Status:
COMPLETED
A TSHRN1201 Sub-study-To Evaluate the Effects of add-on Ranolazine on Exercise Tolerance and Angina Frequency
Lead Sponsor:
TSH Biopharm Corporation Limited
Conditions:
Angina
Eligibility:
All Genders
20+ years
Phase:
NA
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-...
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-...
Eligibility Criteria
Inclusion
- 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- Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 5 days will be qualified for entering this study and performing 1st ETT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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03401502
Start Date
June 7 2018
End Date
March 31 2019
Last Update
April 10 2019
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Zhongzheng Dist, Taiwan, 10048