A clinical trial study to assess the effects of Bempedoic acid on heart related events in patients with or at high risk for heart related issues who are unable to tolerate statins (class of drugs that reduce cholesterol in blood)
- Conditions
- Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhereHealth Condition 2: null- Reduction of cardiovascular disease risk
- Registration Number
- CTRI/2017/10/010233
- Lead Sponsor
- Esperion Therapeutics Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Provision of signed informed consent prior to any study-specific procedure.
2. Patient reported statin intolerance (SI) due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued resulting in an inability to tolerate:
• 2 or more statins at any dose, or
• 1 statin at any dose and unwilling to attempt a second statin or advised by a physician to not attempt a second statin.
3. Written confirmation by both patient and investigator that the patient is statin intolerant as defined above, aware of the benefit of statin use to reduce the risk of MACE including death, and also aware that many other patients who are unable to tolerate a statin are able to tolerate a different statin or dose.
4. Age =18 years or legal age of majority based on regional law, whichever is greater, and =85 years at Week -5 (Visit S1).
5.Men and nonpregnant, nonlactating women. Women must be one of the following:
a.Naturally postmenopausal defined as =1 year without menses and:
•=55 years, or
• <55 years with follicle-stimulating hormone (FSH) =40.0 IU/L, or
b.Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation,
or
c.Women of childbearing potential willing to use one acceptable method of birth control during the study and for 30 days after the end of treatment including:
•oral birth control medications,
•placement of an intrauterine device with or without hormones,
•barrier methods including condom or occlusive cap with spermicidal foam or spermicidal jelly,
•vasectomized male partner who is the sole partner for this patient,
•true abstinence (not including periodic abstinence such as calendar, ovulation, symptothermal, postovulation methods, or withdrawal).
There are no protocol-specific birth control requirements for men with partners who are able to become pregnant.
6. Fasting LDL-C =100 mg/dL (2.6 mmol/L) at Week -5 (Visit S1) while taking stable (4 weeks prior to Visit S1) and optimized background LDL-C-lowering therapies that may include very low dose statin (see definition above), ezetimibe, niacin, bile acid resins, fibrates, and/or proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.
Note: A single repeat of LDL-C may be completed prior to initiation of the single-blind Run–in Period. For those patients who have a repeat LDL-C, the repeat value will be used to determine eligibility.
7.History of, or at high risk for, CVD including documented evidence of one or more of the following:
a.Coronary artery disease, defined by:
•MI (either ST-elevation MI or non-ST-elevation MI) occurring greater than 90 days prior to screening, or
•Percutaneous coronary or surgical coronary revascularization, occurring greater than 90 days prior to screening, or
•Angiographic stenosis of >50% in a least 1 major coronary artery (native or graft vessel), as documented by selective coronary angiography or computed tomography angiography (CTA), or
b.Symptomatic peripheral arterial disease (PAD) , defined by:
•Peripheral vascular disease with symptoms of claudication or resting limb ischemia with either ankle brachial index <0.9 performed by a vascular lab or angiogram (including CTA) showing =50% stenosis, or
•Peripheral arterial revascularization (surgical
Patients who meet any of the following criteria will not be eligible to participate:
1.Total fasting TG >500 mg/dL (5.6 mmol/L) at Week -5 (Visit S1).
Note: A single repeat of TG may be completed prior to initiation of the single-blind Run-in Period. For those patients who have a repeat TG, the repeat value will be used to determine eligibility.
2.Renal dysfunction or a glomerulonephropathy defined as either nephritic or nephrotic syndrome, including estimated glomerular filtration rate (eGFR; using central laboratory determined Modification of Diet in Renal Disease [MDRD] formula) <30 mL/min/1.73 m2 at Week -5 (Visit S1).
Note: A single repeat of eGFR may be completed prior to randomization. For those patients who have a repeat eGFR, the repeat value will be used to determine eligibility.
3.Forms of CVD that include any of the following:
a.Recent (within 90 days prior to screening) transient ischemic attack (TIA)
b.Recent (within 90 days of screening) unstable or symptomatic cardiac arrhythmia (including any associated medication changes). Patients with stable well-controlled atrial arrhythmias will be allowed to participate in the study.
c.Patients with implantable pacemakers or automatic implantable cardioverter defibrillators may be considered if deemed by the investigator to be stable for greater than 90 days prior to screening,
d.New York Heart Association (NYHA) Functional Classification Class IV heart failure,
e.Uncontrolled hypertension, defined as mean sitting systolic blood pressure (SBP)
=180 mmHg and/or diastolic blood pressure (DBP) =110 mmHg,
f.Planned coronary revascularization (patient may rescreen 3 months post-procedure).
Note: At the discretion of the investigator, BP medications can be adjusted and/or additional assessment of BP may be completed prior to randomization, with the repeat assessment value used to determine eligibility. Alternatively, patients can be rescreened if BP status has changed.
4.HbA1C =10% at Week -5 (Visit S1).
5.Uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) >1.5 × the upper limit of normal (ULN) at Week -5 (Visit S1). Note: At the discretion of the investigator, thyroid replacement therapy can be adjusted and/or additional measurement of TSH may be completed prior to randomization, with the repeat TSH value used to determine eligibility.
6.Liver disease or dysfunction, including:
a. Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (HCV-ABVivi) at Week -4 (Visit S2), or
b. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) =2.0 × ULN at Week -5 (Visit S1).
Note: At the discretion of the investigator, a single repeat of ALT and/or AST may be completed prior to randomization. For those patients who have a repeat ALT and/or AST, the repeat value will be used to determine eligibility. Also, if test for Hepatitis C antibody is positive, but optional reflexive test for Hepatitis C RNA is negative, patient can be enrolled.
7.Gastrointestinal conditions or procedures (including weight loss surgery; eg, Lap-Band® or gastric bypass) that may affect drug absorption.
8.Hematologic or coagulation disorders or a hemoglobin (Hgb) level <10 g/dL at Week -5 (Visit S1).
9.Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 ye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method