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

Phase 4

• Conditions: Chronic Stable Angina
• Interventions: Drug: Ranolazine

• Registration Number: NCT03486561
• Lead Sponsor: OBS Pakistan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-31
• Last Update Submitted: 2018-03-31
• Study Start: 2018-04-01
• Study First Posted: 2018-04-03
• Last Update Posted: 2018-04-03
• Primary Completion: 2018-09-30
• Study Completion: 2018-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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  • Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranolazine	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

Primary Outcome Measures

Name	Time	Method
Efficacy: Reduction in frequency of Angina with Ranolazine	24 weeks	To determine reduction in frequency of Angina with Ranolazine

Secondary Outcome Measures

Name	Time	Method
Safety: Proportion of participants experiencing an adverse event (AE)	24 weeks	Proportion of participants experiencing an adverse event (AE)