Ischemic Heart DiseasePhase 2NCT02377336
GS-6615 in Adults With Chronic Stable Angina and Coronary Artery Disease
A Phase 2 study testing GS-6615 in people with Ischemic Heart Disease, run by Gilead Sciences.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- GS-6615
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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
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
- Being tested
- GS-6615, Placebo
- Keywords
- GS-6615, coronary heart disease, angina pectoris, late sodium current, myocardial ischemia, coronary artery disease, chronic stable angina
- Medical subject headings
- Myocardial Ischemia, Coronary Disease, Angina Pectoris, Coronary Artery Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-6615Drug
GS-6615 tablets administered orally
PlaceboDrug
Placebo to match GS-6615 tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| GS-6615 | Experimental | GS-6615 30 mg (5 x 6 mg) on Day 1, followed by 6 mg twice daily Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Day 13 (± 3 days)
Secondary outcomes (2)
Change from baseline in total exercise duration at the end of the double-blind treatment period
Measured: Baseline; Day 13 (± 3 days)
Time to onset of angina during exercise tolerance testing at the end of the double-blind treatment period
Measured: Baseline; Day 13 (± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: Anticipated recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Yue, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377336
- Sponsor's protocol ID
- GS-US-279-1503
- Other IDs
- 2014-003994-41, 2014
- Status last verified
- Jun 2015
- First submitted
- 26 Feb 2015
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02377336
- Acronym / sponsor ID
- GS-US-279-1503
- Conditions
- Ischemic Heart Disease
- Keywords
- GS-6615, coronary heart disease, angina pectoris, late sodium current, myocardial ischemia, coronary artery disease, chronic stable angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Anticipated recruitment challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS-6615 | Experimental | Drug: GS-6615GS-6615 30 mg (5 x 6 mg) on Day 1, followed by 6 mg twice daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match GS-6615 (5 tablets) on Day 1, followed by placebo to match GS-6615 twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Stable antianginal treatment with up to 2 antianginal agents
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-6615GS-6615 tablets administered orally | Drug | GS-6615 |
| PlaceboPlacebo to match GS-6615 tablets administered orally | Drug | Placebo |
Primary outcome
Change from baseline in time to 1 mm ST-segment depression
Time frame: 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.
2 secondary outcomes
Change from baseline in total exercise duration at the end of the double-blind treatment period
Time frame: Baseline; Day 13 (± 3 days)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Yue, MD study director
Gilead Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS-6615 in people with Ischemic Heart Disease, run by Gilead Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in time to 1 mm ST-segment depression (time frame: Baseline; Day 13 (± 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.