A TSHRN1201 Sub-study-To Evaluate the Effects of add-on Ranolazine on Exercise Tolerance and Angina Frequency

NCT03401502 | Completed

• 1 other identifier: TSHRN1701
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, randomized, placebo-controlled, and parallel study. The study is comprised of three main phases: a single-blind placebo run-in qualifying phase lasting about 14 days, a double-blind treatment phase of 12 weeks, and a 2-week follow-up phase. Approximately 18 patients will be enrolled and randomly assigned to receive placebo or 1,000 mg of extended-release Ranolazine twice-daily for 12 weeks to reach 14 evaluable patients at the end of the study.

Conditions

Angina

Outcome Measures

Primary Outcomes (1)

• ETT performing duration

  To compare the change from baseline of ETT performing duration between add-on Ranolazine and placebo

  at trough (12 hours after dosing) at Week 12

Study Arms (2)

Treatment groups

EXPERIMENTAL

Ranolazine 1000 mg

Drug: Ranolazine

Control group

PLACEBO COMPARATOR

Placebos

Drug: Placebos

Interventions

Ranolazine DRUG

Oral, b.i.d

Also known as: RNTA

Treatment groups

Placebos DRUG

Oral, b.i.d

Also known as: Placebo

Control group

Eligibility Criteria

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

You may qualify if:

• Male or female patients aged ≥ 20 years old.
• A minimum 3-month history of stable angina.
• Patients with diagnosis of coronary artery disease (CAD) via at least one of the following criteria:
• Angiographic evidence of ≥ 50% stenosis of ≥ 1 major coronary artery;
• CT angiographic evidence of ≥ 50% stenosis of ≥ 1 major coronary artery;
• History of previous myocardial infarction (MI)\*;
• \*Previous MI history of patients has to be occurred and diagnosed at least 2 months prior entering this study.
• A stress-induced reversible perfusion defect identified by radionuclide or echocardiographic imaging.
• Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 5 days will be qualified for entering this study and performing 1st ETT qualifying test.
• Patients developed exercise-induced ECG ischemia during two qualifying exercise treadmill tests. The difference between twotests should be ≤ 20% of the longer test or ≤ 1 minute.
• 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

• TSH Biopharm Corporation Limited: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 10048, Taiwan

Location

MeSH Terms

Conditions

Angina Pectoris

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * Treatment group:Ranolazine 1000 mg: * Control group: Placebo

Study Record Dates

• First Submitted: January 7, 2018
• First Posted: January 17, 2018
• Study Start: June 7, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 31, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)