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

Gilead Sciences

Status and phase

Withdrawn

Phase 2

Conditions

Ischemic Heart Disease

Treatments

Drug: Placebo

Drug: GS-6615

Study type

Interventional

Funder types

Industry

Identifiers

NCT02377336

GS-US-279-1503

2014-003994-41 (EudraCT Number)

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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