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

NCT02377336 | Withdrawn Phase 2

• 2 other identifiers: GS-US-279-15032014-003994-41
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Heart Disease

Keywords

GS-6615; coronary heart disease; angina pectoris; late sodium current; myocardial ischemia; coronary artery disease; chronic stable angina

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (2)

GS-6615

EXPERIMENTAL

GS-6615 30 mg (5 x 6 mg) on Day 1, followed by 6 mg twice daily

Drug: GS-6615

Placebo

PLACEBO COMPARATOR

Placebo to match GS-6615 (5 tablets) on Day 1, followed by placebo to match GS-6615 twice daily

Drug: Placebo

Interventions

GS-6615 DRUG

GS-6615 tablets administered orally

GS-6615

Placebo DRUG

Placebo to match GS-6615 tablets administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Disease; Angina Pectoris; Coronary Artery Disease; Angina, Stable

Interventions

eleclazine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Patrick Yue, MD

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 3, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 8, 2015

Record last verified: 2015-06