TQJ230 for Cardiovascular Disease and Lipoprotein(a)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novartis Investigative Site, Zwolle, Netherlands
Cardiovascular Disease and Lipoprotein(a)+1 More
TQJ230 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help reduce the risk of heart disease in patients with high levels of a certain protein.

See full description

Eligible Conditions

  • Cardiovascular Disease and Lipoprotein(a)

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Cardiovascular Disease and Lipoprotein(a)

Study Objectives

This trial is evaluating whether TQJ230 will improve 2 primary outcomes and 3 secondary outcomes in patients with Cardiovascular Disease and Lipoprotein(a). Measurement will happen over the course of approximately 4 years.

approximately 4 years
Number of participants with confirmed all-cause death
Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) ≥ 70 mg/dL
Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) ≥ 90 mg/dL.
Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization
Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke)

Trial Safety

Safety Progress

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

Other trials for Cardiovascular Disease and Lipoprotein(a)

Trial Design

2 Treatment Groups

TQJ230
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 8323 total participants across 2 different treatment groups

This trial involves 2 different treatments. TQJ230 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

TQJ230
Drug
TQJ230 80 mg injected monthly administered subcutaneously
Placebo
Drug
Monthly subcutaneous injections.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 4 years for reporting.

Closest Location

Novartis Investigative Site - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Key Inclusion Criteria
Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
Clinically significant symptomatic peripheral artery disease
Key

Patient Q&A Section

Can cardiovascular diseases be cured?

"Current research and evidence do not support the notion that cardiovascular diseases can be cured. With appropriate treatment, however, it is possible to diminish or stop the course of the diseases, but with very low rates of cure." - Anonymous Online Contributor

Unverified Answer

What are the signs of cardiovascular diseases?

"The data obtained point to an urgent need for campaigns aiming to warn citizens of the cardiovascular disease. The high percentage of smokers of the sample, the overconsumption of alcohol and coffee and the inadequate physical activity are also serious points of need for the creation of future strategies of the public health." - Anonymous Online Contributor

Unverified Answer

What is cardiovascular diseases?

"The common CVDs were CVDs, including atherosclerosis and atherosclerotic syndrome, coronary heart disease, arrhythmia, cerebrovascular disease, hypertension, and chronic kidney disease. The CVDs may cause morbidity, physical, psychological, and economic burden to society. Furthermore, CVDs are the predominant cause of mortality on both national and international level. Prevention and intervention are necessary to reduce these diseases and associated morbidity and mortality." - Anonymous Online Contributor

Unverified Answer

What causes cardiovascular diseases?

"The primary causes of cardiovascular diseases are: a) physical inactivity; b) increased body weight; c) diabetes mellitus and obesity d) tobacco use; e) chronic infections; f) chronic stress; and g) environmental factors." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cardiovascular diseases?

"There is not a single treatment of choice for CVDs. Treatment focuses on prevention and primary prevention, where effective treatments are often first-line therapies. New and more advanced medical therapies are being studied. Some treatments have significant side effects, so caution must be taken when prescribing or prescribing medications for these treatments." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving tqj230?

"There have been no other trials to test tqj230 in CHF or atrial fibrillation, and therefore it is not clear whether or not tqj230 can be safely administered for these uses. There is no compelling evidence to support a recommendation for or against treatment for tqj230 for CHF or atrial fibrillation. A larger study is required." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cardiovascular diseases?

"In last decade, there was a boom in the use of vascular surgical procedures. It is also evident that the mortality rate was quite high for such procedures." - Anonymous Online Contributor

Unverified Answer

How serious can cardiovascular diseases be?

"For some of them, it can be extremely serious. In addition, for others, the severity is often not known. Data from a recent study in this paper could be useful for clinicians who wish to discuss the severity of CV diseases with patients at a consultation." - Anonymous Online Contributor

Unverified Answer

Does cardiovascular diseases run in families?

"Even if there were differences in CV susceptibility at younger ages, which does not appear to be the case in Denmark, they disappeared when age was regarded as a covariate in multivariable models. Furthermore, we found a stronger contribution from the familial component in women, when age was regarded as a covariate. This indicates that familial factors are more important for CV diseases in females, and that they are less relevant in men." - Anonymous Online Contributor

Unverified Answer

Is tqj230 typically used in combination with any other treatments?

"There is no evidence that tqj230 is more effective when given in combination with other treatments as a maintenance treatment vs. monotherapy. In this cohort, tqj230 was more effective as maintenance therapy than as an add-on treatment in adults with IBS." - 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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