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Ranolazine for Coronary Microcirculation Dysfunction
N/A
Waitlist Available
Led By Bina Ahmed, MD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to see if it improves blood flow in the heart for people with coronary microcirculation dysfunction. They are also seeing if chest pain improves with the drug.
Who is the study for?
This trial is for adults with symptoms of ischemia, such as chest pain and ECG changes, but without severe blockages in their heart arteries. They must have abnormal blood flow measurements in the small vessels of the heart and can't be pregnant or breastfeeding, have liver problems, a very weak heart valve, recent heart attacks, or be on certain other medications.Check my eligibility
What is being tested?
The study tests whether Ranolazine can improve how well the smallest blood vessels in the heart work in patients who experience chest pain due to poor microcirculation. It also examines if relief from chest pain correlates with better vessel function.See study design
What are the potential side effects?
Ranolazine may cause dizziness, headache, constipation or nausea. It might affect liver enzymes and could potentially lead to changes in heartbeat rhythm (QT prolongation), especially when combined with specific drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy
Secondary outcome measures
Absolute change in SAQ and DASI scores before and after Ranolazine therapy.
Compare relative change in IMR among patients with and without symptomatic improvement in angina burden based on SAQ and DASI scores.
Trial Design
1Treatment groups
Experimental Treatment
Group I: RanalozineExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ranolazine
FDA approved
Find a Location
Who is running the clinical trial?
University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,782 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,255 Total Patients Enrolled
Bina Ahmed, MDPrincipal InvestigatorAssistant Professor, IM Div Cardiology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have blockages in the heart arteries that are more than 50% narrowed.You have a serious narrowing of the aortic valve in your heart.You are unable to undergo certain tests or receive specific medications.You are not expected to live longer than 6 months.You had a heart attack within the past week or have positive markers for heart damage.You cannot participate if you have liver problems, kidney problems, are pregnant, breastfeeding, or taking certain medications that affect the heart.You have symptoms of reduced blood flow to the heart, but tests show that the blockage in the heart's blood vessels is not severe.Ischemia is when you have chest pain along with specific changes on an ECG test, or certain abnormal results on exercise or stress tests.
Research Study Groups:
This trial has the following groups:- Group 1: Ranalozine
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please elaborate on any prior investigations into Rnalozine?
"Two clinical trials are currently running examining Rnalozine's efficacy and safety. Both of these experiments remain in the earlier stages, with neither reaching Phase 3 yet. Moreover, two sites have been identified for this research - both located in Albuquerque, New mexico."
Answered by AI
Is this a pioneering attempt at treatment?
"Gilead Sciences first funded a trial for Rnalozine in 2012, which involved 20 participants. Subsequently, the drug was approved by N/A and presently two trials are being performed across two cities within one nation."
Answered by AI
How many subjects are engaged with this research study?
"At present, this research venture has ceased accruing new participants. It was first posted on May 1st 2012 and last updated June 1 2015. For those seeking other trials, there are 1070 investigations recruiting patients with ischemia and two studies calling for Rnalozine volunteers."
Answered by AI
Are there still patient openings available for this research trial?
"According to clinicaltrials.gov, this particular medical study is no longer recruiting patients as it was last updated on June 1st 2015. Nevertheless, 1072 other trials are still actively accepting participants at the current moment in time."
Answered by AI
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