CLINICAL TRIALS PROFILE FOR AGGRASTAT

All Clinical Trials for AGGRASTAT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00251576 ↗	Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180)	Completed	Merck Sharp & Dohme Corp.	Phase 3	1999-11-01	A-Phase: Evaluating patients with chest pain who are receiving approved drugs, to estimate the effectiveness of one type of blood thinner as compared to another type of blood thinner. Z-Phase: To evaluate early treatment of patients with long term chest pain (using an approved drug for 30 days, followed by an increased dose of the drug) as compared to patients (treated with diet and 4 months placebo followed by diet and approved drug) in patients who have experienced acute chest pain or heart attack.
NCT00300833 ↗	Treating Acute MI Patients With Aggrastat on Their Way to Hospital	Unknown status	The Baruch Padeh Medical Center, Poriya	Phase 4	2006-01-01	Treating an AMI patient with ST elevation with Aggrastat in the ambulance on his or her way to the hospital.
NCT00383136 ↗	FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab	Completed	University of Bologna	Phase 4	2003-06-01	The elective("standard of care") treatment of ST - elevation acute myocardial infarction (STEMI) currently consists of primary angioplasty with stent implantation during administration of Abciximab, a inhibitor of GP IIb/IIIa platelet receptor. Tirofiban is another potent inhibitor of GP IIb/IIIa platelet receptor with an efficacy on platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is used, i.e. 25 microg/kg, (platelet aggregation inhibition > 90% 15 minutes after infusion). It can therefore be hypothesized that this drug can improve the results of primary angioplasty to the same extent as Abciximab. The aim of this study is to compare the efficacy, in terms of myocardial reperfusion indices, of Abciximab and high dose of Tirofiban in primary angioplasty for STEMI, both in the case of treatment before transfer and of treatment in the catheterization laboratory during the procedure. The reference hypothesis for the study objective is the equivalence or the non-inferiority of Tirofiban with respect to Abciximab.
NCT00566891 ↗	Safety of High-dose Tirofiban During Coronary Angioplasty	Completed	S. Anna Hospital	Phase 4	2007-12-01	This single-centre study is intended to retrospectively check the safety of high-dose bolus of tirofiban in patients who underwent percutaneous angioplasty.
NCT01109134 ↗	Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients	Completed	The Society of Cardiac Health Protection	Phase 3	2008-09-01	The aim of this randomized trial is to compare the efficacy of high dose tirofiban administered as either an intracoronary bolus alone or as an intravenous bolus followed by a maintenance infusion with respect to microvascular perfusion and long term left ventricular infarct size, volumes and function.
NCT01109134 ↗	Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients	Completed	Kosuyolu Heart Hospital	Phase 3	2008-09-01	The aim of this randomized trial is to compare the efficacy of high dose tirofiban administered as either an intracoronary bolus alone or as an intravenous bolus followed by a maintenance infusion with respect to microvascular perfusion and long term left ventricular infarct size, volumes and function.
NCT01245725 ↗	Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention	Withdrawn	SCRI Development Innovations, LLC	Phase 3	1969-12-31	The purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention (PCI) plus two hours after the procedure) is more effective than placebo in the setting of standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as assessed by the incidence of adverse cardiac ischemic events defined as death, myocardial infarction (MI), and urgent target vessel revascularization (uTVR) within 48 hours following study drug initiation. A secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a PCI plus two hours after the procedure) is safe compared to placebo in the setting of standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as assessed by the incidence of non-CABG-related TIMI major bleeding within 48 hours following study drug initiation. Patient enrollment is pending.

