Effects of Ranolazine and Exercise on Daily Physical Activity Trial

NCT01948310 | Completed Phase 4 Results DMC

• 1 other identifier: Pro00045794
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Peak Oxygen Consumption (VO2 Max)

  This test involves exercising on a treadmill or bike to maximal exertion, during which the subject's breathing and oxygen consumption are measured. Under a set study protocol, treadmill or bike workload will increase every minute until the participant either chooses to end the test or the study personnel choose to end the test for safety purposes.

  Baseline, Week 2 and Week 14

Secondary Outcomes (2)

• Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire

  Baseline, Week 2 and Week 14

• Change in Total Daily Energy Expenditure

  Week 1, Week 4 and Week 14

Study Arms (2)

Ranolazine plus Exercise

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.

Drug: Ranolazine; Behavioral: Aerobic Exercise

Placebo plus Exercise

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.

Behavioral: Aerobic Exercise; Drug: Placebo

Interventions

Ranolazine DRUG

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

Also known as: Renexa

Ranolazine plus Exercise

Aerobic Exercise 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; Ranolazine plus Exercise

Placebo DRUG

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

Placebo plus Exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented CAD diagnosis
• Stable angina ≥ 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Duke Center for Living

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Angina, Stable

Interventions

Ranolazine; Exercise

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular 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; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Leslie Willis
• Organization: Duke Medical Center

leslie.willis@duke.edu

9196606782

Study Officials

• William E Kraus, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 23, 2013
• Study Start: December 1, 2013
• Primary Completion: October 10, 2016
• Study Completion: October 10, 2016
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2017-11

Locations

US (1)