The SPIRE Program is looking for participants for a Clinical Trial involving High Cholesterol and other issues that may contribute to heart disease. If you are already on medication for
High Cholesterol, yet you continue to have issues with it still being high, this clinical trial and research study may be a good fit for you.
This study evaluates the PCSK9 inhibitor, Bococizumab compared to
placebo, in reducing the occurrence of major cardiovascular events,
including cardiovascular death, myocardial infarction, stroke, and
unstable angina requiring urgent revascularization, in high risk
subjects who are receiving background lipid lowering therapy and have
cholesterol laboratory values of LDL-C >/= 70 mg/dL or non-HDL-C
>/= 100 mg /dl
To learn more about this research project and find out if you qualify to participate see:
The full study details and eligibility criteria are listed
here.
From there you can fill out an online questionnaire below to see if you are eligible for the trial.
Please complete the online questionnaire to check if you’re eligible for the trial.
You may have questions about participating in a clinical trial and how this will work, Here is a bit of information in regard to clinical trials themselves.
I am including more information below in regard to what clinical trials are about and how they can help you and others as below:
GENERAL INFORMATION
What is a clinical trial?
A clinical trial (also called clinical research) is a research study in human volunteers to answer
specific health questions. Carefully conducted clinical trials are the fastest and safest way to
find treatments that work in people and ways to improve health. Interventional trials determine
whether experimental treatments or new ways of using known therapies are safe and effective
under controlled environments. Observational trials address health issues in large groups of
people or populations in natural settings.
What are the benefits and risks of participating in a
clinical trial?
Clinical trials that are well designed and well executed are the best approach for participants
to:
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● Play an active role in their own health care.
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● Gain access to new research treatments before they are widely available.
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● Help others by contributing to medical research.
There are also risks to clinical trials:
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● There may be unpleasant, serious or even life threatening side effects to treatment.
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● The treatment may not be effective for the participant.
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● The protocol may require more of their time and attention than would a nonprotocol
treatment, including trips to the study site, more treatments, hospital stays or complex
dosage requirements
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In
addition, most clinical research is federally regulated with built in safeguards to protect the
participants. The trial follows a carefully controlled protocol, a study plan which details what
researchers will do in the study. As a clinical trial progresses, researchers report the results of
the trial at scientific meetings, to medical journals, and to various government agencies.
Individual participants’ names will remain secret and will not be mentioned in these reports
(See Confidentiality Regarding Trial Participants).
PARTICIPATION
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access
to new research treatments before they are widely available, and help others by contributing
to medical research.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria
is an important principle of medical research that helps to produce reliable results. The factors
that allow someone to participate in a clinical trial are called “inclusion criteria” and those that
disallow someone from participating are called “exclusion criteria”. These criteria are based
on such factors as age, gender, the type and stage of a disease, previous treatment history,
and other medical conditions. Before joining a clinical trial, a participant must qualify for the
study. Some research studies seek participants with illnesses or conditions to be studied in
the clinical trial, while others need healthy participants. It is important to note that inclusion
and exclusion criteria are not used to reject people personally. Instead, the criteria are used to
identify appropriate participants and keep them safe. The criteria help ensure that researchers
will be able to answer the questions they plan to study.
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****BELOW IS MY OWN PERSONAL EXPERIENCE WITH HEART DISEASE AND AN EARLY AGE HEART ATTACK. EVERYTHING BELOW HAS NOTHING TO DO WITH THIS TRIAL AND THEY DO HAVE ANY PARTICIPATION AS I EXPLAIN MY OWN EXPERIENCE. I JUST FELT I WOULD GIVE A PORTION OF MY OWN PERSONAL HEART ISSUES WITH YOU - AGAIN THIS ARE MY OWN FEELINGS AND HAVE NOTHING TO DO WITH THE CLINICAL TRIAL. I AM NOT A PHYSICIAN, BUT A PATIENT WITH HEART DISEASE. ****
"MY OWN FEELINGS ARE THAT...Heart disease is something that begins when you are young. The lifestyle you lead, as far as eating habits, exercise, stress reduction, all play an important role in maintaining a healthy life and a healthy heart.
Yet, there are many that suffer from high cholesterol, even though they maintain a "heart healthy lifestyle". Genetics can play an important role in the "clogging" of arteries. Over the years plaque begins to build in your arteries, and eventually can either close off an artery completely or break off and cause a blockage from pieces of that plaque hanging and cutting off oxygen and blood flow.
Therefore it is imperative for everyone who knows they have a "genetic background" (relatives, Father, Mother, Grandparents, siblings and so forth) to be sure and have your cholesterol checked, as well as your blood pressure, heart rate, oxygen levels and so on.
There are also other reasons that cholesterol medications are used. If you have already suffered a heart attack, now they use a combination of certain medications, one of which is a cholesterol, even though you do not have a high cholesterol issue. Several of my physicians have mentioned that those medications taken at a certain dosage together, may help prevent another heart attack by a huge margin. So, cholesterol medications are not just for those with high cholesterol, but for those that may have already had heart disease for other reasons." - All of this is provided by myself, who is a heart attack survivor and my own personal opinions. "Rhia Steele"
***Always see your doctor and/or ask questions about a clinical trial and how it may benefit you or someone you know.
