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

Phase 2

Withdrawn

• Conditions: Ischemic Heart Disease
• Interventions: Drug: GS-6615; Drug: Placebo

• Registration Number: NCT02377336
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-03-03
• Study Start: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-06-08
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GS-6615	GS-6615	GS-6615 30 mg (5 x 6 mg) on Day 1, followed by 6 mg twice daily
Placebo	Placebo	Placebo to match GS-6615 (5 tablets) on Day 1, followed by placebo to match GS-6615 twice daily

Primary Outcome Measures

Name	Time	Method
Change from baseline in time to 1 mm ST-segment depression	Baseline; Day 13 (± 3 days)	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

Name	Time	Method
Time to onset of angina during exercise tolerance testing at the end of the double-blind treatment period	Baseline; Day 13 (± 3 days)
Change from baseline in total exercise duration at the end of the double-blind treatment period	Baseline; Day 13 (± 3 days)