Trial · NCT01754259

Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD

NCT01754259, Phase 3, Completed, Brigham and Women's Hospital; results first posted 2017-07-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD. Trials, record NCT01754259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01754259

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD
NCT number: NCT01754259
Status: Completed
Phases: Phase 3
Enrollment: 47 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Diabetes, Type I, Diabetes, Type II, Angina, Coronary Artery Disease
Interventions: Ranolazine, Placebo
First posted: 2012-12-21
Last updated: 2017-07-24
Results first posted: 2017-07-24
Limitations and caveats: The limitations for our study include a relatively small cohort size of 47 patients, that our mechanistic trial was not designed to assess clinical outcomes and that our experimental design allowed for inclusion of patients with non-obstructive CAD.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Post-exercise Coronary Vasodilator Reserve	4 weeks	Change (from baseline) in post-exercise coronary vasodilator reserve, as measured by PET imaging at 4 weeks post randomization. Per-patient global coronary flow reserve (CFR) was calculated as the ratio of absolute MBF at stress over rest for the entire left ventricle. Quantitation of MBF was performed by two operators blinded to patient, treatment period and treatment order.
Secondary	Change in LV Diastolic Function	4 weeks	Change (from baseline) in LV diastolic function reflected primarily in mitral annular early diastolic relaxation velocity (E') at 4 weeks post randomization. LV end-diastolic and end-systolic volumes (used to calculate LVEF), left atrial volume, septal and lateral peak early diastolic tissue velocity (e'), septal and lateral peak systolic tissue velocity (s'), and mitral inflow velocity (E) were all measured in accordance with ASE guidelines.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Post-exercise Coronary Vasodilator Reserve	4 weeks		% change	NUMBER
SECONDARY	Change in LV Diastolic Function	4 weeks		% change	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Change in Post-exercise Coronary Vasodilator Reserve	Ranolazine	-4	% change
Change in Post-exercise Coronary Vasodilator Reserve	Placebo	2	% change
Change in LV Diastolic Function	Ranolazine	1	% change
Change in LV Diastolic Function	Placebo	-2	% change

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ranolazine	23
Overall Study	STARTED	Placebo	24
Overall Study	COMPLETED	Ranolazine	18
Overall Study	COMPLETED	Placebo	18
Overall Study	NOT COMPLETED	Ranolazine	5
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea and Dizziness	Nervous system disorders	Ranolazine	9	23	9
other	Nausea and Dizziness	Nervous system disorders	Placebo	0	24	0
other	Hypoglycemia	Endocrine disorders	Ranolazine	1	23	1
other	Hypoglycemia	Endocrine disorders	Placebo	0	24	0
other	Renal abnormality	Renal and urinary disorders	Ranolazine	1	23	1
other	Renal abnormality	Renal and urinary disorders	Placebo	0	24	0
other	Transaminitis	Hepatobiliary disorders	Ranolazine	1	23	1
other	Transaminitis	Hepatobiliary disorders	Placebo	0	24	0
other	Hematuria	Renal and urinary disorders	Ranolazine	0	23	0
other	Hematuria	Renal and urinary disorders	Placebo	1	24	1

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ranolazine	0	23
Total, all-cause mortality	Placebo	0	24
Total, other adverse events	Ranolazine	12	23
Total, other adverse events	Placebo	2	24
Total, serious adverse events	Ranolazine	0	23
Total, serious adverse events	Placebo	1	24

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28473401	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ranolazine vs Placebo: deaths from any cause	Trial comparisons
Ranolazine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01754259

GET https://conductscience.org/api/trials/v1/NCT01754259/registered

API reference For AI assistants