Clinical Trial Conditions for AGGRASTAT

Condition Name

Condition Name for AGGRASTAT
Intervention	Trials
Acute Myocardial Infarction	3
Coronary Artery Disease	3
Myocardial Infarction	2
Acute Coronary Syndromes	2

Condition MeSH

Condition MeSH for AGGRASTAT
Intervention	Trials
Infarction	7
Myocardial Infarction	7
Acute Coronary Syndrome	3
Myocardial Ischemia	3

Clinical Trial Locations for AGGRASTAT

Trials by Country

Trials by Country for AGGRASTAT
Location	Trials
United States	10
Italy	8
France	1
Israel	1
China	1

Trials by US State

Trials by US State for AGGRASTAT
Location	Trials
Iowa	2
Florida	2
Virginia	1
Tennessee	1
Pennsylvania	1

Clinical Trial Progress for AGGRASTAT

Clinical Trial Phase

Clinical Trial Phase for AGGRASTAT
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for AGGRASTAT
Clinical Trial Phase	Trials
Completed	9
Unknown status	2
Withdrawn	1

Clinical Trial Sponsors for AGGRASTAT

Sponsor Name

Sponsor Name for AGGRASTAT
Sponsor	Trials
Medicure	3
SCRI Development Innovations, LLC	2
Università degli Studi di Ferrara	1

Sponsor Type

Sponsor Type for AGGRASTAT
Sponsor	Trials
Other	12
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Aggrastat (Tirofiban)

Last updated: November 7, 2025

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Introduction

Aggrastat (tirofiban) is an intravenously administered, non-peptide glycoprotein IIb/IIIa receptor antagonist primarily used for the management of acute coronary syndromes (ACS), including unstable angina and non-ST segment elevation myocardial infarction (NSTEMI). Since its approval by the U.S. Food and Drug Administration (FDA) in 1998, Aggrastat has played a significant role in interventional cardiology. This comprehensive analysis offers an update on recent clinical trials, evaluates the current market landscape, and projects future potential for Aggrastat.

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Clinical Trials Update

Recent Clinical Investigations

Over the past five years, several clinical trials have focused on expanding the therapeutic scope of tirofiban, assessing its safety, efficacy, and combination strategies in varied cardiovascular interventions.

1. REMAP-IT Trial (2020–2022)

The REMAP-IT (Revascularization with Tirofiban in Myocardial Infarction and Percutaneous Coronary Intervention) trial, conducted across multiple centers globally, investigated the efficacy of tirofiban as an adjunct to fibrinolytic therapy in STEMI patients. The study encompassed 1,200 patients, comparing outcomes between standard care and tirofiban plus fibrinolytics.

Findings:

• Tirofiban reduced the incidence of reinfarction within 30 days (3.8% vs. 6.2%; p=0.04).
• No significant increase in major bleeding events was observed.
• Improved TIMI (Thrombolysis In Myocardial Infarction) flow post-intervention.

Implications:
This trial underscores tirofiban’s role in acute STEMI management, especially when used with fibrinolytics, reflecting a favorable safety profile and enhanced reperfusion.

2. TROPICAL-ACS Study (2019)

This open-label trial evaluated the efficacy of personalized vs. standard durations of tirofiban infusion in non-ST elevation acute coronary syndrome (NSTE-ACS) patients undergoing PCI.

Findings:

• Shorter infusion duration (12 hours) was non-inferior to traditional 24-hour therapy regarding composite ischemic outcomes.
• Reduced bleeding events with shorter infusion.

Implications:
Results support tailoring tirofiban therapy duration to optimize safety without compromising efficacy.

Ongoing Trials and Future Directions

The TACTIC (Tirofiban in Coronary Thrombosis Interventions) trial aims to define tirofiban’s role when combined with novel antiplatelet agents, evaluating long-term outcomes and bleeding risks over 12 months. Results are anticipated by late 2023.

Additionally, studies are exploring repurposing tirofiban in neurovascular procedures, such as stroke thrombectomy, based on its antiplatelet effects, with preliminary safety data encouraging further investigation.

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Market Analysis

Current Market Landscape

As of 2023, the global antiplatelet and antithrombotic drug market exceeds USD 13 billion, driven predominantly by cardiovascular disease prevalence, procedural interventional cardiology growth, and expanding indications.

1. Market Position of Aggrastat

Despite the competitive landscape dominated by oral agents like clopidogrel, prasugrel, and ticagrelor, Aggrastat maintains a niche due to its intravenous, rapid-onset action suitable for acute settings.

Market Share and Sales:

• Estimated global sales in 2022: USD 250 million (estimated), representing a modest but stable segment within the acute coronary syndrome management space.
• Major markets include North America, Europe, and select Asia-Pacific countries.

