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

NCT ID: NCT03401502

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-07
• Study Completion Date: 2019-03-31

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.

Detailed Description

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.

Patients with chronic angina pectoris will be screened for eligibility after providing informed consent. Patients present with the symptoms of stable angina after withdrawn from other antianginal agents and given the required background therapy for at least 5 days will be qualified for entering this study and performing 1st ETT qualifying test.

Conditions

Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment groups

Ranolazine 1000 mg

Group Type: EXPERIMENTAL

Ranolazine

Intervention Type: DRUG

Oral, b.i.d

Control group

Placebos

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Oral, b.i.d

Interventions

Ranolazine

Oral, b.i.d

Intervention Type: DRUG

Placebos

Oral, b.i.d

Intervention Type: DRUG

Other Intervention Names

RNTA; Placebo

Eligibility Criteria

Inclusion Criteria

1. Male or female patients aged ≥ 20 years old.

2. A minimum 3-month history of stable angina.

3. 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.

4. 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.

5. 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.

6. Willing and able to provide a written informed consent.

Exclusion Criteria

1. 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.

2. Patients with family history of (or congenital) long QT syndrome.

3. Patients with congenital heart disease.

4. Patients with uncorrected valvular heart disease.

5. Patients with unstable angina, or MI, or coronary revascularization procedure ≤ 2 months prior enter this study.

6. 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.

7. 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;

8. Use of any investigational product ≤ 4 weeks prior to screening.

9. Patients with severe hepatic disease (e.g., liver cirrhosis).

10. Patients with impaired renal function (defined as serum Cr >1.5 mg/dl).

11. Patients with any condition or disease which is considered not suitable for this study by investigator.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TSH Biopharm Corporation Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, Zhongzheng Dist, Taiwan

Countries

Taiwan

Other Identifiers

TSHRN1701

Identifier Type: -

Identifier Source: org_study_id