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.

Study Overview

• Status: Withdrawn
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Drug: GS-6615; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GS-6615; GS-6615 30 mg (5 x 6 mg) on Day 1, followed by 6 mg twice daily	Drug: GS-6615; GS-6615 tablets administered orally
Placebo Comparator: Placebo; Placebo to match GS-6615 (5 tablets) on Day 1, followed by placebo to match GS-6615 twice daily	Drug: Placebo; Placebo to match GS-6615 tablets administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in time to 1 mm ST-segment depression	For treadmill-related endpoints, baseline is defined as the value derived from the last exercise tolerance testing performed during the qualifying period.	Baseline; Day 13 (± 3 days)

Secondary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: coronary artery disease; angina pectoris; coronary heart disease; myocardial ischemia; chronic stable angina; GS-6615; late sodium current
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina, Stable
• Other Study ID Numbers: GS-US-279-1503; 2014-003994-41 (EudraCT Number)