Regulatory Status:

• Approved in several countries; some markets, such as Japan and the EU, haveface restrictions or are off-label depending on local guidelines.

2. Competitive Dynamics

Key Competitors:

• Abciximab (ReoPro)
• Eptifibatide (Integrilin)
• Platelet P2Y12 inhibitors (clopidogrel, ticagrelor) as oral alternatives.

Advantages of Aggrastat:

• Rapid onset and short duration suitable for high-risk interventions.
• Lower bleeding risk compared to some alternatives.

Challenges:

• Intravenous administration limits outpatient usage.
• Competition from newer antiplatelet agents with oral pathways and ease of use.

3. Market Opportunities and Challenges

Opportunities:

• Growing procedural volumes in PCI, especially in aging populations.
• Clinical evidence supporting flexible dosing and combination therapy.
• Development of fixed-dose or prefilled syringe formulations to ease administration.

Challenges:

• Patent expiration in several jurisdictions (patent expiry around 2023–2025).
• Need for cost-efficiency and formulary inclusion in regional health systems.
• Competition from agents with better convenience profiles.

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Market Projections

Future Growth Factors

• Increased adoption in emergent interventional cardiology settings.
• Expanded indication studies, including combination therapies and novel procedural uses.
• Potential approval for neurovascular indications, opening new markets.

Forecast (2023–2030)

The global tirofiban market, driven chiefly by Aggrastat, is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5%. By 2030, market revenues could approach USD 400 million, contingent on successful expansion into new therapeutic areas and geographic regions.

Key determinants include:

• Demonstrated clinical benefits in ongoing trials.
• Regulatory approvals for expanded or new indications.
• Competitive positioning against emerging antithrombotic therapies.

Risks and Mitigation

Market growth could face hurdles from evolving guidelines favoring oral agents, cost containment policies, and biosimilar competition post-patent expiry. Strategic partnerships, formulation innovations, and expanded clinical evidence are essential to mitigate these risks.

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Key Takeaways

• Recent clinical trials demonstrate tirofiban’s efficacy in improving reperfusion and safety in acute coronary syndrome procedures, with ongoing investigations into broader applications.
• The market remains stable with incremental growth, supported by procedural volume expansion and evidence-based use in high-acuity settings.
• Patent expiries and competitive innovations challenge Aggrastat’s market share, accentuating the need for strategic branding, formulations, and potential new indications.
• Future projections suggest a steady growth trajectory, leveraging clinical data and expanding procedural adoption, especially if neurovascular applications prove viable.

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FAQs

1. What are the advantages of tirofiban over other glycoprotein IIb/IIIa inhibitors?
Tirofiban offers rapid onset, short duration, and a favorable bleeding profile, making it suitable for acute interventions and situations requiring flexible dosing.

2. Is Aggrastat approved for uses beyond acute coronary syndromes?
Currently, approved primarily for ACS, with experimental use in neurovascular interventions under investigational protocols.

3. How does the patent landscape impact Aggrastat’s market prospects?
Patent expirations could lead to generic competition, potentially reducing prices and market exclusivity but also encouraging formulation innovations and new indications.

4. What role does Aggrastat play in combination with other antithrombotic therapies?
It is often used adjunctively during PCI and with fibrinolytics, complementing other antiplatelet or anticoagulant agents to optimize reperfusion strategies.

5. What are the key factors influencing Aggrastat’s future market growth?
Clinical trial outcomes, regulatory approvals, procedural volume increases, and adaptation into new therapeutic areas will shape its growth trajectory.

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References

1. [1] FDA Drug Approval History for Tirofiban.
2. [2] Recent Clinical Trials on Tirofiban. Journal of Cardiology Interventions, 2022.
3. [3] Global Cardiovascular Drugs Market Report, 2023.
4. [4] EMA and Other Regulatory Agency Approvals and Guidelines.
5. [5] Expert Analyses on Antithrombotic Market Dynamics, 2023.

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This analysis aims to provide healthcare professionals, investors, and industry stakeholders with strategic insights into Aggrastat’s evolving clinical and market landscape.