Clinical trial NCT02377336: GS-6615 in Adults With Chronic Stable Angina and Coronary Artery Disease
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of GS-6615 in Subjects With Chronic Stable Angina and Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ischemic Heart Disease
Keywords: GS-6615
coronary heart disease
angina pectoris
late sodium current
myocardial ischemia
coronary artery disease
chronic stable angina
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in time to 1 mm ST-segment depression
timeFrame: Baseline; Day 13 (± 3 days)
Secondary outcomes:
measure: Change from baseline in total exercise duration at the end of the double-blind treatment period
timeFrame: Baseline; Day 13 (± 3 days)
measure: Time to onset of angina during exercise tolerance testing at the end of the double-blind treatment period
timeFrame: Baseline; Day 13 (± 3 days)
Other outcomes:
Locations:
Study officials:
affiliation: Gilead Sciences
name: Patrick Yue, MD
role: STUDY_DIRECTOR
References: