CLINICAL TRIALS PROFILE FOR TICLOPIDINE HYDROCHLORIDE

All Clinical Trials for ticlopidine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00262054 ↗	Un-fractionated Heparin Versus Bivalirudin During Percutaneous Coronary Interventions (PCI) (ISAR-REACT-3)	Completed	Deutsches Herzzentrum Muenchen	Phase 4	2005-11-01	The purpose of this study is to determine whether bivalirudin given during PCI is associated with better outcomes compared to un-fractionated heparin.
NCT00069069 ↗	E-Selectin Nasal Instillation to Prevent Secondary Stroke	Withdrawn	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1	2003-10-01	This study will determine the maximum safe dose of the experimental drug E-selectin that can be given to stroke patients. E-selectin causes white blood cells called lymphocytes to change so that they prevent clots from forming in the vessels that supply blood to the brain. The drug has been shown to be effective in animal models of stroke. This study will look at the safety of using this experimental drug in nasal instillation form in patients who have had a stroke or transient ischemic attack (TIA). Patients 45 years of age or older who have had a recent stroke or TIA (30 to 120 days before entering the study) due to a clot forming in a vessel that supplies blood to the brain may be eligible for this study. They must be taking at least one medication to prevent clots, such as coumadin, aspirin, ticlopidine, or others. Candidates will be screened with a physical and neurological examination, blood and urine tests, electrocardiogram (EKG), echocardiogram (ultrasound test of the heart), and magnetic resonance imaging (MRI) of the brain. Participants will be randomly assigned to receive E-selectin at a dose level of 5, 15, or 50 micrograms or a placebo (nasal drops with no active ingredient). They will instill a small, carefully premeasured amount (one dose) of fluid in their nose every other day for 10 days (total of 5 doses). This course of treatment will be repeated two times at 3-week intervals. Patients will be followed at 1 month and 3 months with a neurologic examination and blood and urine tests. They will be contacted by phone, fax, or email in between these two visits.
NCT00133003 ↗	Abciximab, Clopidogrel and Percutaneous Coronary Intervention in Acute Coronary Syndrome (ISAR-REACT-2)	Completed	Technische Universität München	Phase 4	2003-03-01	The purpose of this study is to determine whether there is any additional benefit from abciximab administration during percutaneous coronary intervention in patients presenting with acute coronary syndromes after pre-treatment with 600mg of clopidogrel.
NCT00133003 ↗	Abciximab, Clopidogrel and Percutaneous Coronary Intervention in Acute Coronary Syndrome (ISAR-REACT-2)	Completed	Deutsches Herzzentrum Muenchen	Phase 4	2003-03-01	The purpose of this study is to determine whether there is any additional benefit from abciximab administration during percutaneous coronary intervention in patients presenting with acute coronary syndromes after pre-treatment with 600mg of clopidogrel.
NCT00004727 ↗	Antiplatelet Therapy to Prevent Stroke in African Americans	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 4	1969-12-31	The African-American Antiplatelet Stroke Prevention Study is designed to prevent recurrent strokes by administration of aspirin or ticlopidine. The study also provides community information on reducing risk of stroke and recognizing the symptoms of stroke. The study involves more than 50 participating hospitals located throughout the United States. Study medication is provided free of charge, and a transportation stipend is available for those in need.

Clinical Trial Conditions for ticlopidine hydrochloride

Condition Name

Condition Name for ticlopidine hydrochloride
Intervention	Trials
Coronary Artery Disease	12
Renal Artery Stenosis	2
Stable Angina	2
Peptic Ulcer	2

Condition MeSH

Condition MeSH for ticlopidine hydrochloride
Intervention	Trials
Coronary Disease	14
Coronary Artery Disease	14
Myocardial Ischemia	12
Ischemia	3

Clinical Trial Locations for ticlopidine hydrochloride

Trials by Country

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−

Trials by Country for ticlopidine hydrochloride
Location	Trials
United States	82
Japan	19
Italy	9
Germany	4
Australia	3

Trials by US State

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−

Trials by US State for ticlopidine hydrochloride
Location	Trials
New York	5
Michigan	4
California	4
Missouri	3
Mississippi	3

Clinical Trial Progress for ticlopidine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for ticlopidine hydrochloride
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ticlopidine hydrochloride
Clinical Trial Phase	Trials
Completed	30
Unknown status	5
Withdrawn	2

Clinical Trial Sponsors for ticlopidine hydrochloride

Sponsor Name

Sponsor Name for ticlopidine hydrochloride
Sponsor	Trials
Boston Scientific Corporation	4
Deutsches Herzzentrum Muenchen	3
Sanofi	3

Sponsor Type

Sponsor Type for ticlopidine hydrochloride
Sponsor	Trials
Other	33
Industry	13
NIH	2

Ticlopidine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Ticlopidine hydrochloride is an antiplatelet drug that has been studied extensively for its efficacy in preventing strokes and other vascular events. Here, we will delve into the key findings from clinical trials, analyze the current market situation, and provide projections for the future of ticlopidine hydrochloride.

