ticagrelor for Coronary Artery Disease

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Sinai Center for Thrombosis Research, Baltimore, MD
Coronary Artery Disease+6 More
ticagrelor - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether ticagrelor therapy is associated with equivalent platelet inhibition irrespective of the disease status in patients undergoing PCI.

See full description

Eligible Conditions

  • Coronary Artery Disease
  • Stable Angina (SA)
  • Cardiovascular Disease (CVD)
  • Myocardial Infarction

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Coronary Artery Disease

Study Objectives

This trial is evaluating whether ticagrelor will improve 1 primary outcome in patients with Coronary Artery Disease. Measurement will happen over the course of Pre-LD dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study MD dose (14 +/- 3 days)..

Day 3
Inhibition of platelet aggregation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Coronary Artery Disease

Side Effects for

Aspirin + Ticagrelor
BARC 235
7%
Myocardial Infarction
3%
Stent Thrombosis, definite or probable
1%
Ischemic Stroke
0%
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT02270242) in the Aspirin + Ticagrelor ARM group. Side effects include: BARC 235 with 7%, Myocardial Infarction with 3%, Stent Thrombosis, definite or probable with 1%, Ischemic Stroke with 0%.

Trial Design

1 Treatment Group

Ticagrelor
1 of 1
Experimental Treatment

This trial requires 200 total participants across 1 different treatment group

This trial involves a single treatment. Ticagrelor is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Ticagrelor
Drug
As per ACC/AHA and ESC guidelines 180 mg is the recommended LD. The ticagrelor 90 mg BID dose, following the loading dose, has been selected for the clopidogrel naïve patients with stable angina, NSTEMI and STEMI patients undergoing PCI as the maintenance dose for this study since it is the FDA recommended dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ticagrelor
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-ld dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study md dose (14 +/- 3 days).
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly pre-ld dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study md dose (14 +/- 3 days). for reporting.

Who is running the study

Principal Investigator
P. A. G.
Paul A. Gurbel, Director
LifeBridge Health

Closest Location

Sinai Center for Thrombosis Research - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Stable Angina: Stable coronary artery disease patients with documented ischemia undergoing elective PCI will be enrolled.Inclusion criteria for enrollment in the ACS group with or without ST-segment elevation, requires onset of symptoms during the previous 48 hours.
NSTEMI
a positive test of a biomarker (troponin I) in accordance with the universal definitions indicating myocardial necrosis
ST-segment changes on electrocardiography, indicating ischemia that do not meet criteria for STEMI.
STEMI
either persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block;
the intention to perform primary PCI with 24 hours of symptom onset

Patient Q&A Section

How many people get coronary artery disease a year in the United States?

"Approximately 39.4 million American adults had CAD by January 2010. This accounts for 24.2% of the population. There are substantial regional differences in the burden of CAD, which is predicted to increase significantly in the future because of projected changes in prevalence of risk factors, advances in diagnostics, and enhanced treatment options." - Anonymous Online Contributor

Unverified Answer

What causes coronary artery disease?

"The underlying cause of angina and myocardial infarction (heart attack) is coronary artery disease (CAD). It is caused by atherosclerosis of the coronary arteries where blood vessels grow too narrow or hardened, forming fatty deposits on the inner surface of the arteries. Other risk factors include high blood pressure and lifestyle patterns such as smoking, excess alcohol and excessive salt in the diet.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of coronary artery disease?

"Individuals with no symptoms of coronary artery disease do not need medical tests for coronary artery disease diagnosis: they can get a diagnosis clinically. Many tests of cardiac markers such as creatine kinase and troponin do not detect the early stage of coronary artery disease and may not be helpful unless there are clinical symptoms or risk factors. A screening medical test for coronary artery disease should not be done in patients who are asymptomatic. Clinicians should focus on people who have heart attacks and chest pain and risk factors for coronary artery disease such as high blood pressure, diabetes, and smoking. Clinicians can get a diagnosis clinically for patients with chest pain who do not have risk factors for coronary artery disease and who do not have clinical heart symptoms." - Anonymous Online Contributor

Unverified Answer

Can coronary artery disease be cured?

"Currently PCI is the only treatment option to help people with severe coronary artery disease and is effective, but costly. In many countries, PCI has become the standard treatment for people with stable angina. As a result, there is growing pressure on hospitals to perform PCI too soon. This is because by doing so, coronary artery disease and subsequent heart attacks can be prevented for nearly 10 years. Data from a recent study, doctors could not find any reliable evidence of a cure for coronary artery disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for coronary artery disease?

"The treatment for coronary artery disease is highly symptomatic, but also highly dependent on each patient and their specific circumstances. As with treatment for other heart diseases, prevention has the greatest influence. The key to prevention is limiting coronary risk factors (smoking, hypertension, diabetes, dyslipidemia) as much as possible." - Anonymous Online Contributor

Unverified Answer

What is coronary artery disease?

"Coronary artery disease (i.e. coronary heart disease) is the leading cause of death among those under the age of 45 in the United States (27.5% of the population). It is manifested through heart attacks (i.e. myocardial infarction) or angina and can sometimes lead to sudden cardiac death. Another complication that can arise from coronary artery disease is chronic heart failure." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of coronary artery disease?

"We conclude that the primary causes of coronary artery disease are high blood pressure, dyslipidemia, diabetes mellitus, and cigarette smoking. These conditions are easily controlled at primary care settings by appropriately prescribing medications and healthy meals and exercising regularly to maintain a healthy weight." - Anonymous Online Contributor

Unverified Answer

What is the latest research for coronary artery disease?

"Cardiac disease continues to be an important topic in the news. Cardiac disease is currently the leading cause of death in men and women in the U.S., and will be even more important, as the heart ages. Current research efforts are focusing on prevention, early diagnosis, and development of innovative therapeutics. The U.S. [National Heart, Lung, and Blood Institute’s (NHLBI) “Cardiovascular Health Profile”]. [www.cdc.gov/nchs/bcp.htm] lists many of the latest scientific findings for [coronary artery disease] (CAD) of all ages, and can help you begin designing your own cardiac disease plan." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets coronary artery disease?

"There are fewer men than women who have CAD and people have CAD throughout their lives. However, the average age at diagnosis for CAD is similar for men and women in early to mid-adulthood." - Anonymous Online Contributor

Unverified Answer

Is ticagrelor typically used in combination with any other treatments?

"As of September 2013, ticagrelor is not included as a concomitant treatment in any commercially available dual antiplatelet drugs, although some other agents are available." - Anonymous Online Contributor

Unverified Answer

Is ticagrelor safe for people?

"The findings do not support the safety or efficacy of ticagrelor in a primary PCI setting as for people without aspirin intolerance or contraindications. Additional studies are needed." - Anonymous Online Contributor

Unverified Answer

What is ticagrelor?

"[Ticagrelor is a medication which is used to treat cardiovascular disease as a secondary prevention of heart attacks and strokes. Ticagrelor reduces the risk of heart attacks or strokes by 12%." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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