CLINICAL TRIALS PROFILE FOR ANGIOMAX

All Clinical Trials for ANGIOMAX

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.
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.
NCT00433966 ↗	Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction	Completed	Boston Scientific Corporation	Phase 3	2005-03-01	The primary objectives of the trial are: 1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing a primary angioplasty strategy. 2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™ stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.

Clinical Trial Conditions for ANGIOMAX

Condition Name

Condition Name for ANGIOMAX
Intervention	Trials
Coronary Artery Bypass Surgery	4
Coronary Artery Disease	3
Cardiovascular Disease	2
Thrombosis	2

Condition MeSH

Condition MeSH for ANGIOMAX
Intervention	Trials
Coronary Artery Disease	5
Myocardial Ischemia	5
Coronary Disease	4
Acute Coronary Syndrome	3

Clinical Trial Locations for ANGIOMAX

Trials by Country

Trials by Country for ANGIOMAX
Location	Trials
United States	43
Canada	3
France	2
Netherlands	2
Austria	1

Trials by US State

Trials by US State for ANGIOMAX
Location	Trials
New York	6
Ohio	6
North Carolina	3
California	3
Texas	2

Clinical Trial Progress for ANGIOMAX

Clinical Trial Phase

Clinical Trial Phase for ANGIOMAX
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	10
Phase 2	3

Clinical Trial Status

Clinical Trial Status for ANGIOMAX
Clinical Trial Phase	Trials
Completed	12
Terminated	3
Unknown status	3

Clinical Trial Sponsors for ANGIOMAX

Sponsor Name

Sponsor Name for ANGIOMAX
Sponsor	Trials
The Medicines Company	11
NYU Langone Health	2
GlaxoSmithKline	1

Sponsor Type

Sponsor Type for ANGIOMAX
Sponsor	Trials
Other	17
Industry	14

ANGIOMAX Market Analysis and Financial Projection

Last updated: April 30, 2026

Angiomax (bivalirudin): Clinical Trials Update, Market Analysis, and Projection

What is Angiomax and how is it positioned in the thrombin-inhibition market?

Angiomax is bivalirudin, a direct thrombin inhibitor used primarily in percutaneous coronary intervention (PCI) and in certain anticoagulation settings where rapid, predictable anticoagulation is required. The commercial core is tied to:

• Cardiology procedure volumes (especially PCI in acute coronary syndromes and elective workflows)
• Hospital formulary adoption and guideline alignment
• Competition from heparin-based strategies and other anticoagulants

Angiomax’s market dynamics are shaped more by protocol preference and hospital purchasing than by “new breakthrough” demand.

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What does the clinical trials pipeline show for Angiomax?

No new late-stage, pivotal clinical trial program is identifiable from the current open-source landscape at a level that changes Angiomax’s core indication strategy. The clinical activity that remains visible is typically:

• Post-authorization studies
• Subgroup analyses and real-world evidence
• Comparative evaluations in routine practice (often without a decisive label-expanding endpoint)

For investment and R&D planning, the key practical read-through is that Angiomax’s clinical development is in a mature phase: label stability is the default assumption and differentiation comes from usage protocols, safety handling, and cost-performance rather than from new registrational outcomes.

Clinical takeaway for trials: Angiomax’s future value is driven by how hospitals keep it in PCI pathways, not by a near-term likelihood of major new indications based on a current high-impact trial footprint.

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What market segments drive Angiomax demand?

Demand maps to procedure and care-pathway categories:

1. PCI in coronary disease

   • Primary driver of bivalirudin use
   • Strongly influenced by cath lab throughput and ACS vs elective mix

2. Peri-procedural anticoagulation protocols

   • Adoption depends on institutional standard orders and operator familiarity
   • Switching costs exist due to dosing workflows and monitoring conventions

3. Safety and bleeding management requirements

   • Hospitals select anticoagulants based on bleeding-risk stratification and reversal/management practices

This mix means Angiomax’s demand grows in line with:

• PCI procedure volumes
• Market share within preferred anticoagulation protocols

It also means Angiomax has structural headwinds when:

• Hospitals standardize on alternative anticoagulation regimens
• Cost pressure increases during procurement cycles

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How does competition affect Angiomax pricing power and share?

Angiomax competes against anticoagulant standards that vary by institution and geography, including:

• Unfractionated heparin
• Low-molecular-weight heparins
• Other direct thrombin inhibitors and factor-targeting agents depending on local guideline interpretation and formulary policy

In mature anticoagulant markets, share shifts often come from:

• Protocol changes following guideline updates
• Bleeding-risk comparisons
• Global tender cycles
• Contracting and bundled cath lab economics

Commercial takeaway: Angiomax’s upside is capped by the fact that most remaining decisions are formulary and protocol-level, which are slower to change than drug innovation-driven demand.

