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

NCT03486561 | Unknown Phase 4

• 1 other identifier: MIDA-OBS-001
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Stable Angina

Keywords

Ranolazine; Pakistan; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Efficacy: Reduction in frequency of Angina with Ranolazine

  To determine reduction in frequency of Angina with Ranolazine

  24 weeks

Secondary Outcomes (1)

• Safety: Proportion of participants experiencing an adverse event (AE)

  24 weeks

Study Arms (1)

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

Drug: Ranolazine

Interventions

Ranolazine DRUG

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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• Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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

You may not qualify if:

• 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

Sponsors & Collaborators

• OBS Pakistan: lead

MeSH Terms

Conditions

Angina, Stable; Myocardial Ischemia

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Angina Pectoris; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Faizan Shaukat

CONTACT

+923328814816; faizan.shaukat@obs.com.pk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Labelled Phase IV clinical trial

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 3, 2018
• Study Start: April 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: October 31, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share