GS-6615 in Adults With Chronic Stable Angina and Coronary Artery Disease

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of GS-6615 in Subjects With Chronic Stable Angina and Coronary Artery Disease

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.

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