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Market outlook: What is the realistic projection framework for Angiomax?

A practical projection for a mature, cardiology anticoagulant should treat growth as a function of four variables:

1. PCI procedure growth (volume tailwind)
2. Bivalirudin penetration (share tailwind or drag)
3. Net price trend (contracting and tender pressure)
4. Safety and protocol switching behavior (incremental share churn)

Because Angiomax is not on a clearly identifiable label-expansion trajectory in the current visible pipeline, projections should be built around status-quo usage with moderate penetration shifts.

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Market projection: base-case, downside, and upside scenarios

The projection below is structured as a scenario model anchored to procedure-linked demand and procurement effects. Use these as planning bands for revenue and volume sensitivity.

Scenario	PCI volume trend	Penetration trend (Angiomax share)	Net price trend	Resulting revenue direction
Downside	Flat to low single-digit	Share declines	Price erosion accelerates	Low growth or contraction
Base case	Low single-digit	Stable-to-slight share erosion	Price stable to modest decline	Low single-digit growth
Upside	Low single-digit	Share improves modestly	Price erosion slows	Mid to high single-digit growth

Why bands matter: In anticoagulants, procurement cycles and protocol standardization can move revenue meaningfully without any change in clinical practice beyond a few formulary decisions.

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What do historical clinical outcomes imply for ongoing adoption?

Angiomax is widely used because it has predictable anticoagulant effects and a well-characterized safety handling profile within PCI workflows. In practical adoption terms, hospitals continue to use it when:

• The protocol expects rapid onset/offset
• Clinicians trust bleeding-risk tradeoffs in routine PCI pathways
• Order sets and cath lab workflows support bivalirudin as standard

When hospitals switch, it is usually due to:

• Bleeding management strategies evolving in favor of alternative regimens
• Competitive tendering and contracting economics
• Protocol consolidation around fewer agents

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Regulatory and lifecycle considerations

For business planning, Angiomax should be treated as a long-cycle lifecycle product:

• Label stability is the dominant expectation
• Growth depends on procurement and protocol retention
• Any future upside depends on incremental adoption rather than new blockbuster launches

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Actionable business implications for R&D and investment

1. R&D signal: Angiomax’s value proposition is operational and procedural. A new candidate must beat Angiomax on bleeding outcomes, workflow simplicity, and procurement economics to drive share gains.
2. Investment signal: The near-term investment thesis is mainly tied to market share retention and procedure-linked growth, not a probability-weighted bet on new indications.
3. Commercial diligence: Monitor PCI protocol adoption and tender outcomes as leading indicators of trajectory.

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Key Takeaways

• Angiomax (bivalirudin) is a mature PCI anticoagulant where demand is driven by procedure volumes and formulary/protocol retention rather than new late-stage clinical breakthroughs.
• The current clinical-trials posture is consistent with post-authorization and non-registrational activity, implying label stability.
• Revenue projection is best modeled as scenario bands based on PCI growth, Angiomax penetration, and net price trends driven by hospital contracting.
• Competitive pressure is structural in anticoagulants; Angiomax’s future growth depends on incremental share and tender economics, not transformative differentiation.

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FAQs

1. What is Angiomax used for clinically?
   It is used primarily as an anticoagulant in PCI and related procedural settings where direct thrombin inhibition is part of the protocol.

2. Is Angiomax expected to gain new major indications soon?
   The visible current clinical posture supports mature-phase activity without a clear near-term label-expanding registrational direction.

3. What drives Angiomax revenue most: price or volume?
   The dominant driver is typically procedure-linked volume, with net price shaped by hospital procurement and tender cycles.

4. What are the main competitive alternatives to Angiomax in hospitals?
   Hospitals often compare bivalirudin against heparin-based regimens and other anticoagulation strategies based on bleeding-risk protocols and contracting.

5. What is the most important KPI to track for Angiomax?
   PCI protocol penetration (share of cases where Angiomax is used) and its movement across formulary and tender cycles.

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References

[1] FDA Label for Angiomax (bivalirudin). U.S. Food and Drug Administration.
[2] Angiomax (bivalirudin) prescribing information and product monograph sources. Regulatory and manufacturer documentation.
[3] Clinical trial registry entries for bivalirudin/bivalirudin-related studies (where applicable). ClinicalTrials.gov.