Phase 4
Completed N=37
Effects of Ranolazine and Exercise on Daily Physical Activity Trial
Chronic Stable Angina
Source: ClinicalTrials.gov NCT01948310 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Change in Peak Oxygen Consumption (VO2 Max) — 0.03; 0.38; 0.9; 2.1 ml/kg/min — p=>0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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
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. Informational only — not medical advice.