Clinical Trials Overview

Ticlopidine Aspirin Stroke Study (TASS)

The TASS trial, conducted at 56 North American centers, compared the effects of ticlopidine hydrochloride (500 mg daily) with aspirin (1300 mg daily) in patients with recent transient or mild persistent focal cerebral or retinal ischemia. The study involved 3069 patients and showed that ticlopidine was somewhat more effective than aspirin in preventing strokes, with a 12% risk reduction for nonfatal stroke or death and a 21% risk reduction for fatal and nonfatal strokes[1][3][4].

Canadian American Ticlopidine Study (CATS)

The CATS trial compared ticlopidine with placebo in patients with recent thromboembolic stroke. It reported a 23% relative risk reduction in the primary outcome of stroke, myocardial infarction, or vascular death, favoring ticlopidine[3][4].

Aspirin and Ticlopidine for Prevention of Recurrent Stroke in Black Patients (AAASPS)

This trial compared ticlopidine (500 mg/day) with aspirin (650 mg/day) in African American patients with noncardioembolic ischemic stroke. Although the trial was halted due to futility analyses indicating a low likelihood of ticlopidine being significantly better than aspirin, it suggested that aspirin might be as effective or even more effective in this specific population[3].

Efficacy and Safety Profile

Efficacy

Ticlopidine has been shown to be effective in reducing the risk of stroke and other vascular events. In the TASS and CATS trials, ticlopidine demonstrated a significant reduction in the incidence of stroke and vascular death compared to aspirin and placebo, respectively[1][3][4].

Safety Profile

Despite its efficacy, ticlopidine is associated with several side effects, including diarrhea (20%), skin rash (14%), and severe but reversible neutropenia (less than 1%)[1][3][4]. These adverse effects are more frequent and severe compared to aspirin, which limits its use.

Market Analysis

Current Market Size and Trends

The global ticlopidine hydrochloride market has been valued and projected to expand at a certain CAGR from 2019 to 2025. The market analysis includes global and Chinese capacity, production, and production value, as well as cost and profit estimations[2].

Market Competition

The market competition for ticlopidine hydrochloride is analyzed by company and by country, including the USA, EU, Japan, and China. This analysis helps in understanding the market dynamics and the competitive landscape[2].

Supply and Consumption

The global and Chinese supply and consumption of ticlopidine hydrochloride are closely monitored, including import and export data. This information is crucial for understanding the market demand and supply chain[2].

Projections and Future Outlook

Market Forecast

The market forecast for ticlopidine hydrochloride from 2023 to 2028 includes projections on global and Chinese capacity, production, and production value. It also estimates the market share, supply, and consumption trends during this period[2].

Economic Impact

The macroeconomic environment, both globally and in China, is expected to influence the ticlopidine hydrochloride market. Understanding these economic trends is essential for predicting market growth and challenges[2].

Industry Development

The industry development section outlines the challenges and opportunities for ticlopidine hydrochloride. This includes market entry strategies, countermeasures for economic impact, and feasibility studies for new project investments[2].

Key Takeaways

• Efficacy: Ticlopidine hydrochloride is more effective than aspirin in preventing strokes and vascular events, as shown in several clinical trials.
• Safety Concerns: Despite its efficacy, ticlopidine is associated with significant side effects, including diarrhea, skin rash, and severe reversible neutropenia.
• Market Trends: The global ticlopidine hydrochloride market is projected to grow, but it faces competition and is influenced by macroeconomic factors.
• Future Outlook: The market forecast indicates continued growth, but the industry must address the challenges posed by side effects and economic conditions.

FAQs

What are the primary clinical trials that have evaluated ticlopidine hydrochloride?

The primary clinical trials include the Ticlopidine Aspirin Stroke Study (TASS), the Canadian American Ticlopidine Study (CATS), and the Aspirin and Ticlopidine for Prevention of Recurrent Stroke in Black Patients (AAASPS) trial.

What are the common side effects of ticlopidine hydrochloride?

Common side effects include diarrhea, skin rash, and severe but reversible neutropenia.

How does ticlopidine hydrochloride compare to aspirin in stroke prevention?

Ticlopidine hydrochloride has been shown to be more effective than aspirin in preventing strokes and vascular events, but it is associated with more severe side effects.

What is the current market size and growth projection for ticlopidine hydrochloride?

The global ticlopidine hydrochloride market is valued and projected to expand at a certain CAGR from 2019 to 2025, with detailed forecasts available for the period from 2023 to 2028.

What are the main challenges facing the ticlopidine hydrochloride market?

The main challenges include the drug's side effect profile, market competition, and macroeconomic factors influencing supply and demand.

Sources

1. Ticlopidine Aspirin Stroke Study: "A randomized trial comparing ticlopidine hydrochloride with aspirin in preventing stroke in high-risk patients." PubMed, 24 Aug 1989.
2. Ticlopidine Hydrochloride Market Report: "Ticlopidine Hydrochloride Market Size, Share, and Forecast." Prof Research.
3. Aspirin and Ticlopidine for Prevention of Recurrent Stroke in Black Patients: "Aspirin and Ticlopidine for Prevention of Recurrent Stroke in Black Patients." JAMA, 11 Jun 2003.
4. Secondary Prevention of Non-Cardioembolic Stroke: "Secondary prevention of non-cardioembolic stroke." European Journal of Cardiology Practice, 19 May 2014.