Effects of Ranolazine and Exercise on Daily Physical Activity Trial

NCT ID: NCT01948310

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-10-10

Brief 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.

Conditions

Chronic Stable Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ranolazine plus Exercise

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.

Group Type: ACTIVE_COMPARATOR

Ranolazine

Intervention Type: DRUG

Comparison of Ranolazine 1000mg twice per day versus placebo twice per day

Aerobic Exercise

Intervention Type: BEHAVIORAL

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 plus Exercise

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.

Group Type: PLACEBO_COMPARATOR

Aerobic Exercise

Intervention Type: BEHAVIORAL

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

Intervention Type: DRUG

Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day

Interventions

Ranolazine

Comparison of Ranolazine 1000mg twice per day versus placebo twice per day

Intervention Type: DRUG

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)

Intervention Type: BEHAVIORAL

Placebo

Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day

Intervention Type: DRUG

Other Intervention Names

Renexa

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William E Kraus, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Center for Living

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00045794

Identifier Type: -

Identifier Source: org_study_id