CLINICAL TRIALS PROFILE FOR PLAVIX

All Clinical Trials for PLAVIX

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).
NCT00140465 ↗	75 or 150 mg Clopidogrel Maintenance Doses Following PCI (ISAR-CHOICE-2)	Completed	Technische Universität München	Phase 4	2004-10-01	The purpose of the study is to test whether an increase of the maintenance dose of clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced platelet aggregation
NCT00140465 ↗	75 or 150 mg Clopidogrel Maintenance Doses Following PCI (ISAR-CHOICE-2)	Completed	Deutsches Herzzentrum Muenchen	Phase 4	2004-10-01	The purpose of the study is to test whether an increase of the maintenance dose of clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced platelet aggregation
NCT00153062 ↗	PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes	Completed	Bayer	Phase 4	2003-08-01	The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.
NCT00153062 ↗	PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes	Completed	GlaxoSmithKline	Phase 4	2003-08-01	The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.
NCT00153062 ↗	PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes	Completed	Boehringer Ingelheim	Phase 4	2003-08-01	The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.
NCT00050817 ↗	Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA)	Completed	Sanofi	Phase 3	2002-10-01	RATIONALE: - Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death. - In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients. - The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis. OBJECTIVES: - To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in preventing cardiovascular morbidity/mortality. The study will compare the efficacy of the two regimens in preventing the occurrence of major cardiovascular complications (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise receiving low-dose aspirin therapy (75-162 mg daily). - To evaluate the safety of clopidogrel in this population, and more specifically the incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate the global benefit of clopidogrel in this patient population.

Clinical Trial Conditions for PLAVIX

Condition Name

Condition Name for PLAVIX
Intervention	Trials
Coronary Artery Disease	48
Acute Coronary Syndrome	29
Healthy	13
Myocardial Infarction	12

Condition MeSH

Condition MeSH for PLAVIX
Intervention	Trials
Coronary Artery Disease	61
Coronary Disease	56
Myocardial Ischemia	53
Acute Coronary Syndrome	38

Clinical Trial Locations for PLAVIX

Trials by Country

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Trials by Country for PLAVIX
Location	Trials
United States	363
Canada	70
Korea, Republic of	42
China	40
Japan	38

Trials by US State

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−

Trials by US State for PLAVIX
Location	Trials
Florida	23
Ohio	18
Texas	18
New York	17
Pennsylvania	16

Clinical Trial Progress for PLAVIX

Clinical Trial Phase

Clinical Trial Phase for PLAVIX
Clinical Trial Phase	Trials
Phase 4	103
Phase 3	35
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for PLAVIX
Clinical Trial Phase	Trials
Completed	127
Unknown status	36
Terminated	19

Clinical Trial Sponsors for PLAVIX

Sponsor Name

Sponsor Name for PLAVIX
Sponsor	Trials
AstraZeneca	15
University of Florida	9
Bristol-Myers Squibb	8

Sponsor Type

Sponsor Type for PLAVIX
Sponsor	Trials
Other	281
Industry	114
NIH	11

Clinical Trials, Market Analysis, and Projections for Plavix (Clopidogrel)

Introduction

Plavix, also known as clopidogrel, is a widely used antiplatelet medication that has been a cornerstone in the prevention of cardiovascular events. Here, we will delve into recent clinical trial updates, market analysis, and projections for this drug.

Recent Clinical Trials: STOPDAPT-2 and DAPT Trials

STOPDAPT-2 Trial

The STOPDAPT-2 trial has provided significant insights into the long-term use of clopidogrel. This trial involved 3,005 patients undergoing percutaneous coronary intervention (PCI) with a cobalt-chromium everolimus-eluting stent. Patients were randomized to either a shortened dual antiplatelet therapy (DAPT) strategy with aspirin plus clopidogrel or prasugrel for 1 month, followed by clopidogrel monotherapy for 11 months, or standard DAPT for 12 months. At 5 years, the trial showed that clopidogrel monotherapy was associated with a 23% lower risk of major cardiovascular outcomes compared to aspirin alone[1].

DAPT Trial

The DAPT trial compared dual antiplatelet therapy with clopidogrel or prasugrel plus aspirin for 12 months versus 30 months in patients with drug-eluting coronary stents. The results indicated that extended DAPT reduced heart attacks and stent thrombosis but increased the risk of death, primarily from non-cardiovascular causes such as cancer or trauma. However, the FDA review found no overall increase in cancer-related adverse events with long-term clopidogrel use, although there was a noted increase in cancer-related deaths in the 30-month arm compared to the 12-month arm[3].

Market Analysis

Market Size and Growth

The clopidogrel market is experiencing robust growth, driven by several key factors. The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 9.10% from 2024 to 2031. This growth is largely attributed to the increasing prevalence of cardiovascular diseases, an aging global population, and improvements in healthcare and diagnosis[2].

