What is the PRIMARY Objective?
To evaluate whether the IP versus the placebo reduces the risk of Cardiovascular Death, Nonfatal Heart Attacks, Nonfatal Strokes, or Heart Failure related events.
What condition is considered the "Silent Killer?"
Hypertension
What is the age range for this study?
18 and up.
How is this IP taken?
Sub-Cutaneous (Injection)
What is the Phase of this study?
3
Who is at a higher risk of Cardiovascular Disease? (Be Specific)
People with:
* Type 2 Diabetes
* A HX of Smoking
* Kidney Disease (lowered eGFR)
* A Heart Calcium Score over 100
* Atrial Fibrillation
* An age over 70
What are the diagnostic requirements of this study?
#1) Established Cardiovascular Disease... OR... at risk of Cardio Vascular Disease
AND
#2) DX HTN
How long is the study?
5 years.
What is Cerebrovascular Disease?
A group of conditions that affect the blood vessels supplying the brain.
What medication(s) MUST any "qualified" patient be taking?
1 of 3 pre-approved types of Diuretics
AND
1 pre-approved SOC HTN Medication
How often will the IP for this trial be taken?
every 6 months.
What is the IP?
Zilebesiran
What is Coronary Artery Disease (CAD)?
is a condition where the arteries that supply blood to the heart muscle become narrowed or blocked.
In order to prove a history of ESTABLISHED Cardiovascular Disease to qualify your pt...
Your patient must have experienced one of the 15 pre-approved points that proves evidence of 1 of 3 conditions.
What are the 3 Conditions?
Coronary Artery Disease
Peripheral Artery Disease
Cerebrovascular Disease
What is the common everyday nickname for a Diuretic medication?
A "Water Pill"
What is an "Add On Therapy"?
Treatment added on to a patient's current medication.
What is Peripheral Artery Disease (PAD)?
Blockages in the arteries that carry blood to your limbs.
What is Peripheral Artery Disease (PAD)?
Your patient does not have Est. Cardiovascular Disease.
You now need to prove that they are at risk of Cardiovascular Disease by seeing if they meet 2 of the 9 risk factors.
What are the 9 Risk Factors?
*70 yrs or older
* eGFR lab result less than 60
* suffer and treated for Atrial Fibrillation
* CAC Lab result over 100
* NT-proBNP score greater than 125
* Type 1 DM
* Type 2 DM
* BMI Greater than 30 (27 if Asian)
What is Gio's Birthday?
August 14th.