripheral endovascular interventions (PEI). This trial aimed to compare Angiomax with unfractionated heparin (UFH) in terms of major bleeding complications and other clinically significant outcomes. The trial was designed to enroll approximately 3,900 patients and assess endpoints such as bleeding, death, myocardial infarction, stroke, and amputation[3].

Market Analysis

Market Need and Competition

The anticoagulant market is highly competitive, with several drugs available for preventing clot formation during cardiovascular procedures. However, Angiomax RTU offers a unique advantage with its ready-to-use formulation, which simplifies the preparation process and reduces the risk of contamination compared to the lyophilized powder form of the RLD[2][5].

Target Market

The primary target market for Angiomax RTU includes hospitals and healthcare facilities performing PCI and other cardiovascular interventions. Given its indication for patients with heparin-induced thrombocytopenia and thrombosis syndrome, it also targets a niche but critical patient population.

Pricing and Cost-Effectiveness

While the exact pricing of Angiomax RTU is not publicly disclosed, its convenience and reduced preparation time can lead to cost savings in the healthcare setting. The ready-to-use formulation eliminates the need for reconstitution, which can reduce labor costs and minimize the risk of errors associated with manual preparation[2].

Market Projections

Growth Potential

The market for anticoagulants is expected to grow due to an increasing number of cardiovascular procedures and an aging population with higher risks of thrombotic events. Angiomax RTU is well-positioned to capture a significant share of this market due to its ease of use and established safety and efficacy profile.

Expansion into New Indications

The ongoing ENDOMAX trial and potential labeling expansion for peripheral endovascular procedures could further broaden the market for Angiomax RTU. Success in these trials could lead to increased adoption in new clinical settings, driving market growth[3].

Competitive Landscape

While Angiomax RTU faces competition from other anticoagulants, its unique formulation and established clinical benefits are likely to maintain its market position. Continuous innovation and potential new indications will be crucial in maintaining a competitive edge.

Key Clinical and Market Highlights

  • Convenience: Angiomax RTU is a premixed, ready-to-use solution, reducing preparation time and the risk of contamination[2][5].
  • Efficacy and Safety: It has the same active ingredient and dosage regimen as the RLD, with established safety and efficacy in PCI procedures[2][5].
  • Target Population: It is indicated for patients undergoing PCI, including those with heparin-induced thrombocytopenia and thrombosis syndrome[2][4].
  • Potential Expansion: Ongoing trials for peripheral endovascular procedures could expand its market reach[3].

Regulatory and Quality Aspects

  • FDA Approval: Approved under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, leveraging the safety and efficacy data of the RLD[2][4].
  • Quality Control: The product has undergone rigorous quality assessments, including in vitro and in vivo studies, to ensure equivalence to the RLD in terms of anticoagulant activity and safety[5].

Conclusion

Angiomax RTU represents a significant advancement in anticoagulant therapy, offering a convenient and safe option for patients undergoing PCI and potentially other cardiovascular procedures. With its established clinical benefits, ongoing trials for new indications, and strong market positioning, Angiomax RTU is poised for continued growth and adoption in the healthcare sector.

Key Takeaways

  • Clinical Efficacy: Angiomax RTU has demonstrated equivalent efficacy and safety to the RLD in PCI procedures.
  • Market Position: Its ready-to-use formulation provides a competitive advantage in the anticoagulant market.
  • Growth Potential: Ongoing trials and potential labeling expansions could further increase its market reach.
  • Regulatory Compliance: The drug has been approved under Section 505(b)(2) of the FDCA, ensuring rigorous quality and safety standards.

FAQs

What is Angiomax RTU used for?

Angiomax RTU is used as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including those with heparin-induced thrombocytopenia and thrombosis syndrome.

How does Angiomax RTU differ from the original Angiomax?

Angiomax RTU is a ready-to-use solution, whereas the original Angiomax is a lyophilized powder that requires reconstitution before use.

What are the key benefits of Angiomax RTU?

The key benefits include convenience, reduced risk of contamination, and equivalent safety and efficacy to the reference listed drug.

Is Angiomax RTU approved for use in peripheral endovascular procedures?

Currently, Angiomax RTU is not approved for peripheral endovascular procedures, but it is being evaluated in the ENDOMAX trial for this indication.

What is the dosage regimen for Angiomax RTU?

The recommended dosage regimen for Angiomax RTU is a bolus injection (0.75 mg/kg) followed by a continuous intravenous infusion (1.75 mg/kg/h) for the duration of the PCI procedure and up to 4 hours post-procedure.

Sources

  1. FDA Center for Drug Evaluation and Research - Angiomax RTU (bivalirudin) NDA 211215 Other Review(s)[1].
  2. FDA Center for Drug Evaluation and Research - Angiomax RTU (bivalirudin) Injection, 5 mg/mL Summary Review[2].
  3. EVToday - Phase-III Trial Begins to Evaluate Angiomax in Patients Undergoing Peripheral Endovascular Procedures[3].
  4. FDA Center for Drug Evaluation and Research - Angiomax RTU (bivalirudin) Approval Letter[4].
  5. FDA Center for Drug Evaluation and Research - Angiomax RTU (bivalirudin) Injection Product Quality Review[5].

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