Driving Factors

• Growing Prevalence of Cardiovascular Diseases: Conditions such as peripheral artery disease, coronary artery disease, and stroke are driving the demand for clopidogrel.
• Aging Population: The incidence of cardiovascular illnesses rises with age, supporting the need for antiplatelet therapy.
• Improvements in Healthcare and Diagnosis: Early identification of cardiovascular diseases due to enhanced diagnostic equipment and healthcare systems increases the requirement for clopidogrel.
• Growing Awareness and Preventive Healthcare: Rising awareness of cardiovascular disease risks and the importance of preventive treatment also contribute to the demand.
• Increased Healthcare Access: Expanding healthcare infrastructure in developing nations is making clopidogrel more accessible[2].

Market Projections

Geographic Trends

The clopidogrel market is dynamic and varies by region:

• Asia Pacific: Rapid growth driven by increasing patient populations, rising disposable incomes, and expanding healthcare facilities.
• Latin America: Mixed landscape with growth potential in urban centers but challenges in rural areas.
• Middle East and Africa: Showing potential growth driven by increasing healthcare investment and rising disease awareness, though hindered by disparities in healthcare infrastructure[2].

Competitive Landscape

The market is influenced by several factors, including:

• Patent Expiration and Generic Competition: The expiration of clopidogrel’s patents has led to the entry of generic versions, increasing competition and reducing costs.
• Technological Advances: Novel approaches to medication formulation and delivery could enhance the convenience and efficacy of clopidogrel therapy.
• Regulatory Approvals and Guidelines: Changes in clinical guidelines and regulatory approvals can impact how clopidogrel is integrated into treatment plans[2].

Challenges and Opportunities

Challenges

• Adverse Effects and Safety Concerns: Reports of bleeding hazards and drug interactions may restrict the use of clopidogrel or lead to its replacement by newer medications with higher safety profiles.
• Regulatory and Approval Obstacles: The need for lengthy clinical trials to prove the safety and efficacy of new formulations or indications can be a significant barrier.
• Market Saturation: The presence of alternative antiplatelet medications may limit the expansion potential of clopidogrel[2].

Opportunities

• Growing Demand in Emerging Markets: Increasing healthcare access and awareness in developing nations present opportunities for market growth.
• Innovations in Medication Formulation: Improvements in drug delivery and formulation can enhance patient compliance and treatment outcomes.
• Expanding Indications: Research into new indications for clopidogrel, such as its use in mild ischemic stroke or transient ischemic attack (TIA), can further expand its market[2][4].

Key Takeaways

• Clinical Trials: Recent trials like STOPDAPT-2 and DAPT have shown that clopidogrel monotherapy can be effective in reducing cardiovascular outcomes, although long-term use requires careful consideration of risks and benefits.
• Market Growth: The clopidogrel market is expected to grow significantly due to increasing prevalence of cardiovascular diseases, an aging population, and improvements in healthcare.
• Geographic Trends: The market is dynamic, with different regions presenting unique opportunities and challenges.
• Challenges and Opportunities: While safety concerns and regulatory hurdles exist, there are also opportunities for growth through innovations and expanding indications.

FAQs

Q: What are the key findings of the STOPDAPT-2 trial regarding clopidogrel use?

A: The STOPDAPT-2 trial found that clopidogrel monotherapy after a shortened DAPT period was associated with a 23% lower risk of major cardiovascular outcomes at 5 years compared to aspirin alone[1].

Q: How does the DAPT trial impact the understanding of long-term clopidogrel use?

A: The DAPT trial showed that extended DAPT with clopidogrel reduced heart attacks and stent thrombosis but increased non-cardiovascular deaths. However, it did not find an overall increase in cancer-related adverse events with long-term clopidogrel use[3].

Q: What are the main drivers of the growing clopidogrel market?

A: The main drivers include the increasing prevalence of cardiovascular diseases, an aging global population, improvements in healthcare and diagnosis, growing awareness of preventive healthcare, and increased healthcare access in developing nations[2].

Q: How does the expiration of clopidogrel’s patents affect the market?

A: The expiration of patents has led to the entry of generic versions, increasing competition, reducing costs, and expanding accessibility to the medication[2].

Q: What are some potential challenges facing the clopidogrel market?

A: Challenges include adverse effects and safety concerns, regulatory and approval obstacles, and market saturation due to alternative medications[2].

Sources

1. TCTMD: Five Years Post-PCI, Clopidogrel Monotherapy Holds Up in STOPDAPT-2.
2. Verified Market Research: Clopidogrel Market Size, Share, Scope, Trends, Growth & Forecast.
3. FDA: FDA review finds long-term treatment with blood-thinning medicine.
4. JAMA Network: Clopidogrel and Aspirin Initiated Between 24 to 72 Hours for Mild Ischemic Stroke or TIA.