Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease

Phase 2

Terminated

• Conditions: Atherosclerotic Coronary Vascular Disease
• Interventions: Drug: Ranolazine 500 mg

• Registration Number: NCT01562041
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-09
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Primary Completion: 2014-01-02
• Study Completion: 2014-01-02
• Results First Submitted: 2021-04-30
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Results First Posted: 2021-06-18
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• History of stable coronary artery disease

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranolazine 500 mg	Ranolazine 500 mg	Participants received ranolazine 500 milligrams (mg), orally, twice daily (b.i.d.) up to 14 days.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Total Exercise Duration	Baseline up to Day 15	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.
Change From Baseline in Time to Onset of 1 mm ST Segment Depression (Time to Ischemia)	Baseline up to Day 15	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.
Change From Baseline in Time to Onset of Angina	Baseline up to Day 15	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 New York, New York, United States