Trial | NCT03486561  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    2000
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.
Study Started
Apr 01
2018
Anticipated
Primary Completion
Sep 30
2018
Anticipated
Study Completion
Oct 31
2018
Anticipated
Last Update
Apr 03
2018

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.

Ranolazine Other

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

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Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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
No Results Posted