CLINICAL TRIALS PROFILE FOR BRILINTA

All Clinical Trials for BRILINTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01587651 ↗	Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease	Completed	Eli Lilly and Company	Phase 4	2012-03-01	This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized, 3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have previously received ticagrelor loading does (LD) and maintenance dose (MD)..
NCT01587651 ↗	Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease	Completed	Daiichi Sankyo Inc.	Phase 4	2012-03-01	This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized, 3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have previously received ticagrelor loading does (LD) and maintenance dose (MD)..
NCT01587651 ↗	Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease	Completed	Daiichi Sankyo, Inc.	Phase 4	2012-03-01	This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized, 3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have previously received ticagrelor loading does (LD) and maintenance dose (MD)..
NCT01373411 ↗	Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery	Completed	University of British Columbia	Phase 4	2011-09-01	Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48 hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which time they will receive telephone follow-up one and nine months following CABG and clinic visits three, six, and twelve months following CABG.
NCT01373411 ↗	Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery	Completed	Cardiology Research UBC	Phase 4	2011-09-01	Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48 hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which time they will receive telephone follow-up one and nine months following CABG and clinic visits three, six, and twelve months following CABG.

Clinical Trial Conditions for BRILINTA

Condition Name

Condition Name for BRILINTA
Intervention	Trials
Coronary Artery Disease	33
Acute Coronary Syndrome	16
Myocardial Infarction	9
Thrombosis	4

Condition MeSH

Condition MeSH for BRILINTA
Intervention	Trials
Coronary Artery Disease	37
Coronary Disease	34
Myocardial Ischemia	32
Acute Coronary Syndrome	19

Clinical Trial Locations for BRILINTA

Trials by Country

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Trials by Country for BRILINTA
Location	Trials
United States	121
China	26
Canada	15
Korea, Republic of	7
United Kingdom	4

Trials by US State

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Trials by US State for BRILINTA
Location	Trials
Florida	20
New York	8
Texas	8
Ohio	7
Minnesota	5

Clinical Trial Progress for BRILINTA

Clinical Trial Phase

Clinical Trial Phase for BRILINTA
Clinical Trial Phase	Trials
Phase 4	53
Phase 3	8
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for BRILINTA
Clinical Trial Phase	Trials
Completed	44
Unknown status	16
Withdrawn	9

Clinical Trial Sponsors for BRILINTA

Sponsor Name

Sponsor Name for BRILINTA
Sponsor	Trials
AstraZeneca	27
University of Florida	15
The First Affiliated Hospital with Nanjing Medical University	3

Sponsor Type

Sponsor Type for BRILINTA
Sponsor	Trials
Other	105
Industry	43
NIH	2

Clinical Trials, Market Analysis, and Projections for Brilinta (Ticagrelor)

Introduction to Brilinta (Ticagrelor)

Brilinta, known generically as ticagrelor, is a potent antiplatelet medication developed by AstraZeneca. It is used to prevent blood clots in patients with acute coronary syndrome (ACS) and those who have had a heart attack or stroke.

Clinical Trials: Key Findings

THALES Trial

The THALES trial was a significant Phase III study that evaluated the efficacy of Brilinta in patients who had experienced a minor acute ischemic stroke or high-risk transient ischemic attack (TIA). Here are the key findings:

• Primary Endpoint: Brilinta, when used in combination with aspirin, significantly reduced the risk of the composite endpoint of stroke and death compared to aspirin alone over a 30-day period[1].
• Patient Population: The trial involved over 11,000 patients who were randomized within 24 hours of the onset of symptoms and followed up for 30 days[1].
• Safety Profile: While Brilinta showed an increased bleeding rate, the overall safety profile was consistent with its known profile[1].
• Clinical Impact: The trial highlighted that the risk of subsequent stroke is highest in the first few days and weeks after a minor acute ischemic stroke or high-risk TIA, and Brilinta reduced this risk during this critical period[1].

PLATO and PEGASUS Trials

Other notable trials include the PLATO and PEGASUS studies:

• PLATO Trial: This trial compared Brilinta with clopidogrel in patients with ACS. Brilinta significantly reduced cardiovascular death, myocardial infarction, and stroke at 12 months compared to clopidogrel[4].
• PEGASUS Trial: This trial evaluated Brilinta in patients with a history of myocardial infarction. Brilinta, when added to aspirin, reduced the risk of cardiovascular death, myocardial infarction, and stroke compared to aspirin alone[4].

Market Analysis

Current Market Size and Growth

The global Brilinta market has shown robust growth driven by increasing demand for antiplatelet medications.

