Phase
Condition
Coronary Artery Disease
Chest Pain
Acute Pain
Treatment
N/AClinical Study ID
Ages 20-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent.
Males and females between the ages of 20 and 80 years.
Females of childbearing potential must have a negative pregnancy test, not be breastfeeding and established on a method of contraception that in the investigator'sopinion is acceptable. Females must agree to remain on their established method ofcontraception through their participation in the study and for 14 days following thelast dose of study drug.
Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrolment) of myocardial infarction or significantcoronary artery disease with noninvasive or angiographic confirmation.
Symptoms that support the diagnosis of chronic angina and/or a history of an abnormalexercise response limited by angina and/or electrocardiograph (ECG) changes.
Moderate angina pectoris (Class II or III, Grading of Angina Pectoris by the CanadianCardiovascular Society Classification System).
Patient whose symptom-limited Total Exercise Duration (TED) is between 3 to 7 minutesin Exercise Tolerance Test (ETT) on Standard Bruce Protocol, and symptom-limited TEDon two screen examinations (Day -7 and 0) in which the shorter is within 85% of thelonger .
Patient has been on one beta-blocker or on one calcium-channel blocker for at least 14days prior to dosing of study medication and can remain on this treatment throughoutthe study as background anti-anginal treatment. Short-acting nitroglycerin foron-demand use is allowed for all eligible patients.
Understand and be willing, able and likely to comply with all study procedures andrestrictions and comprehends the verbal rating scales and diary cards.
Exclusion
Exclusion Criteria:
With contraindication to, unable to, or with other co-morbidities that may prevent orinterfere with the ability to perform treadmill ETT (including, but not limited to:pulmonary hypertension, functionally limiting COPD (chronic obstructive pulmonarydisease), history of pulmonary tuberculosis, prior hospitalization for acuteexacerbation of chronic lung disease, home oxygen use, chronic oral steroid therapythat can limit exercise capacity, functionally limiting peripheral artery disease,etc.).
Presence of electrocardiographic or other abnormalities/factors that could interferewith exercise electrocardiograph interpretation or may lead to a false positive stresstest (e.g., pre-exercise horizontal or down-sloping ST segment depression in anystandard lead, cardiac glycoside therapy, Lown-Ganong-Levine Syndrome,Wolff-Parkinson-White syndrome (WPW), left bundle branch block, left ventricularhypertrophy with repolarization abnormality, implanted pacemaker, etc.).
Clinically significant arrhythmias or atrioventricular conduction block greater thanfirst degree, decompensated heart failure, atrial fibrillation, hypertrophiccardiomyopathy.
Acute coronary syndrome (acute myocardial infarction or unstable angina) in the prior 2 months or coronary revascularization within the prior 6 months or planned coronaryrevascularization during the study period.
Congenital cardiac defects, ongoing history of decompensated congestive heart failure,severe valvular disease, severe uncontrolled hypertension (seated systolic bloodpressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg), severe anemia,suspected or known dissecting aortic aneurysm, acute myocarditis or pericarditis,thrombophlebitis or pulmonary embolism.
History of bleeding diathesis, cerebral hemorrhage, or seizure disorders that requiredanticonvulsant medication.
Patients requiring the use of long-acting nitroglycerin, ranolazine, and/or multipleanti-anginal drugs.
Aspirin and/or statins started less than 14 days prior to the signing of informedconsent.
Pregnancy or lactation.
Clinical trials/experimental medication 1) Participation in any other clinical trialor receipt of an investigational drug within 30 days prior to the initial visit.
- Previous participation in the studies of T89. 11. Substance abuse. Patients with arecent history (within the last 2 years) of alcoholism or known drug dependence.
- Is a family member or relative of the study site staff. 13. Any other conditions that,in the opinion of the investigator, are likely to prevent compliance with the studyprotocol or pose a safety concern if the subject participates in the study.
Study Design
Study Description
Connect with a study center
Minsk Regional Clinical Hospital
Minsk, 223041
BelarusSite Not Available
Dr. Petr Polasek, MD, Office of
Kelowna, British Columbia V1Y 1V6
CanadaSite Not Available
The Medical Arts Health Research Group
North Vancouver, British Columbia V7L 2P7
CanadaSite Not Available
Victoria Heart Institute Foundation
Victoria, British Columbia V8R 4R2
CanadaSite Not Available
Dixie Medical Group
Mississauga, Ontario L4W 0C2
CanadaSite Not Available
Bakbak Medicine Professional Corporation
Oshawa, Ontario L1H 1B9
CanadaSite Not Available
Heart Care Research
Oshawa, Ontario L1J 2J9
CanadaSite Not Available
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available
ViaCar Recherche Clinique Inc.
