Stable Angina Pectoris Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled, Parallel Study to Evaluate the Effects of add-on RANCAD on Exercise Tolerance and Angina Frequency in Patients With Stable Angina Pectoris.
Verified date | April 2017 |
Source | TSH Biopharm Corporation Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A double-blind, randomized, placebo-controlled, parallel study to evaluate the effects of add-on RANCAD on exercise tolerance and angina frequency in patients with stable angina pectoris.
Status | Completed |
Enrollment | 75 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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) 4. Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT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 5. Patients developed exercise-induced ECG ischemiai during two qualifying exercise treadmill testsii. The difference between twoiii tests should be = 20% of the longer test or = 1 minute i. Exercise-induced ECG ischemia is defined as the new development of horizontal or down-sloping ST-segment depression of =1mm at 60-80ms after the J point; if patients with baseline ST depression at rest (<1mm), qualifying ST segment depression is defined as additional ST depression of at least 1 mm below the resting value ii. Exercise treadmill test (ETT) will be performed by Modified Bruce Protocol. iii. Two qualifying tests will be conducted 1 week apart, a 3rd ETT test will be performed = 3 days when differences between previous two qualifying ETTs >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 - Uncontrolled hypertension (defined as SBP > 180 mmHg) Voltage criteria for left ventricular hypertrophy in the absence of repolarization abnormalities will not be exclusion criteria 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Far Eastern Memorial Hospital | New Taipei city | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Shin Kong WuHoSu Memorial Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
Taiwan | Mackay Memorial Hospital | Taipei City | |
Taiwan | Linkou Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
TSH Biopharm Corporation Limited |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ETT performing at last treatment visit (Week 12). | To compare the change from baseline of ETT performing duration between add-on RANCAD and placebo at trough (12 hours after dosing) at Week 12. | Week 12 (not including screening & follow-up period) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01257282 -
Prevalence and Prognostic Value of Unrecognized Myocardial Injury in Stable Coronary Artery Disease (PUMI)
|
N/A | |
Completed |
NCT02029118 -
Acupoint Application in Patients With Stable Angina Pectoris (AASAP)
|
Early Phase 1 | |
Completed |
NCT00763464 -
Coronary Artery Disease (CAD) in Postmenopausal Women
|
N/A | |
Recruiting |
NCT02328898 -
Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
|
Phase 4 | |
Completed |
NCT02339454 -
Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris
|
Phase 3 | |
Completed |
NCT01502943 -
Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index
|
Phase 4 | |
Terminated |
NCT00638326 -
Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity
|
Phase 3 | |
Withdrawn |
NCT02165670 -
BASIC VALIDATE Coronary Stent Registry
|
||
Completed |
NCT01632371 -
Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4
|
Phase 4 | |
Completed |
NCT01363661 -
Effect of Molsidomine on the Endothelial (Internal Layer of Blood Vessels) Dysfunction in Patients With Angina Pectoris
|
Phase 4 | |
Completed |
NCT01293097 -
Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI
|
Phase 4 | |
Completed |
NCT02747329 -
A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT
|
N/A | |
Recruiting |
NCT05347069 -
Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization
|
Phase 4 | |
Recruiting |
NCT04938661 -
Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
|
N/A | |
Not yet recruiting |
NCT03155971 -
PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)
|
N/A | |
Active, not recruiting |
NCT02285322 -
Predictors of Blood Pressure Control and Associations With Cardiovascular Diseases in Individuals With High Blood Pressure: a CALIBER Study
|
N/A | |
Active, not recruiting |
NCT02062021 -
Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease
|
N/A | |
Active, not recruiting |
NCT01947361 -
Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)
|
N/A | |
Active, not recruiting |
NCT01937065 -
Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study
|
N/A | |
Completed |
NCT01669382 -
Angio-Seal® vs. Exo-Seal® for Closure of Arterial Puncture Sites
|
Phase 3 |