Atherosclerotic Coronary Vascular DiseasePhase 2NCT01562041
Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease
A Phase 2 study testing Ranolazine 500 mg in people with Atherosclerotic Coronary Vascular Disease, run by Novartis Pharmaceuticals at 2 sites in United States.
Trial summary
The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Atherosclerotic Coronary Vascular Disease
- What is being tested?
- Ranolazine 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Mar 2012to 2 Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of stable coronary artery disease
Who cannot join
- Inability or unwillingness to participate in multiple exercise treadmill tests and/or any other requirements of this study as assessed by the Investigator.
- History of chronic atrial fibrillation.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
New York, New York, 10021
About this study
Official title: Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease
The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).
- Being tested
- Ranolazine 500 mg
- Keywords
- Cardiovascular disease, Exercise Treadmill Test, Ranolazine, Angina, Myocardial ischemia
- Medical subject headings
- Cardiovascular Diseases, Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranolazine 500 mgDrug
Also called Ranexa®
Ranolazine 500 mg, oral tablet, b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine 500 mg | Experimental | Participants received ranolazine 500 milligrams (mg), orally, twice daily (b.i.d.) up to 14 days. Receives: Drug: Ranolazine 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index
ST/HR index was measured as the average change in ST segment depression relative to heart rate change over the entire duration of exercise, monitored by ECG during the exercise treadmill tests. Change in maximum ST/HR index between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
Measured: Baseline up to Day 15
Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Slope
ST-HR slope is an index of exercise induced ischemia. Linear regression was used to determine the slope of the ST/HR relationship in a participant's ECG response monitored during the exercise treadmill test. The highest ST segment/heart rate slope from among all the ECG leads and the X-axis intercept of the associated line were used to generate the maximum slope. Change in maximum ST-HR slope between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
Measured: Baseline up to Day 15
Change From Baseline in X-Axis Intercept of ST-HR Slope
Linear regression was used to determine the slope of the ST/HR relationship in a participant's ECG response monitored during the exercise treadmill test. Change in X- axis intercept of ST-HR slope between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
Measured: Baseline up to Day 15
Secondary outcomes (3)
Change From Baseline in Total Exercise Duration
Total exercise duration was defined as the elapsed time between the start of exercise and termination of exercise for severe angina, dyspnea or extreme fatigue assessed during the exercise treadmill test. Change in the duration of exercise between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
Measured: Baseline up to Day 15
Change From Baseline in Time to Onset of 1 mm ST Segment Depression (Time to Ischemia)
Exercise-induced ischemia was defined as the new development of horizontal or down sloping ST-segment depression (≥ 1 mm at 60 milliseconds after the J point) vs. baseline tracings. Change in time to onset of 1 mm ST depression between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
Measured: Baseline up to Day 15
Change From Baseline in Time to Onset of Angina
Time to onset of angina was defined as the elapsed time between the start of exercise and the onset of anginal chest pain as reported by the participant. Change in time to angina between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
Measured: Baseline up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study start9 Mar 2012
- Primary completion2 Jan 2014
- Study completion2 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atherosclerotic Coronary Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562041
- Sponsor's protocol ID
- CPJMR0032105
- Status last verified
- May 2021
- First submitted
- 21 Mar 2012
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01562041
- Acronym / sponsor ID
- CPJMR0032105
- Keywords
- Cardiovascular disease, Exercise Treadmill Test, Ranolazine, Angina, Myocardial ischemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2012 (actual)
- Primary completion
- 2 Jan 2014 (actual)
- Study completion
- 2 Jan 2014 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranolazine 500 mg | Experimental | Drug: Ranolazine 500 mgParticipants received ranolazine 500 milligrams (mg), orally, twice daily (b.i.d.) up to 14 days. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of stable coronary artery disease
Key exclusion criteria (3 listed)
- Inability or unwillingness to participate in multiple exercise treadmill tests and/or any other requirements of this study as assessed by the Investigator.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Ranolazine 500 mgAlso: Ranexa®Ranolazine 500 mg, oral tablet, b.i.d. | Drug | Ranolazine 500 mg |
Primary outcome
Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index
Time frame: Baseline up to Day 15
ST/HR index was measured as the average change in ST segment depression relative to heart rate change over the entire duration of exercise, monitored by ECG during the exercise treadmill tests. Change in maximum ST/HR index between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Slope
Time frame: Baseline up to Day 15
ST-HR slope is an index of exercise induced ischemia. Linear regression was used to determine the slope of the ST/HR relationship in a participant's ECG response monitored during the exercise treadmill test. The highest ST segment/heart rate slope from among all the ECG leads and the X-axis intercept of the associated line were used to generate the maximum slope. Change in maximum ST-HR slope between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
Change From Baseline in X-Axis Intercept of ST-HR Slope
Time frame: Baseline up to Day 15
Linear regression was used to determine the slope of the ST/HR relationship in a participant's ECG response monitored during the exercise treadmill test. Change in X- axis intercept of ST-HR slope between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported.
3 secondary outcomes
Change From Baseline in Total Exercise Duration
Time frame: Baseline up to Day 15
Change From Baseline in Time to Onset of 1 mm ST Segment Depression (Time to Ischemia)
Time frame: Baseline up to Day 15
Change From Baseline in Time to Onset of Angina
Time frame: Baseline up to Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranolazine 500 mg in people with Atherosclerotic Coronary Vascular Disease, run by Novartis Pharmaceuticals at 2 sites in United States.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index (time frame: Baseline up to Day 15). The study lists 3 primary outcomes in all. 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 18 Jun 2021.