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Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention (REPTAR)

NCT03044964 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-02-07

No results posted yet for this study

Summary

The post-marketing study is designed to evaluate the activity level and exercise tolerance of patients with deferred percutaneous intervention due to FFR (fractional flow reserve) greater or equal to 0.81 and treatment with Ranolazine versus placebo.

Conditions

  • Angina

Interventions

DRUG

Ranolazine

Patients will be started on 500mg twice daily and may be increased to 1000mg twice daily after 1 week. Patients will or may remain on the 1000mg for 5 weeks.

DRUG

Placebo

Patients will be started on 500mg twice daily and may be increased to 1000mg twice daily after 1 week. Patients will or may remain on the 1000mg for 5 weeks.

Sponsors & Collaborators

Principal Investigators

  • Amit Malhotra, MD · Stern Cardiovascular Foundation, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-10
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044964 on ClinicalTrials.gov