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.

Clinical Trial Conditions for aggrastat

Condition Name

Condition Name for aggrastat
Intervention	Trials
Acute Myocardial Infarction	3
Coronary Artery Disease	3
Acute Coronary Syndromes	2
Unstable Angina	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

Aggrastat Market Analysis and Financial Projection

Aggrastat: Clinical Trials, Market Analysis, and Projections

Introduction

Aggrastat, also known as tirofiban hydrochloride, is a non-peptide antagonist of the platelet glycoprotein (GP) IIb/IIIa receptor, used to prevent thrombotic cardiovascular events in patients undergoing percutaneous coronary intervention (PCI) or those with acute coronary syndromes (ACS). Here, we delve into the recent clinical trials, market analysis, and projections for this critical antiplatelet medication.

Clinical Trials Update

SAVI-PCI Trial

One of the significant recent clinical trials involving Aggrastat is the Shortened Aggrastat versus Integrilin in Percutaneous Coronary Intervention (SAVI-PCI) trial. This U.S.-based, multicenter, randomized, open-label, non-inferiority trial compared the outcomes of patients treated with a short infusion of Aggrastat versus those treated with longer infusions of Aggrastat or Integrilin (eptifibatide)[1][4].

The trial demonstrated that the short infusion regimen of Aggrastat was non-inferior to the longer infusion regimens in terms of combined efficacy and major bleeding. Specifically, there was no substantial difference in major bleeding events between the short infusion Aggrastat group and the Integrilin group, while a significant decline was noted compared to the long infusion Aggrastat group[1].

PRISM and PRISM-PLUS Trials

Earlier large-scale clinical studies, such as the PRISM (Platelet Receptor Inhibition for Ischemic Syndrome Management) and PRISM-PLUS trials, established the efficacy of Aggrastat in treating patients with non-ST elevation acute coronary syndromes (NSTE-ACS). These trials showed a 32% risk reduction in the composite endpoint of death, new myocardial infarction, and refractory ischemia within 7 days when Aggrastat was used in combination with heparin compared to heparin alone[3][4].

Efficacy and Safety Profile

Efficacy

Aggrastat has been proven effective in reducing the rate of thrombotic cardiovascular events. In the PRISM-PLUS trial, the drug demonstrated a significant reduction in the composite endpoint of death, new myocardial infarction, and refractory ischemia. Specifically, there was a 47% reduction in myocardial infarction and a 30% reduction in refractory ischemia compared to heparin alone[4].

Safety

The safety profile of Aggrastat includes a risk of major and minor bleeding. The PRISM-PLUS study showed that the incidence of major bleeding was 1.4% in the Aggrastat plus heparin group, compared to 0.8% in the heparin alone group. However, the SAVI-PCI trial indicated that the short infusion regimen of Aggrastat did not significantly increase the risk of major bleeding compared to longer infusion regimens or Integrilin[1][3].

Market Analysis

Market Share and Competition

Aggrastat has maintained a significant presence in the market for GP IIb/IIIa inhibitors. Despite initial skepticism about its efficacy, Medicure has successfully increased its market share by explaining the correct High Dose Bolus (HDB) dosing and value proposition to interventional cardiologists and pharmacy managers. Partnerships with Key Opinion Leaders have also driven this change. As of recent reports, Aggrastat is used in over 1,200 US hospitals[2].

Sales and Revenue

The sales and revenue of Aggrastat have shown mixed trends. In Q3 2022, there was a 14% decrease in unit demand compared to Q2 2022 and a 21% decrease compared to Q3 2021. However, the net revenue increased by 6% compared to both Q2 2022 and Q3 2021, attributed to lower returns and improved contracting[2].

Market Projections

Antiplatelet Drug Market

The antiplatelet drug market, which includes Aggrastat, is subject to various trends and projections. While the overall sales of anti-platelet aggregation drugs have seen fluctuations, newer anticoagulants like rivaroxaban, ticagrelor, and apixaban have shown significant growth rates, often exceeding 40% annually. However, Aggrastat's established position and ongoing clinical evidence support its continued relevance in the market[5].

Strategic Approach

Medicure's strategic approach to maintaining brand dominance includes leveraging support from Key Opinion Leaders, account support, and ensuring the correct use of Aggrastat through educational initiatives. This approach has helped in overcoming initial skepticism and driving market share growth[2].

Key Takeaways

• Clinical Efficacy: Aggrastat has demonstrated efficacy in reducing thrombotic cardiovascular events in clinical trials such as SAVI-PCI, PRISM, and PRISM-PLUS.
• Safety Profile: The drug has a manageable safety profile with a risk of major and minor bleeding, but recent trials show no significant increase in bleeding with short infusion regimens.
• Market Presence: Aggrastat is widely used in over 1,200 US hospitals and has gained market share through strategic educational and partnership initiatives.
• Revenue Trends: Despite fluctuations in unit demand, net revenue has seen improvements due to better contracting and lower returns.
• Market Projections: The antiplatelet drug market is dynamic, but Aggrastat's established position and ongoing clinical evidence support its continued market relevance.

FAQs

What is Aggrastat used for?

Aggrastat is used to reduce the rate of thrombotic cardiovascular events in patients undergoing percutaneous coronary intervention (PCI) or those with acute coronary syndromes (ACS).

What were the findings of the SAVI-PCI trial?

The SAVI-PCI trial demonstrated that the short infusion regimen of Aggrastat was non-inferior to longer infusion regimens in terms of combined efficacy and major bleeding.

How does Aggrastat compare to other GP IIb/IIIa inhibitors?

Aggrastat has maintained a significant market share among GP IIb/IIIa inhibitors, with its use supported by clinical evidence and strategic market initiatives.

What are the safety concerns associated with Aggrastat?

The primary safety concern is the risk of major and minor bleeding, although recent trials indicate no significant increase in bleeding with short infusion regimens.

How has Aggrastat's market share evolved?

Aggrastat's market share has increased through educational initiatives, partnerships with Key Opinion Leaders, and correct dosing explanations to healthcare professionals.

Sources

1. Medicure's Aggrastat meets primary goal in coronary intervention trial - Clinical Trials Arena
2. Medicure Inc. - Investor Presentation - Medicure
3. AGGRASTAT® (tirofiban hydrochloride) injection, for intravenous use - FDA
4. Efficacy - Aggrastat HDB - Aggrastat HDB
5. Recent progress and market analysis of anticoagulant drugs - AME Groups