Clinical trial NCT03486561: Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine)
Official title: Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Stable Angina
Keywords: Ranolazine
Pakistan
Ischemic Heart Disease
Lead sponsor: OBS Pakistan
Sponsor class: INDUSTRY
First posted: 2018-04-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Labelled Phase IV clinical trial
Primary purpose: TREATMENT

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.


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  * Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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

Primary outcomes:
measure: Efficacy: Reduction in frequency of Angina with Ranolazine
timeFrame: 24 weeks
Secondary outcomes:
measure: Safety: Proportion of participants experiencing an adverse event (AE)
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References: