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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR EPTIFIBATIDE


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All Clinical Trials for Eptifibatide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00061373 ↗ Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial (CATALIST) Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2003-05-01 Ischemic stroke is caused by a blood clot that blocks the flow of blood to the brain and damages brain cells. The clot, or thrombus, is made up of platelets and fibrin. The medicine alteplase, also known as tPA , is the standard drug used to treat patients with acute ischemic stroke. tPA attacks the fibrin portion of the blood clot. While intravenous (iv) tPA alone is effective in treating the fibrin part of the clot approximately 30% of the time, adding other commercially available drugs such eptifibatide to treat other clot components may improve the effectiveness of iv tPA therapy. This is a clinical trial to determine an acceptable dose of eptifibatide in combination with aspirin, the low molecular weight heparin tinzaparin, and standard iv tPA therapy for the treatment of acute ischemic stroke. Use of clinical and imaging based selection criteria are hypothesized to contribute to treatment safety by selecting patients at lower risk of intracerebral hemorrhage. Also,selection and evaluation of patients by magnetic resonance imaging (MRI) criteria will result in a different risk to benefit ratio than selecting patients without MRI criteria and will lead to a different acceptable dose.
NCT00089895 ↗ EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED) Completed Duke Clinical Research Institute Phase 3 2004-11-01 The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).
NCT00089895 ↗ EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2004-11-01 The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).
NCT00111566 ↗ BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention Completed University of British Columbia Phase 4 2004-12-01 This trial was designed to examine the efficacy of a brief versus a standard prolonged (18 hours) infusion of eptifibatide in preventing troponin I release following successful coronary stenting.
NCT00111566 ↗ BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention Completed Cardiology Research UBC Phase 4 2004-12-01 This trial was designed to examine the efficacy of a brief versus a standard prolonged (18 hours) infusion of eptifibatide in preventing troponin I release following successful coronary stenting.
NCT00250991 ↗ Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 1/Phase 2 2003-07-01 The purpose of this study is determine the effects of using of a combination of two drugs--integrilin (eptifibatide) and activase (recombinant tissue plasminogen activator, rt-PA, or recombinant t-PA)--to dissolve blood clots in patients who have a stroke.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Eptifibatide

Condition Name

Condition Name for Eptifibatide
Intervention Trials
Acute Coronary Syndrome 6
Myocardial Infarction 5
Coronary Artery Disease 3
Acute Ischemic Stroke 3
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Condition MeSH

Condition MeSH for Eptifibatide
Intervention Trials
Infarction 14
Myocardial Infarction 13
Acute Coronary Syndrome 8
Ischemic Stroke 7
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Clinical Trial Locations for Eptifibatide

Trials by Country

Trials by Country for Eptifibatide
Location Trials
United States 108
Germany 9
Italy 7
Canada 4
Poland 4
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Trials by US State

Trials by US State for Eptifibatide
Location Trials
Ohio 7
New York 6
Pennsylvania 5
Michigan 5
Kentucky 5
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Clinical Trial Progress for Eptifibatide

Clinical Trial Phase

Clinical Trial Phase for Eptifibatide
Clinical Trial Phase Trials
Phase 4 11
Phase 3 9
Phase 2 12
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Clinical Trial Status

Clinical Trial Status for Eptifibatide
Clinical Trial Phase Trials
Completed 22
Terminated 6
Unknown status 4
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Clinical Trial Sponsors for Eptifibatide

Sponsor Name

Sponsor Name for Eptifibatide
Sponsor Trials
National Institute of Neurological Disorders and Stroke (NINDS) 5
Schering-Plough 3
University of Cincinnati 3
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Sponsor Type

Sponsor Type for Eptifibatide
Sponsor Trials
Other 41
Industry 12
NIH 5
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Eptifibatide: Clinical Trials, Market Analysis, and Projections

Introduction to Eptifibatide

Eptifibatide, marketed under the brand name Integrilin, is a potent platelet aggregation inhibitor used primarily in the management of acute coronary syndromes (ACS) and as an adjunctive therapy during percutaneous coronary intervention (PCI). Here, we will delve into the clinical trials, market analysis, and projections for this crucial cardiovascular medication.

Clinical Trials and Efficacy

ESPRIT Trial

One of the pivotal clinical trials that established the efficacy of eptifibatide is the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. This randomized, double-blind, placebo-controlled trial involved 2064 patients undergoing nonurgent coronary stent implantation. The trial demonstrated that eptifibatide significantly reduced the composite rates of death or myocardial infarction (MI) and death, MI, or target vessel revascularization at 48 hours and 30 days, with these benefits persisting up to 6 months[1].

Key Findings

  • By 6 months, the composite end point of death or MI occurred in 7.5% of eptifibatide-treated patients versus 11.5% in the placebo group.
  • The composite of death, MI, or target vessel revascularization was 14.2% in eptifibatide-treated patients compared to 18.3% in the placebo group.
  • The treatment effect was most pronounced in the early phase (<48 hours) but was maintained through 6 months[1].

