MIDA: Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine)

Sponsor

OBS Pakistan (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03486561

Collaborator

(none)

2,000

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Stable Angina	Drug: Ranolazine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open Labelled Phase IV clinical trialOpen Labelled Phase IV clinical trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine)

Anticipated Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Sep 30, 2018

Anticipated Study Completion Date :

Oct 31, 2018

Arms and Interventions

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	Drug: Ranolazine 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.

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

Drug: Ranolazine

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.

Outcome Measures

Primary Outcome Measures

Efficacy: Reduction in frequency of Angina with Ranolazine [24 weeks]
To determine reduction in frequency of Angina with Ranolazine

Secondary Outcome Measures

Safety: Proportion of participants experiencing an adverse event (AE) [24 weeks]
Proportion of participants experiencing an adverse event (AE)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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