Brossard, Quebec J4X 1S4
CanadaSite Not Available
ViaCar Recherche Clinique Inc.
Greenfield Park, Quebec J4V 2G8
CanadaSite Not Available
Centre Cardiovasculaire De La Rive-Sud (Ccrs)
Longueuil, Quebec J4M 2X1
CanadaSite Not Available
Clinique Sante Cardio MC
Montreal, Quebec H1T 3Y7
CanadaSite Not Available
Montreal Heart Institute
Montreal, Quebec H1T 1C8
CanadaSite Not Available
Centre de Sante et de Services Sociaux de Trois-Rivieres
Trois-Rivieres, Quebec G8Z 3R9
CanadaSite Not Available
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Quebec, G1V 4G5
CanadaSite Not Available
The "Unimed Ajara"
Batumi, 6000
GeorgiaSite Not Available
"Clinic L J" Ltd
Tbilisi, 4600
GeorgiaSite Not Available
Archangel St. Michael Multiprofile Clinical Hospital
Tbilisi, 0159
GeorgiaSite Not Available
Cardio-Reanimation Centre
Tbilisi, 0159
GeorgiaSite Not Available
Cardiological CLinic "Guli" Ltd
Tbilisi, 0144
GeorgiaSite Not Available
Center of Vascular and Heart Diseases Ltd.
Tbilisi, 0160
GeorgiaSite Not Available
Emergency Cardiology Center named by Academician G. Chapidze Ltd
Tbilisi, 0159
GeorgiaSite Not Available
Tbilis Heart and vascular clinic Ltd.
Tbilisi, 0159
GeorgiaSite Not Available
Under Contracting
Multiple Citis,
JapanSite Not Available
Consultorio Medico de Especialidad
Tijuana, Baja California 22010
MexicoSite Not Available
Centro para el Desarrollo de la Medicina y Asistencia Médica Especializada SC sede Torreon Coahuila
Torreón, Coahuila 27000
MexicoSite Not Available
Cardiocen de Guadalajara, S.C.
Guadalajara, Jalisco 44160
MexicoSite Not Available
Centro de Investigación Clínica Chapultepec
Morelia, Michoacán 58260
MexicoSite Not Available
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí, SLP 78240
MexicoSite Not Available
Centro para el Desarollo de la Medicina y de Asistencia Medica Esp. S.C.
Culiacan, Sinaloa 80020
MexicoSite Not Available
Hospital de Cardiología de Aguascalientes
Aguascalientes, 20230
MexicoSite Not Available
OSMO
Oaxaca, 68000
MexicoSite Not Available
Regional Buegetary Healthcare Institution "Cardiological Dispensary"
Ivanovslaya, Ivanovslaya Obl. 153012
Russian FederationSite Not Available
State Budgetary Healthcare Institution "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, Russia 630087
Russian FederationSite Not Available
Regional Cardiology Center
Volgograd, Russia 400008
Russian FederationSite Not Available
Smolensk State Medical Academy Of Roszdrav
Smolensk, Smoleskaya oblast 214019
Russian FederationSite Not Available
Federal State Budgetary Institution Research Institution Of Cardiology Of Sibirsky
Tomsk, Tomskaya Obl. 634012
Russian FederationSite Not Available
Ural Medical Academy
Ekaterinburg, 620036
Russian FederationSite Not Available
Nonstate Healthcare Institution "Departmental Clinical Hospital on Kemerovo Station of Public Corporation "Russian Railroad"
Kemerovo, 650055
Russian FederationSite Not Available
Krasnodar regional hospital #1 n.a. Prof. Ochapovskiy S.V.
Krasnodar, 350086
Russian FederationSite Not Available
First Moscow State Medical University
Moscow, 119991
Russian FederationSite Not Available
Moscow State Healthcare Institution, City Clinical Hospital #15
Moscow, 111539
Russian FederationSite Not Available
Almazov Federal Heart, Blood And Endocrinology Centre
Saint-Petersburg, 197341
Russian FederationSite Not Available
Almazov Federal Heart, Blood And Endocrinology Centre
St. Petersburg, 197341
Russian FederationSite Not Available
City Hospital #38 named after Semashko N.A.
