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

NCT01562041 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CPJMR0032105
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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).

Conditions

Atherosclerotic Coronary Vascular Disease

Keywords

Cardiovascular disease; Exercise Treadmill Test; Ranolazine; Angina; Myocardial ischemia

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline up to Day 15

Secondary Outcomes (3)

• Change From Baseline in Total Exercise Duration

  Baseline up to Day 15

• Change From Baseline in Time to Onset of 1 mm ST Segment Depression (Time to Ischemia)

  Baseline up to Day 15

• Change From Baseline in Time to Onset of Angina

  Baseline up to Day 15

Study Arms (1)

Ranolazine 500 mg

EXPERIMENTAL

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

Drug: Ranolazine 500 mg

Interventions

Ranolazine 500 mg DRUG

Ranolazine 500 mg, oral tablet, b.i.d.

Also known as: Ranexa®

Ranolazine 500 mg

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of stable coronary artery disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Jacksonville, Florida, 32216, United States

Location

Novartis Investigative Site

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Angina Pectoris; Myocardial Ischemia

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 23, 2012
• Study Start: March 9, 2012
• Primary Completion: January 2, 2014
• Study Completion: January 2, 2014
• Last Updated: June 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-05

Locations

US (2)