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

Chronic Stable Angina Clinical Trial

— MIDA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03486561
• Other study ID #: MIDA-OBS-001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 15, 2018
• Last updated: March 31, 2018
• Start date: April 1, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: March 2018
• Source: OBS Pakistan
• Contact: Faizan Shaukat
• Phone: +923328814816
• Email: faizan.shaukat[@]obs.com.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: October 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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• Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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

Related Conditions & MeSH terms

• Angina, Stable
• Chronic Stable Angina
• Coronary Artery Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OBS Pakistan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Reduction in frequency of Angina with Ranolazine	To determine reduction in frequency of Angina with Ranolazine	24 weeks
Secondary	Safety: Proportion of participants experiencing an adverse event (AE)	Proportion of participants experiencing an adverse event (AE)	24 weeks