• Global Market Size: As of 2021, the Brilinta market was valued at approximately USD 1.523 billion and is projected to grow to USD 3.034 billion by 2029, with a CAGR of 9%[5].
• Regional Dominance: North America is expected to remain the largest market for Brilinta during the forecast period, followed by Europe. The Asia-Pacific region is anticipated to be the fastest-growing market due to increasing per capita disposable incomes and government initiatives to improve healthcare[5].

Market Drivers

Several factors are driving the growth of the Brilinta market:

• Increasing Cardiovascular Diseases: The rising incidence of heart attacks and strokes globally is a significant driver. According to the WHO, approximately 17 million people die each year due to cardiovascular disorders[5].
• Advancements in Healthcare: Availability of advanced treatment facilities, rising healthcare expenditure, and good healthcare infrastructure are also contributing to market growth[5].
• Demographic Factors: The increasing elderly population, which is highly susceptible to chronic diseases, is another key factor[5].

Competitive Landscape

AstraZeneca is the primary manufacturer of Brilinta, and the company has been focusing on expanding its market reach.

• Collaborations: AstraZeneca has collaborated with companies like Sun Pharmaceutical Industries Ltd. to distribute Brilinta in regions like India, enhancing its availability and usage[3].
• Market Projections: The global ticagrelor market, including Brilinta, is expected to reach USD 3.32 billion by 2032, growing at a CAGR of 6.40% during the forecast period 2023-2032[3].

Market Projections

Forecasted Market Size

The Brilinta market is expected to continue its growth trajectory driven by several factors:

• Global Forecast: The market is projected to grow significantly across various regions, with North America and Europe maintaining their dominance. The Asia-Pacific region is expected to be the fastest-growing market[2][5].
• Segment Analysis: The market is segmented by dosage (90 mg and 60 mg) and route of administration (oral and nasogastric tube). These segments are expected to contribute to the overall growth of the market[5].

Emerging Trends and Opportunities

Several trends and opportunities are expected to shape the future of the Brilinta market:

• Technological Innovations: Emerging technological innovations and the increasing adoption of digital technologies in healthcare are expected to open up new opportunities[2].
• Expanding Market Reach: Strategic collaborations and investments in innovative solutions will help companies capitalize on future growth prospects[2].
• Growing Demand in Emerging Markets: Regions like North America, Asia-Pacific, and Europe are expected to drive the growth due to evolving consumer preferences and increasing industrialization[2].

Key Takeaways

• Clinical Efficacy: Brilinta has demonstrated significant clinical efficacy in reducing the risk of stroke and death in patients with acute ischemic stroke or TIA, as well as in those with ACS and a history of myocardial infarction.
• Market Growth: The global Brilinta market is expected to grow substantially, driven by increasing demand for antiplatelet medications and advancements in healthcare.
• Regional Dominance: North America and Europe will continue to be major markets, with the Asia-Pacific region showing the fastest growth.
• Competitive Landscape: AstraZeneca remains the leading manufacturer, with strategic collaborations enhancing market reach.

FAQs

What is Brilinta used for?

Brilinta (ticagrelor) is used to prevent blood clots in patients with acute coronary syndrome (ACS) and those who have had a heart attack or stroke.

What were the key findings of the THALES trial?

The THALES trial showed that Brilinta, when used with aspirin, significantly reduced the risk of stroke and death in patients with minor acute ischemic stroke or high-risk TIA over a 30-day period.

What is the current market size of Brilinta?

As of 2021, the Brilinta market was valued at approximately USD 1.523 billion.

Which regions are expected to drive the growth of the Brilinta market?

North America and Europe are expected to remain the largest markets, with the Asia-Pacific region showing the fastest growth.

What are the main drivers of the Brilinta market growth?

The main drivers include the increasing incidence of cardiovascular diseases, advancements in healthcare, rising healthcare expenditure, and an aging population.

Who is the primary manufacturer of Brilinta?

AstraZeneca is the primary manufacturer of Brilinta.

Sources

1. AstraZeneca Press Release: "Brilinta met primary endpoint in Phase III THALES trial in stroke" - January 27, 2020.
2. News Channel Nebraska: "Brilinta Market Size and Growth Analysis by Manufactures, Emerging Trends and Forecast to 2032" - December 13, 2024.
3. Market Research Future: "Global Ticagrelor Market Projected To Grow Radiantly By 2032".
4. BRILINTA HCP: "PLATO & PEGASUS Primary Efficacy | BRILINTA | For HCPs".
5. Maximize Market Research: "Brilinta Market - Global Industry Analysis and forecast (2022-2029)".