Microvascular Assessment of Ranolazine in Non-Obstructive Atherosclerosis (MARINA)

NCT02147067 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00072996
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at the effects of the drug Ranolazine compared to Placebo on symptoms of chest pain or chest tightness (known as angina), exercise endurance and ability, and changes in blood flow to the very small arteries of the heart (known as coronary microvascular function) in patients who do not have significant blockages in their major heart arteries. Ranolazine is a drug that is already approved by the FDA for angina, but it may be particularly effective in people with disease in their tiny heart vessels (known as coronary microvascular disease). This trial aims to enroll 50 patients with angina who undergo baseline bicycle exercise testing with monitoring of the heart's electrical activity and oxygen consumption (known as cardiopulmonary exercise test) and coronary angiogram (taking pictures of the heart arteries through small hollow tubes placed through the wrist or groin). If severe blockages in the main arteries are not found then testing for coronary microvascular function will be performed. Subsequently, participants will then be randomized 50/50 to either Ranolazine or Placebo. After taking the study drug for 12 weeks, they will then repeat the cardiopulmonary exercise test and the coronary angiogram with testing for microvascular function.

Conditions

Microvascular Angina

Keywords

microvascular angina; coronary microvascular disease; coronary physiology; ranolazine

Outcome Measures

Primary Outcomes (1)

• Change in Seattle Angina Questionnaire Score Regarding Angina Frequency

  The change in scores of the angina frequency dimension of the Seattle Angina Questionnaire (SAQ) after 12 weeks therapy with ranolazine or placebo are presented. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline. Individual dimensions of the Seattle Angina Questionnaire are transformed to be a score from 0 to 100, where higher scores indicate better health. A positive number for the angina frequency dimension means that the participants are experiencing fewer episodes of angina at week 12 than they were at the baseline visit.

  Baseline, Week 12

Secondary Outcomes (10)

• Change in Seattle Angina Questionnaire Score Regarding Physical Limitation

  Baseline, Week 12

• Change in Seattle Angina Questionnaire Score Regarding Angina Stability

  Baseline, Week 12

• Change in Seattle Angina Questionnaire Score Regarding Treatment Satisfaction

  Baseline, Week 12

• Change in Seattle Angina Questionnaire Score Regarding Disease Perception

  Baseline, Week 12

• Change in Peak Rate of Oxygen Consumption (VO2 Max)

  Baseline, Week 12

Study Arms (2)

Ranolazine

EXPERIMENTAL

Ranolazine 1,000 mg twice daily

Drug: Ranolazine

Placebo

PLACEBO COMPARATOR

Placebo twice daily

Drug: Placebo

Interventions

Ranolazine DRUG

Ranolazine 1,000 mg twice daily

Also known as: Ranexa

Ranolazine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• History of typical angina or effort-induced anginal symptoms and are currently experiencing angina at least once per week
• Abnormal stress ECG, exercise stress imaging, or pharmacological stress imaging
• Non-obstructive coronary artery disease as defined by lesion stenosis ≤ 50% in any artery as visualized by diagnostic angiography

You may not qualify if:

• Inability to provide informed consent
• Active Myocardial Infarction
• History of coronary artery bypass grafting
• Diagnosis of other specific cardiac disease such as severe valvular heart disease, cardiomyopathy, or variant angina
• Left Ventricular Ejection Fraction (LVEF) \< 30%
• Known renal insufficiency (CrCl \< 30 mL/min) or on dialysis
• Contraindications to the use of Ranolazine

Sponsors & Collaborators

• Emory University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• Koh JS, Hung OY, Eshtehardi P, Kumar A, Rabah R, Raad M, Kumar S, Chaudhry S, Gupta S, Hosseini H, Brilakis E, Corban M, Sabbak N, Burnett GM, Liu C, Mehta PK, Quyyumi AA, Samady H. Microvascular Assessment of Ranolazine in Non-Obstructive Atherosclerosis: The MARINA Randomized, Double-Blinded, Controlled Pilot Trial. Circ Cardiovasc Interv. 2020 Dec;13(12):e008204. doi: 10.1161/CIRCINTERVENTIONS.119.008204. Epub 2020 Dec 4.

  PMID: 33272036 DERIVED

• Titterington JS, Hung OY, Wenger NK. Microvascular angina: an update on diagnosis and treatment. Future Cardiol. 2015 Mar;11(2):229-42. doi: 10.2217/fca.14.79.

  PMID: 25760881 DERIVED

MeSH Terms

Conditions

Microvascular Angina

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Habib Samady, MD
• Organization: Emory University

hsamady@emory.edu

(404) 778-1237

Study Officials

• Habib Samady, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 26, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 21, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-05

Locations

US (1)