Phase 4 N=37 Randomized Quadruple-blind Treatment

Effects of Ranolazine and Exercise on Daily Physical Activity Trial

Chronic Stable Angina

Bottom Line

View on ClinicalTrials.gov: NCT01948310 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: Change in Peak Oxygen Consumption (VO2 Max) — 0.03; 0.38; 0.9; 2.1 ml/kg/min — p=>0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ranolazine (Drug); Aerobic Exercise (Behavioral); Placebo (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Duke University
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Peak Oxygen Consumption (VO2 Max)	0.03; 0.38; 0.9; 2.1	>0.05
SECONDARY Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire	0.8; 5.3; 3.1; -1.0	>0.05
SECONDARY Change in Total Daily Energy Expenditure	2.0; -7.6; 22.2; 24.3	>0.05

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01948310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.