Recent Trials

In November 2023, Merck announced positive results from a Phase III trial evaluating eptifibatide in patients with acute coronary syndrome who are at high risk of bleeding. This trial further solidified eptifibatide's role in managing ACS, particularly in high-risk patients[2].

Market Analysis

Global Market Size and Growth

The global eptifibatide market is projected to grow at a compound annual growth rate (CAGR) of 5% from 2023 to 2030. In 2023, the market was valued at approximately USD 389.82 million and is expected to reach USD 577.29 million by 2030[5].

Regional Market Dynamics

  • North America: This region commands the largest market share, driven by a high prevalence of cardiovascular diseases and a well-established healthcare infrastructure. North America is expected to continue its dominance, with a robust market size projected by 2030[2].
  • Asia Pacific: This region is the fastest-growing hub, driven by an increasing incidence of cardiovascular diseases, a burgeoning population, and rising healthcare investments. The market size in this region is anticipated to reach significant levels by 2030[2].

Market Drivers

  • Rising Incidence of Cardiovascular Diseases: The growing prevalence of conditions such as myocardial infarction and unstable angina drives the demand for eptifibatide.
  • Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure and the adoption of advanced technologies enhance the diagnosis and management of cardiovascular conditions, further boosting the market for eptifibatide[2][3].
  • Regulatory Approvals: Recent regulatory approvals, such as the coverage announcement by the Centers for Medicare and Medicaid Services (CMS) in July 2023, also contribute to market growth[2].

Market Segmentation

The eptifibatide market is segmented based on type (eptifibatide injection, eptifibatide powder) and application (acute coronary syndrome treatment, percutaneous coronary intervention). The fastest-growing application category is unstable angina, reflecting evolving treatment protocols and the drug's proven efficacy in this area[2][3].

Market Projections

Future Growth

The eptifibatide market is expected to expand significantly due to several factors:

  • Continuous Clinical Research: Ongoing clinical trials investigating new indications and combination therapies will drive market growth.
  • Geographic Expansion: Strategic focus on expanding into emerging markets with growing healthcare infrastructure will unlock additional value.
  • Innovative Formulations: Improvements in medication formulations and administration methods will enhance patient compliance and treatment outcomes[2][3][5].

Key Statistics

  • Base Year (2023): USD 389.82 million
  • Estimated Year (2024): USD 411.06 million
  • Forecast Year (2030): USD 577.29 million
  • CAGR: 5.76%[5].

Regulatory and Coverage Updates

CMS Coverage

In July 2023, the Centers for Medicare and Medicaid Services (CMS) announced coverage for eptifibatide for the treatment of ACS in patients undergoing PCI, which is expected to further boost market demand[2].

Conclusion

Eptifibatide remains a crucial medication in the management of acute coronary syndromes and during PCI procedures. The ESPRIT trial and other clinical studies have solidified its efficacy, while market projections indicate steady growth driven by rising cardiovascular disease incidence, advancements in healthcare, and ongoing clinical research.

Key Takeaways

  • Eptifibatide significantly reduces the risk of death, MI, and target vessel revascularization in patients undergoing PCI.
  • The global eptifibatide market is projected to grow at a CAGR of 5% from 2023 to 2030.
  • North America and the Asia Pacific region are key drivers of market growth.
  • Regulatory approvals and continuous clinical research support market expansion.

FAQs

What is the primary use of eptifibatide in clinical practice?

Eptifibatide is primarily used as an adjunctive therapy during percutaneous coronary intervention (PCI) and in the management of acute coronary syndromes (ACS).

What were the key findings of the ESPRIT trial?

The ESPRIT trial showed that eptifibatide reduced the composite rates of death or myocardial infarction and death, MI, or target vessel revascularization at 48 hours and 30 days, with benefits persisting up to 6 months.

Which regions are driving the growth of the eptifibatide market?

North America and the Asia Pacific region are the primary drivers of the eptifibatide market, due to a high prevalence of cardiovascular diseases and advancements in healthcare infrastructure.

What is the projected CAGR for the global eptifibatide market from 2023 to 2030?

The global eptifibatide market is projected to grow at a CAGR of 5% from 2023 to 2030.

What recent regulatory update has impacted the eptifibatide market?

In July 2023, the Centers for Medicare and Medicaid Services (CMS) announced coverage for eptifibatide for the treatment of ACS in patients undergoing PCI.

Sources

  1. JAMA Network: Platelet Glycoprotein IIb/IIIa Integrin Blockade With Eptifibatide in Coronary Stenting.
  2. Cognitive Market Research: Eptifibatide Market Report 2024 (Global Edition).
  3. Market Research Intellect: Eptifibatide Market Size and Projections.
  4. American Heart Association Journals: Management of Patients With Acute Coronary Syndromes.
  5. 360iResearch: Eptifibatide Market by Type (0.75mg/ml Eptifibatide, 2mg/ml Eptifibatide).

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