Back to resultsManagement of Ischemic Heart Disease With Angiwell-XR (Ranolazine) (MIDA)
Primary Purpose
Chronic Stable Angina
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ranolazine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stable Angina focused on measuring Ranolazine, Pakistan, Ischemic Heart Disease
Eligibility Criteria
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- Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ranolazine
Arm Description
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
Outcomes
Primary Outcome Measures
Efficacy: Reduction in frequency of Angina with Ranolazine
To determine reduction in frequency of Angina with Ranolazine
Secondary Outcome Measures
Safety: Proportion of participants experiencing an adverse event (AE)
Proportion of participants experiencing an adverse event (AE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03486561
Brief Title
Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine)
Acronym
MIDA
Official Title
Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Anticipated)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
October 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OBS Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The rationale of MIDA trial is to determine efficacy and tolerability of ranolazine molecule among Pakistan population and obtain firsthand knowledge about the molecule ranolazine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina
Keywords
Ranolazine, Pakistan, Ischemic Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open Labelled Phase IV clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranolazine
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy: Reduction in frequency of Angina with Ranolazine
Description
To determine reduction in frequency of Angina with Ranolazine
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Safety: Proportion of participants experiencing an adverse event (AE)
Description
Proportion of participants experiencing an adverse event (AE)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faizan Shaukat
Phone
+923328814816
Email
faizan.shaukat@obs.com.pk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine)
We'll reach out to this number within 24 hrs