Back to results

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

Primary Purpose

Ischemic Heart Disease

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

GS-6615

Placebo

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring GS-6615, coronary heart disease, angina pectoris, late sodium current, myocardial ischemia, coronary artery disease, chronic stable angina

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GS-6615

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in total exercise duration at the end of the double-blind treatment period

Time to onset of angina during exercise tolerance testing at the end of the double-blind treatment period

Full Information

NCT ID

NCT02377336

First Posted

February 26, 2015

Last Updated

June 4, 2015

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02377336

Brief Title

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

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Anticipated recruitment challenges

Study Start Date

May 2015 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GS-6615

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GS-6615

Intervention Description

GS-6615 tablets administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to match GS-6615 tablets administered orally

Primary Outcome Measure Information:

Title

Change from baseline in time to 1 mm ST-segment depression

Description

For treadmill-related endpoints, baseline is defined as the value derived from the last exercise tolerance testing performed during the qualifying period.

Time Frame

Baseline; Day 13 (± 3 days)

Secondary Outcome Measure Information:

Title

Change from baseline in total exercise duration at the end of the double-blind treatment period

Time Frame

Baseline; Day 13 (± 3 days)

Title

Time to onset of angina during exercise tolerance testing at the end of the double-blind treatment period

Time Frame

Baseline; Day 13 (± 3 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Yue, MD

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs