Trial Outcomes & Findings for Impact of Ranolazine on Coronary Microcirculatory Resistance (NCT NCT01815957)

NCT ID: NCT01815957

Last Updated: 2023-12-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2023-12-26

Participant Flow

Publication: Title: Impact of ranolazine on coronary microvascular dysfunction (MICRO) study Published in Cardiovascular Revascularization Medicine: Volume 18, Issue 6, September 2017, Pages 431-435 Please refer to Table 1 for the Baseline Demographic Variables

Participant milestones

Measure	Ranalozine After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated. Rnalozine: . After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated.
Overall Study STARTED	7
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Ranolazine on Coronary Microcirculatory Resistance

Baseline characteristics by cohort

Measure	Ranalozine n=7 Participants After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated. Rnalozine: . After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	57.6 years n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	7 Participants n=93 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure

Ranalozine n=7 Participants After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated. Rnalozine: . After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated.

Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy

7 Participants

Adverse Events

Ranalozine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ranalozine Titration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bina Ahmed

UNewMexico

Phone: 505-272-7028

Email: hkhawaja@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place