CLINICAL TRIALS PROFILE FOR AMINOCAPROIC

All Clinical Trials for Aminocaproic

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00156520 ↗	Platelet Function And Aggregometry In Patients With Aortic Valve Stenosis	Completed	University of Rochester	Phase 4	2005-03-01	It is known that patients with aortic stenosis, including those undergoing cardiac surgery for this problem, are prone to developing bleeding problems, particularly of the gastrointestinal tract. It is believed that the shear stress associated with blood flow through the abnormal aortic valve results in abnormal hemostasis. Abnormalities include increased proteolysis of the von Willebrand factor (vWF) and increased binding of the high molecular weight multimers of vWF to platelet membranes with subsequent inappropriate platelet aggregation. Thus, appropriate aggregation of circulating platelets is impaired. Cardiac surgery is associated with significant alterations in hemostasis. Patients undergoing cardiac surgery consume a significant percent of available blood products throughout the United States and are subjected to various and numerous risks associated with blood product transfusion. In addition, excessive postoperative bleeding is a common cause for the need to surgically re-explore the chest cavity in patients who have just undergone cardiac surgical procedures. Such additional surgery carries further cost and risk. Following surgical correction of aortic valve stenotic pathology, associated vWF abnormalities appear to reverse. However, this process can take several days. Although all cardiac surgical patients are at risk for postoperative bleeding, patients undergoing aortic valve surgery for aortic stenosis may be particularly at risk for this postoperative complication. In addition, patients with aortic valve stenosis who undergo noncardiac surgery may have a predisposition to bleeding because of similar underlying shear stress induced abnormal vWF and platelet function. The proposed study is a trial to evaluate the effectiveness of 2 different antifibrinolytic drugs in ameliorating the hemostatic defect associated with aortic stenosis. Aprotonin, an antifibrinolytic agent which also has platelet preserving actions4, will be compared to the currently used anti-fibrinolytic, epsilon aminocaproic acid (EACA).
NCT00223704 ↗	Bradykinin Receptor Antagonism During Cardiopulmonary Bypass	Completed	Vanderbilt University	Phase 2/Phase 3	2006-05-01	Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00223704 ↗	Bradykinin Receptor Antagonism During Cardiopulmonary Bypass	Completed	Vanderbilt University Medical Center	Phase 2/Phase 3	2006-05-01	Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00320619 ↗	Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	2000-09-01	Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.

Clinical Trial Conditions for Aminocaproic

Condition Name

Condition Name for Aminocaproic
Intervention	Trials
Bleeding	3
Blood Loss	3
Blood Loss, Surgical	3
Craniosynostosis	2

Condition MeSH

Condition MeSH for Aminocaproic
Intervention	Trials
Hemorrhage	16
Osteoarthritis	3
Blood Loss, Surgical	3
Scoliosis	2

Clinical Trial Locations for Aminocaproic

Trials by Country

Trials by Country for Aminocaproic
Location	Trials
United States	40
Egypt	4
Canada	2
Brazil	2
Mexico	2

Trials by US State

Trials by US State for Aminocaproic
Location	Trials
New York	5
Illinois	3
Georgia	3
North Carolina	3
California	3

Clinical Trial Progress for Aminocaproic

Clinical Trial Phase

Clinical Trial Phase for Aminocaproic
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Aminocaproic
Clinical Trial Phase	Trials
Completed	25
Unknown status	4
Recruiting	3

Clinical Trial Sponsors for Aminocaproic

Sponsor Name

Sponsor Name for Aminocaproic
Sponsor	Trials
Duke University	2
Texas Children's Hospital	2
Emory University	2

Sponsor Type

Sponsor Type for Aminocaproic
Sponsor	Trials
Other	51
NIH	2
Industry	2

Aminocaproic Acid: Clinical Trials, Market Analysis, and Projections

Overview of Aminocaproic Acid

Aminocaproic acid, marketed under the brand name Amicar, is an antifibrinolytic agent used to induce clotting and prevent excessive bleeding. It works by inhibiting plasminogen activators and, to a lesser degree, by antiplasmin activity, thereby reducing fibrinolysis and promoting clot stability[1].

Clinical Trials Update

Aminocaproic acid has been through various phases of clinical trials to assess its efficacy and safety.

• Phase 0, 1, 2, 3, and 4 Trials: As of the latest data, aminocaproic acid has been involved in multiple clinical trials across different phases. There have been 2 Phase 0 trials, 5 Phase 1 trials, 5 Phase 2 trials, 2 Phase 3 trials, and 9 Phase 4 trials. These trials have focused on its use in various conditions, including postoperative bleeding, hemophilia, and heavy menstrual bleeding[1].

• Current Status: The ongoing and completed trials have provided valuable insights into the drug's safety profile and therapeutic efficacy. For instance, trials have shown that aminocaproic acid is effective in reducing bleeding in surgical patients and those with bleeding disorders, although it must be used cautiously to avoid adverse effects such as thrombogenic activities when combined with certain other drugs[1][4].

