NCT03044964

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Amit Malhotra, MD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Ranolazine was approved as Ranexa in the United States on January 31, 2006 for the treatment of chronic angina. This post-marketing study is a single-center, double-blind, prospective, randomized, parallel-group evaluation of patients randomized 1:1 between Ranolazine and placebo.

Conditions

• Angina

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-10
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2017-02-07
• Last updated: 2017-02-07

Locations

1 site across 1 country: United States