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A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the incidence of major cardiovascular events of ticagrelor in Chinese patients with acute coronary syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticargrelor | Experimental | 90 mg/tablet, 1 tablet bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | 90mg/tablet, 1 tablet bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Events | PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal | 12 months |
| Serious Adverse Events Other Than Bleeding | SAEs except the blending events which have aleady been reported as SAEs. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major CV Events | Combination of CV death, MI, and stroke | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Runlin Gao, Doctor | Fu Wai Hospital, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | 100006 | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29488142 | Background | Gao R, Wu Y, Liu H, Su G, Yuan Z, Zhang A, Wang Y, Wang Z, Wang Y, Zhang H, Zheng Y, Liu L, Shen L, Leonsson-Zachrisson M, Han Y; DAYU study investigators. Safety and Incidence of Cardiovascular Events in Chinese Patients with Acute Coronary Syndrome Treated with Ticagrelor: the 12-Month, Phase IV, Multicenter, Single-Arm DAYU Study. Cardiovasc Drugs Ther. 2018 Feb;32(1):47-56. doi: 10.1007/s10557-018-6772-3. |
| Label | URL |
|---|---|
| D5130C00087 Clinical Study Protocol and amendment redacted | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ticargrelor | 90 mg/tablet, 1 tablet bid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Based on the safety population, i.e. all enrolled patients who received at least one dose of Investigational product (IP)
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| ID | Title | Description |
|---|---|---|
| BG000 | Ticargrelor | 90 mg/tablet, 1 tablet bid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bleeding Events | PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal | Posted | Number | Participants | 12 months |
|
|
From day of first dose to the day of last dose + 7 days, up to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ticargrelor | 90 mg/tablet, 1 tablet bid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Leader | AstraZeneca AB | +46 31 7761000 | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Beijing |
| 100029 |
| China |
| Research Site | Beijing | 100037 | China |
| Research Site | Beijing | 100050 | China |
| Research Site | Beijing | 100083 | China |
| Research Site | Beijing | 100730 | China |
| Research Site | Changchun | 130021 | China |
| Research Site | Chengdu | 610041 | China |
| Research Site | Chuangchun | 130041 | China |
| Research Site | Fuzhou | 350001 | China |
| Research Site | Fuzhou | China |
| Research Site | Guangzhou | 510080 | China |
| Research Site | Guangzhou | 510220 | China |
| Research Site | Jinan | 250012 | China |
| Research Site | Jinan | 250021 | China |
| Research Site | Jinan | 250033 | China |
| Research Site | Jining | 272011 | China |
| Research Site | Kunming | 650032 | China |
| Research Site | Nanjing | 210009 | China |
| Research Site | Nanjing | 210012 | China |
| Research Site | Nanjing | 210029 | China |
| Research Site | Shanghai | 200025 | China |
| Research Site | Shanghai | 200433 | China |
| Research Site | Shanghai | China |
| Research Site | Shenyang | 110001 | China |
| Research Site | Shenyang | 110016 | China |
| Research Site | Shenzhen | 518003 | China |
| Research Site | Shenzhen | 518020 | China |
| Research Site | Shenzhen | 518036 | China |
| Research Site | Taiyuan | 030001 | China |
| Research Site | Wuhan | CN-430022 | China |
| Research Site | Wuxi | 214023 | China |
| Research Site | Xi'an | 710032 | China |
| Research Site | Xi'an | 710061 | China |
| Research Site | Xiamen | 361004 | China |
| Research Site | Xuzhou | 221006 | China |
| Research Site | Zhengzhou | 450000 | China |
| Research Site | Zhengzhou | 450012 | China |
| Research Site | Zhongshan | 528403 | China |
| Other |
|
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Ethnic Group | Number | Participants |
|
| Race/Ethnicity, Customized | Race | Number | Participants |
|
|
| Primary | Serious Adverse Events Other Than Bleeding | SAEs except the blending events which have aleady been reported as SAEs. | Posted | Number | Participants | 12 months |
|
|
|
| Secondary | Major CV Events | Combination of CV death, MI, and stroke | Posted | Number | Participants | 12 months |
|
|
|
| 161 |
| 2,001 |
| 230 |
| 2,001 |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastric Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Faeces Discoloured | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastritis Erosive | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gingival Bleeding | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Acute Left Ventricular Failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardiac Failure Chronic | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardiac Failure Acute | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Coronary Artery Thrombosis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sinus Arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ventricular Arrhythmia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ventricular Septal Defect Acquired | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lung Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia Klebsiella | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pulmonary Tuberculosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemorrhage Urinary Tract | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypertensive Nephropathy | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Renal Artery Stenosis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cerebral Haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypoglycaemic Coma | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Intercostal Neuralgia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sudden Death | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Multi-Organ Failure | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bronchitis Chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gouty Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Brain Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Soft Tissue Injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Bronchial Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Metastatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Myeloproliferative Disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Arteriovenous Fistula | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peripheral Venous Disease | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Subclavian Artery Stenosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Liver Disorder | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Completed Suicide | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Aural Polyp | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| Middle Ear Inflammation | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vertigo Positional | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| Primary Hyperaldosteronism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| Thyroid Mass | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| Blindness Unilateral | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cervical Polyp | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
At least sixty (60) days prior to submission of any material for publication or presentation, Institution shall provide AstraZeneca with such material for review. If requested in writing by AstraZeneca, Institution shall withhold material from submission for publication or presentation for an additional ninety (90) days to allow for the filing of a patent application or the taking of such measures as AstraZeneca deems appropriate to establish and preserve its proprietary rights.
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |