Alnylam ALN-AGT01-008

Study Details

100

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.

200

What is the Phase of this study?

3

300

What is double-blinded

The patient and the researcher will both not know whether or not the patient is receiving the IP or the placebo.

400

What is the IP?

Zilebesiran

500

What is an "Add On Therapy"?

Treatment added on to a patient's current medication.

Indication Information

100

What condition is considered the "Silent Killer?"

Hypertension

200

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

300

What is Cerebrovascular Disease?

A group of conditions that affect the blood vessels supplying the brain.

400

What is Coronary Artery Disease (CAD)?

is a condition where the arteries that supply blood to the heart muscle become narrowed or blocked.

500

What is Peripheral Artery Disease (PAD)?

Blockages in the arteries that carry blood to your limbs.

What is Peripheral Artery Disease (PAD)?

Inclusion Criteria

100

What is the age range for this study?

18 and up. 

200

What are the diagnostic requirements of this study?

#1) Established Cardiovascular Disease... OR... at risk of Cardio Vascular Disease

                                 AND 

#2) DX HTN

300

What medication(s) MUST any "qualified" patient be taking?

1 of 3 pre-approved types of Diuretics

                                 AND

1 pre-approved SOC HTN Medication

400

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

500

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)

WILD CARDS

100

How is this IP taken? 

Sub-Cutaneous (Injection)

200

How long is the study?

5 years.

300

How often will the IP for this trial be taken?

every 6 months. 

400

What is the common everyday nickname for a Diuretic medication?

A "Water Pill"

500

What is Gio's Birthday?

August 14th.