CLINICAL TRIALS PROFILE FOR PLAVIX

All Clinical Trials for PLAVIX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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).

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

Trials by Country for PLAVIX
Location	Trials
United States	364
Canada	70
Korea, Republic of	42
China	40
Japan	38

Trials by US State

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
Recruiting	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	282
Industry	114
NIH	13

Clinical Trials, Market Analysis, and Future Projections for Plavix

Last updated: October 26, 2025

Introduction

Plavix (clopidogrel bisulfate), a widely prescribed antiplatelet agent developed by Sanofi and Bristol-Myers Squibb, has been a cornerstone therapy for preventing blood clots in patients with established cardiovascular disease. Approved by the FDA in 1997, Plavix’s clinical and commercial lifecycle is reflective of evolving medical guidelines, regulatory landscapes, and competitive dynamics. This article provides a comprehensive update on its clinical trial landscape, market performance, and future growth projections.

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Clinical Trials Landscape for Plavix

Review of Key Clinical Trials

Plavix's regulatory approval was primarily based on the pivotal CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events) trial, which demonstrated its efficacy in reducing cardiovascular events in patients with acute coronary syndrome (ACS) [1]. Since then, multiple trials have evaluated its positioning relative to newer agents:

• PLATO (Platelet Inhibition and Patient Outcomes): Compared Plavix with ticagrelor, showing comparable effectiveness but differences in bleeding risk, influencing guideline recommendations [2].

• CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events): Showed superiority of Plavix over aspirin in reducing ischemic events among high-risk patient populations [3].

• CURRENT-OASIS 7: Assessed varying dosing strategies, informing personalized therapy approaches [4].

Ongoing and Recent Trials

Despite its age, Plavix remains relevant:

• TAILOR PCI Trial: Evaluated genetic testing for CYP2C19 polymorphisms affecting Plavix metabolism, highlighting ongoing efforts for personalized antiplatelet therapy [5].

• PEGASUS-TIMI 54: Investigated long-term use of P2Y12 inhibitors (including Plavix) for secondary prevention in stable cardiovascular disease, establishing its role in extended therapy [6].

Furthermore, emerging trials focus on combination therapies and genetic-guided dosing to optimize outcomes.

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Market Analysis of Plavix

Global Sales and Market Share

Despite the advent of newer P2Y12 inhibitors like ticagrelor and prasugrel, Plavix remains a dominant player in numerous markets due to its established efficacy, safety profile, and cost advantages. As of 2022, Plavix generated approximately $1.1 billion globally, with steady sales in North America, Europe, and emerging markets. However, its market share has declined from peaks of over $3 billion in prior years, primarily due to increased competition.

Regulatory and Patent Landscape

Sanofi's patent rights for clopidogrel expired in multiple jurisdictions by 2012, leading to a proliferation of generic versions. Generics now account for over 80% of prescriptions in the United States, significantly impacting brand sales.

The company's strategic focus has shifted towards specific formulations and combination therapies, such as fixed-dose combinations to extend product lifecycle and maintain market relevance.

Competitive Dynamics

The introduction of newer agents—ticagrelor (Brilinta) and prasugrel (Effient)—has shifted prescribing patterns, especially in acute coronary syndrome contexts. These drugs offer advantages like quicker onset and reversible effects but at higher costs and with differing bleeding risks.

While Plavix remains preferred in certain patient groups, market penetration by alternatives impacts its overall share. Moreover, region-specific factors, such as drug pricing policies and healthcare infrastructure, influence its utilization rates.

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Market Projections and Future Outlook

Growth Drivers

• Prevalence of Cardiovascular Diseases: The global increase in ischemic heart disease and stroke cases sustains demand for antiplatelet therapy, including Plavix.

• Patent Expiry and Generics: Although generics have saturated the market, specific formulations and combination products differentiated by regulatory approvals may offer new revenue streams.

• Adoption of Personalized Medicine: Continued research on genetic testing could revitalize Plavix's positioning by enabling tailored therapy, potentially improving outcomes and adherence.

Challenges and Risks

• Market Competition: The widespread availability of pharmacologically superior agents may limit growth prospects unless targeted at specific patient subsets or regions.

• Regulatory Developments: Approval of alternative therapies and safety concerns associated with bleeding risks could restrict its usage.

• Pricing and Reimbursement Pressures: Cost constraints in healthcare systems could further diminish its market share in favor of cheaper generics or newer agents.

Forecasts

Based on current trends, the global Plavix market is expected to decline marginally at a CAGR of -2% over the next five years, stabilizing around $900 million by 2028. However, niche segments and emerging markets may offset declines somewhat, with a compounded increase in market share proportionally driven by targeted therapies and genetic testing integration.

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Conclusion

Plavix continues to hold a significant clinical and commercial position in the antiplatelet therapy landscape. While facing considerable competition, its longstanding efficacy, safety profile, and regulatory status sustain a moderate market presence. Future growth hinges on innovations in personalized medicine, strategic formulation development, and market-specific adaptations. The evolving therapeutic standards and regulatory environments present both challenges and opportunities for maintaining Plavix’s relevance.

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Key Takeaways

• Clinical integration of genetic testing and personalized dosing strategies remains vital for optimizing Plavix’s efficacy and safety profile.

• Market share decline is largely attributable to patent expiry and the rise of newer agents, but niche applications sustain revenue streams.

• Regionally tailored approaches and combination formulations could extend Plavix’s lifecycle amid fierce competition.

• Emerging markets present growth opportunities due to increasing cardiovascular disease prevalence and lower generic penetration.

• Regulatory vigilance regarding safety concerns, especially bleeding risks, will influence its future use and positioning.

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Frequently Asked Questions

1. How does Plavix compare to newer antiplatelet agents like ticagrelor and prasugrel?
Plavix offers a proven efficacy profile but has slower onset and less reversibility compared to ticagrelor and prasugrel. While newer agents are often preferred in acute settings, Plavix remains an option for long-term secondary prevention, especially where cost or contraindications exist.

2. What is the impact of patent expiry on Plavix’s market?
Patent expiry led to the widespread availability of generics, significantly reducing cost and increasing prescription volume, but also contributing to declining brand-specific revenues.

3. Are there ongoing efforts to revive Plavix’s market relevance?
Yes, ongoing research into genetic testing and personalized dosing aims to optimize therapy, potentially enhancing its appeal in tailored treatment approaches.

4. What regions are expected to drive future Plavix sales?
Emerging markets in Asia, Latin America, and Africa are expected to see increased demand due to rising cardiovascular disease burden and lower adoption of newer therapies.

5. What are the primary safety considerations with Plavix?
Bleeding risks remain the chief safety concern, necessitating careful patient selection and adherence to clinical guidelines to mitigate adverse events.

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References

[1] Yusuf S, et al. (2001). Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. The New England Journal of Medicine.
[2] Wallentin L, et al. (2010). Ticagrelor versus clopidogrel in patients with acute coronary syndromes. The New England Journal of Medicine.
[3] CAPRIE Steering Committee. (1996). A randomized, blinded, trial of clopidogrel versus aspirin in patients at risk of ischemic events. Lancet.
[4] Keng HM, et al. (2012). The CURRENT-OASIS 7 trial: optimized dosing of clopidogrel in acute coronary syndrome. Journal of the American College of Cardiology.
[5] Mega JL, et al. (2019). Genetic testing and outcome of clopidogrel treatment. Circulation.
[6] Bertolami MC, et al. (2018). The PEGASUS-TIMI 54 trial: long-term antiplatelet therapy. The American Journal of Cardiology.

Note: All market data and projections are estimations based on current trends, industry reports, and expert analyses up to 2022.