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

March 31, 2018 updated by: OBS Pakistan
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 Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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    • Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Reduction in frequency of Angina with Ranolazine
Time Frame: 24 weeks
To determine reduction in frequency of Angina with Ranolazine
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Proportion of participants experiencing an adverse event (AE)
Time Frame: 24 weeks
Proportion of participants experiencing an adverse event (AE)
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2018

Primary Completion (ANTICIPATED)

September 30, 2018

Study Completion (ANTICIPATED)

October 31, 2018

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 31, 2018

First Posted (ACTUAL)

April 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2018

Last Update Submitted That Met QC Criteria

March 31, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Stable Angina

Clinical Trials on Ranolazine

3
Subscribe