Ischemic Heart Disease
Conditions
Keywords
GS-6615, coronary heart disease, angina pectoris, late sodium current, myocardial ischemia, coronary artery disease, chronic stable angina
Brief summary
This study will evaluate the effect of GS-6615 in adults with chronic stable angina and coronary artery disease (CAD) receiving a stable daily dose of up to 2 antianginal medications. The study will consist of two periods: a 1 to 3 week Qualifying Period and a Treatment Period lasting 13 days (± 3 days). During the Qualifying Period and at the end of the Treatment Period, participants will undergo exercise tolerance testing.
Interventions
DRUGPlacebo
Placebo to match GS-6615 tablets administered orally
DRUGGS-6615
GS-6615 tablets administered orally
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Able to perform a standardized treadmill exercise protocol * At least a 3 month history of chronic stable angina triggered by physical effort and relieved by rest and/or short-acting nitroglycerin * Coronary artery disease (CAD) documented by one or more of the following: * Angiographic evidence (either invasive or noninvasive) of ≥ 50% stenosis of one or more major coronary arteries * History of myocardial infarction (MI) documented by positive creatine kinase-myocardial band (CK-MB) enzymes, troponins, or electrocardiogram (ECG) changes * Noninvasive imaging stress test diagnostic of CAD (eg, nuclear perfusion scan, stress echocardiogram, stress cardiac magnetic resonance scan) * Stable antianginal treatment with up to 2 antianginal agents
Exclusion criteria
* Inability to exercise or having exercise limitation due to other co-morbidities that may interfere with ability to perform required exercise tolerance testing (ETT) * Presence of electrocardiographic or other abnormalities that interfere with ECG interpretation or may cause a false positive stress test * History of heart failure as defined by New York Heart Association Class III-IV and/or known left ventricular ejection fraction ≤ 45% * History of severe disabling angina as defined by Canadian Cardiovascular Society Class IV * Myocardial infarction, acute coronary syndrome or coronary revascularization within 3 months prior to screening, or planned coronary revascularization during the study period * Stroke or transient ischemic attack within 6 months prior to screening * Chronic persistent atrial fibrillation * Uncontrolled hypertension (seated systolic blood pressure (SBP) \> 160 mm Hg or diastolic blood pressure (DBP) \> 110 mm Hg) * Body mass index (BMI) ≥ 36 kg/m\^2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in time to 1 mm ST-segment depression | Baseline; Day 13 (± 3 days) | For treadmill-related endpoints, baseline is defined as the value derived from the last exercise tolerance testing performed during the qualifying period. |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in total exercise duration at the end of the double-blind treatment period | Baseline; Day 13 (± 3 days) |
| Time to onset of angina during exercise tolerance testing at the end of the double-blind treatment period | Baseline; Day 13 (± 3 days) |
Outcome results
None listed