St. Petersburg, 196601
Russian FederationSite Not Available
City Polyclinic # 109
St. Petersburg, 192288
Russian FederationSite Not Available
St. Petersburg State Health Care, Institution Pokrovskaya City Hospital
St. Petersburg, 199106
Russian FederationSite Not Available
Tyumen Cardiology Center
Tyumen, 625026
Russian FederationSite Not Available
City Hospital #4
Vladimir, 600020
Russian FederationSite Not Available
Clinical Hospital n.a. N.V. Solovyov
Yaroslavl, 150003
Russian FederationSite Not Available
Department of internal diseases #2
Zaporizhzhya, Zaporizhzhya region 69118
UkraineSite Not Available
Regional medical center of cardiovascular diseases
Zaporizhzhya, Zaporizhzhya region 69005
UkraineSite Not Available
Ivano-Frankivsk Regional Clinical Cardiology Dispensary, department of anesthesiology with intensive care unit
Ivano-Frankivsk, 76018
UkraineSite Not Available
L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine
Kharkiv, 61039
UkraineSite Not Available
L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine, Head of Cardiopulmonology Department Government Institution
Kharkiv, 61039
UkraineSite Not Available
Institute Of Gerontology, Department Of Clinical Physiology And Pathology Of Internal Organs
Kiev, 04114
UkraineSite Not Available
Kyiv Oleksandrivska Clinical Hospital
Kiev, 1601
UkraineSite Not Available
Municipal Clinical Hospital #1
Kiev, 2091
UkraineSite Not Available
National medical university named after O.O.Bogomolets
Kiev, 4050
UkraineSite Not Available
Lviv Regional State Clinical Threatment-and-Diagnostic Cardiology Center
Lviv, 79015
UkraineSite Not Available
City Clinical Hospital No. 3
Odessa, 65014
UkraineSite Not Available
Department of Family Medicine and General Practice of Odessa National Medical University
Odessa, 65010
UkraineSite Not Available
Odessa regional cardiological dispensary
Odessa, 65025
UkraineSite Not Available
District Clinical Hospital Of Station "Uzhgorod", Dgto "Lviv Railway Station" Therapeutic Department
Uzhgorod, 88000
UkraineSite Not Available
City Clinical Hospital # 1
Vinnitsa, 21029
UkraineSite Not Available
Vinnytsya Regional Specialized Center for Radiation Protection of People
Vinnytsya, 21018
UkraineSite Not Available
Cardiology and Medicine Clinic
Little Rock, Arkansas 72204
United StatesSite Not Available
Beaver Medical Clinic
Banning, California 92220
United StatesSite Not Available
Foundation for Cardiovascular Medicine
La Jolla, California 92037
United StatesSite Not Available
Precision Research Institute
National City, California 91950
United StatesSite Not Available
Harbor-UCLA Medical Center
Torrance, California 90509
United StatesSite Not Available
Paradigm Clinical Research Institute, Inc.
Torrance, California 90502
United StatesSite Not Available
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
United StatesSite Not Available
Brevard Cardiovascular Research Associates
Merritt, Florida 32952
United StatesSite Not Available
Integrity Clinical Trials
Miami, Florida 33165
United StatesSite Not Available
Molecular Imaging Research and Clinical Trials
Miami, Florida 33156
United StatesSite Not Available
SouthCoast Research Center, Inc
Miami, Florida 33144
United StatesSite Not Available
NewPhase Clinical Trials, Inc.
Miami Beach, Florida 33140
United StatesSite Not Available
Peninsula Research, Inc.
Ormond Beach, Florida 32174
United StatesSite Not Available
Cardiovascular Center of Sarasota
Sarasota, Florida 34239
United StatesSite Not Available
Jedidiah Clinical Research
Tampa, Florida 33617
United StatesSite Not Available
Athens Heart Center
Athens, Georgia 30606
United StatesSite Not Available
Atlanta Clinical Research Center
Atlanta, Georgia 30342
United StatesSite Not Available
Ellipsis Research
Atlanta, Georgia 30342
United StatesSite Not Available
Central Cardiology
Campbellsville, Kentucky 42718
United StatesSite Not Available
Alexandria Cardiology Clinic
Alexandria, Louisiana 71301
United StatesSite Not Available
Tulane University Health Science Center, Tulane University Heart & Vascular Institute
New Orleans, Louisiana 70112
United StatesSite Not Available
Contract
Multiple Cities, New York
United StatesSite Not Available
Manhattan Medical Research Practice
New York, New York 10016
United StatesSite Not Available
Cleveland Clinic
Medina, Ohio 44256
United StatesSite Not Available
Hillsboro Cardiology, PC
Hillsboro, Oregon 97123
United StatesSite Not Available
Kore CV Research
Jackson, Tennessee 38305
United StatesSite Not Available
Tennessee Center for Clinical Trials
Tullahoma, Tennessee 37388
United StatesSite Not Available
Angiocardiac Care of Texas, PA
Houston, Texas 77025
United StatesSite Not Available
Northwest Houston Cardiology
Houston, Texas 77070
United StatesSite Not Available
Cardiology Center of Houston, PA
Katy, Texas 77450
United StatesSite Not Available
Northwest Heart Center
Tomball, Texas 77375
United StatesSite Not Available
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