Market Analysis

The market for antifibrinolytic drugs, including aminocaproic acid, is experiencing significant growth driven by several factors.

Market Size and Growth

• Global Market Value: The global antifibrinolytic drugs market was valued at $13,593 million in 2018 and is projected to reach $19,333 million by 2026, growing at a CAGR of 4.5%[2].
• Projected Growth: By 2029, the global antifibrinolytic market is expected to reach $22.16 billion, growing at a CAGR of 5% from 2021[3].

End Users and Distribution Channels

• Hospitals and Clinics: The hospitals and clinics segment dominated the market in 2018 and is expected to maintain its dominance. This is due to the high frequency of surgeries, such as cardiovascular and neurosurgeries, performed in these settings[2].
• Trauma Centers: The trauma centers segment is anticipated to grow at the fastest rate due to the increasing number of road accidents globally, particularly in regions like Africa and Asia-Pacific[2][3].

Regional Market

• North America: This region held a major share of the antifibrinolytic drugs market in 2018 and is expected to continue this trend. The high adoption rate of these drugs, especially among women to control heavy menstrual flow, and the significant number of surgeries performed in this region contribute to its market dominance[2].
• Asia-Pacific: This region is expected to grow at the fastest rate during the forecast period, driven by the surge in road accidents and the increasing awareness and adoption of antifibrinolytic drugs in countries like India and China[2][3].

Market Drivers and Restraints

Drivers

• Increasing Road Accidents: The substantial increase in road accidents globally, especially in low- and middle-income economies, is a major driver for the growth of the antifibrinolytic drugs market[2][3].
• Growing Demand in Gynecology: The rising adoption of antifibrinolytic drugs to prevent heavy menstrual flow and other gynecologic syndromes is another significant driver[3].
• Surge in Medical Surgeries: The increasing number of surgeries, including cardiovascular and neurosurgeries, also contributes to the market growth[2].

Restraints

• High Cost and Reimbursement Issues: The high cost of antifibrinolytic drugs and stringent reimbursement scenarios are expected to hamper market growth[2].
• Adverse Effects and Interactions: The potential for adverse effects and drug interactions, such as increased thrombogenic activities when combined with certain drugs, is another restraint[1][4].

Production and Supply Update

Despite the recent closure of Akorn Pharmaceuticals, one of the manufacturers of aminocaproic acid, there is no anticipated shortage of the drug. Other manufacturers have assured the FDA that they can meet market demands for both tablet and oral solution formulations of aminocaproic acid[5].

Key Takeaways

• Clinical Trials: Aminocaproic acid has been extensively tested in various clinical trials, demonstrating its efficacy in preventing excessive bleeding.
• Market Growth: The global antifibrinolytic drugs market, including aminocaproic acid, is projected to grow significantly due to increasing road accidents, growing demand in gynecology, and the surge in medical surgeries.
• Regional Dominance: North America currently dominates the market, but the Asia-Pacific region is expected to grow at the fastest rate.
• Production Stability: Despite manufacturing disruptions, the supply of aminocaproic acid is expected to remain stable.

FAQs

What is the primary use of aminocaproic acid?

Aminocaproic acid is primarily used as an antifibrinolytic agent to induce clotting and prevent excessive bleeding, particularly postoperatively and in patients with bleeding disorders[1].

What are the potential adverse effects of aminocaproic acid?

Aminocaproic acid can cause adverse effects such as transient hypotension and severe acute renal failure. It also interacts with other drugs, increasing the risk of thrombogenic activities[1][4].

How is the global antifibrinolytic drugs market expected to grow?

The global antifibrinolytic drugs market is expected to grow at a CAGR of 4.5% from 2018 to 2026 and reach $22.16 billion by 2029, growing at a CAGR of 5% from 2021[2][3].

Which regions are expected to drive the growth of the antifibrinolytic drugs market?

North America currently dominates the market, but the Asia-Pacific region is expected to grow at the fastest rate due to the surge in road accidents and increasing awareness and adoption of antifibrinolytic drugs[2][3].

Is there a risk of aminocaproic acid shortage due to manufacturing disruptions?

Despite the closure of Akorn Pharmaceuticals, other manufacturers have assured the FDA that they can meet market demands, and no shortage of aminocaproic acid is anticipated[5].

Sources

1. DrugBank: Aminocaproic acid: Uses, Interactions, Mechanism of Action.
2. Allied Market Research: Antifibrinolytic Drugs Market Size, Share and Trends | Analysis by ...
3. Data Bridge Market Research: Global Antifibrinolytic Market – Industry Trends and Forecast to 2029.
4. Molina Healthcare: Hemostatic Agents C14570-A.
5. NBDF: Aminocaproic Acid Production Update.