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

• Status: Withdrawn
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

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