- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03486561
Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine) (MIDA)
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Faizan Shaukat
- Phone Number: +923328814816
- Email: faizan.shaukat@obs.com.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with diagnosis of coronary artery disease (CAD)
- Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT qualifying test
- Patients developed exercise-induced ECG ischemiai during two qualifying exercise treadmill testsii.
- Willing and able to provide a written informed consent
Exclusion Criteria:
• Factors that might compromise ECG or ETT interpretation
- Patients with resting ST-segment depression ≥ 1mm in any lead
- Left bundle-branch block
- Patients implanted with pacemaker
Patients under Digitalis therapy
- Patients with family history of (or congenital) long QT syndrome
- Patients with congenital heart disease
- Patients with uncorrected valvular heart disease
- Patients with unstable angina, or MI, or coronary revascularization procedure ≤ 2 months prior enter this study
- Female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential* who is not using medically recognized method of contraception
*Other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal.
• Patients are under any one of the following conditions:
- New York Heart Association (NYHA) Class III or Class IV congestive heart failure (CHF)
- QTc > 450 msec at screening
- Active myocarditis, pericarditis, hypertrophic cardiomyopathy
Uncontrolled hypertension (defined as SBP > 180 mmHg) Voltage criteria for left ventricular hypertrophy in the absence of repolarization abnormalities will not be exclusion criteria
- Use of any investigational product ≤ 4 weeks prior to screening
- Patients with severe hepatic disease (e.g., liver cirrhosis)
- Patients with impaired renal function (defined as serum Cr >1.5 mg/dl)
- Patients with any condition or disease which is considered not suitable for this study by investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Ranolazine
Ranolazine was approved by the U.S. Food and Drug Administration in 2006 in 500 mg and 1000 mg extended-release doses, advising 500 mg BID as a starting dose and 1000 mg BID as maximum dose
|
Ranolazine inhibits sodium and potassium ion channel currents.
Inhibition of the late phase of the inward sodium current during cardiac repolarization has been well studied4.
In disease states, enhanced sodium-calcium exchange due to augmented late phase of the inward sodium current activity leads to increased cytosolic calcium concentration.
Intracellular calcium overload is believed to be critical to the mechanism of decreased left ventricular relaxation caused by ischemia and reperfusion.
Elevated left ventricular diastolic wall tension compromises myocardial blood flow even further.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: Reduction in frequency of Angina with Ranolazine
Time Frame: 24 weeks
|
To determine reduction in frequency of Angina with Ranolazine
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: Proportion of participants experiencing an adverse event (AE)
Time Frame: 24 weeks
|
Proportion of participants experiencing an adverse event (AE)
|
24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Coronary Disease
- Chest Pain
- Angina Pectoris
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Angina, Stable
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Sodium Channel Blockers
- Ranolazine
Other Study ID Numbers
- MIDA-OBS-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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