Overview

This trial is active, not recruiting.

Condition chronic stable angina
Treatments ranolazine, aerobic exercise, placebo
Phase phase 4
Sponsor Duke University
Collaborator Gilead Sciences
Start date December 2013
End date October 2016
Trial size 38 participants
Trial identifier NCT01948310, Pro00045794

Summary

The primary objective is to assess whether the increased angina threshold on ranolazine and subsequent higher training intensity will result in improved exercise tolerance and oxygen consumption; and greater than that observed with exercise training on placebo. The study team anticipates the chronic exercise improvements with ranolazine will be incrementally higher than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key secondary objectives include the acute ranolazine and chronic exercise plus ranolazine effects on total daily energy expenditure (TDEE) and angina-related quality of life.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
ranolazine Renexa
Comparison of Ranolazine 1000mg twice per day versus placebo twice per day
aerobic exercise
Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
(Placebo Comparator)
Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
aerobic exercise
Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
placebo
Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day

Primary Outcomes

Measure
Change in peak oxygen consumption
time frame: Week 1, Week 2 and Week 13

Secondary Outcomes

Measure
Change in treatment satisfaction as measured by the seattle angina questionnaire
time frame: Week 1, Week 2 and Week 13
Change in total daily energy expenditure
time frame: Week 1, Week 2 and Week 13

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Documented CAD diagnosis - Stable angina ≥ 3 months Exclusion Criteria: - Class III or IV heart failure - Myocardial Infarction or coronary revascularization procedure within 2 months - QT interval > 500ms or prescribed medication known to prolong the QTc interval - Contraindicated Medications - Metformin dose > 1700mg/day - Class Ia, Ic and III anti-arrhythmics - CYP3A inhibitors - Simvastatin >20mg/day - Severe renal disease (< 30ml/min creatinine clearance) - Currently on dialysis - Lack of transportation to the exercise and testing facilities - Implanted pacemaker that is not rate responsive

Additional Information

Official title Effects of Ranolazine and Exercise on Daily Physical Activity Trial
Principal investigator William E Kraus, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Duke University.