Heart Disease Self-Scheduler

Basic Criteria 

• Age 18 or older 

• Must meet one of the following criteria: 

• • Have a history of a cardiovascular event such as heart attack, stable or unstable angina, coronary or other arterial revascularization, stroke, or peripheral artery disease. OR 

• • Be at risk for a first heart condition with one or more of the following conditions: atherosclerotic vascular disease, diabetes, high blood pressure, cigarette smoking (tobacco products and includes vaping), chronic kidney disease (moderate to severe stages), or obesity 

• Must be on a high dose statin-atorvastatin 40 mg or rosuvastatin 20 mg- 

• • Except patients with documented intolerable side effects to at least 2 different statins. 

Answers Must be NO 

• If female, are you currently pregnant, breast-feeding or planning to become pregnant during the study? 

• Do you have an inherited genetic disorder that causes very high levels of “bad” cholesterol (called LDL cholesterol) in the blood? 

• Do you have uncontrolled high blood pressure with systolic BP > 160 mmHg or diastolic BP > 110 mmHg? 

• In the past 5 years, have you abused any drugs or alcohol? 

• • Alcohol abuse is defined as consuming more than 14 drinks/week for males or more than 7/week for females 

• • Absolutely no hard drugs like heroine. Marijuana use ok on a case by case basis  

• Do you have uncontrolled type 2 diabetes with HbA1C ≥ 9.5%? 

• Do you have any major active infections like hepatitis B and C? 

• In the past 12months, have you undergone an LDL or plasma apheresis (a procedure to remove plasma or cholesterol from the blood)? 

• Is your life expectancy less than 2 years? 

• Have you received inadequate treatment for hypothyroidism, or have any changes to dose for thyroid replacement therapy in the last 3 months? 

• Do you have any of the following conditions?  

• • Stage 5 kidney disease  

• • Class IV heart failure 

• • Ventricular arrhythmia requiring treatment 

• • Previously diagnosed hypertrophic obstructive or infiltrative heart disease such as sarcoidosis or amyloidosis 

• Have you taken any of the following medications? 

• • Used any medication that contains a black box warning for significant QT prolongation in the past 14 days 

• • Used mipomersen or lomitapide (cholesterol-lowering medications) within 12 months or planned use during the study  

• • Used gemfibrozil within the past 1 week or plan to use during the study 

• • Used PCSK-9 inhibitors: evolocumab/alirocumab within the past 12 weeks or planned use during the study 

• • Used inclisiran within the past 18 months  

• Have you received any major organ transplants, e.g., lungs, liver, heart, bone marrow, or kidney? 

• In the past 5 years have you had any cancer? Exception: non-melanoma skin cancers, cervical in-situ carcinoma 

• In the past 7 days, have you had any acute cardiovascular events? For example, heart attack, stroke, DVT’s (blood clots), pulmonary embolism) 

• Do you have any other medical conditions or surgery that may hinder you from participating in this study? 

• In the past 30 days, have you participated in another clinical trial involving investigational drug or device? 

• Are you a staff member or related to anyone working at AstraZeneca or Flourish San Antonio? 

• Have you previously participated in this study? 

Answers Must be YES 

• If female and of childbearing potential, are you willing to use one highly effective form of birth control from screening throughout the study and for at least 10 days after last dose of study drug? The following are allowed: 

• • Hormonal contraception; oral, transdermal, injectable, implantable, intravaginal 

• • IUD, IUS 

• • Bilateral tubal occlusion 

• • Tubal ligation/tubes tied 

• • Vasectomized partner 

• • Total sexual abstinence provided it is the usual lifestyle of the participant 

• • Same sex partner 

• If female and not of childbearing potential, do you meet one of the following criteria? 

• • Permanently sterilized via hysterectomy, having both ovaries removed, or both fallopian tubes removed OR 

• • Postmenopausal for at least 12months with no cycle 

• Are you capable of signing consent independently, and willing to comply with all study visit requirements? 

• Are you willing to refrain from blood and plasma donation throughout the study? 

Compensation up to $1,814 may be available for time and travel

Insurance is not required 

PLEASE NOTE: If you do not see an available appointment, please call 210-714-0067 for availability