Trial Outcomes & Findings for Brilinta DaYu Study (NCT NCT01870921)
NCT ID: NCT01870921
Last Updated: 2018-04-03
Results Overview
PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2004 participants
Primary outcome timeframe
12 months
Results posted on
2018-04-03
Participant Flow
Participant milestones
| Measure |
Ticargrelor
90 mg/tablet, 1 tablet bid
|
|---|---|
|
Overall Study
STARTED
|
2004
|
|
Overall Study
COMPLETED
|
1914
|
|
Overall Study
NOT COMPLETED
|
90
|
Reasons for withdrawal
| Measure |
Ticargrelor
90 mg/tablet, 1 tablet bid
|
|---|---|
|
Overall Study
Subject decision
|
80
|
|
Overall Study
Severe non-compliance to protocol
|
7
|
|
Overall Study
Subject Lost to Follow up
|
2
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Brilinta DaYu Study
Baseline characteristics by cohort
| Measure |
Ticargrelor
n=2001 Participants
90 mg/tablet, 1 tablet bid
|
|---|---|
|
Age, Continuous
|
59.3 Years
STANDARD_DEVIATION 10.83 • n=39 Participants
|
|
Age, Customized
< 75 years
|
1854 Participants
n=39 Participants
|
|
Age, Customized
>= 75 years
|
147 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
422 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1579 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Hispanic or latino
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Not hispanic or latino
|
2001 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2001 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal
Outcome measures
| Measure |
Ticargrelor
n=2001 Participants
90 mg/tablet, 1 tablet bid
|
|---|---|
|
Bleeding Events
Fatal/life threatening
|
17 Participants
|
|
Bleeding Events
Major
|
27 Participants
|
|
Bleeding Events
Major + minor
|
93 Participants
|
|
Bleeding Events
Major + minor + minimal
|
426 Participants
|
PRIMARY outcome
Timeframe: 12 monthsSAEs except the blending events which have aleady been reported as SAEs.
Outcome measures
| Measure |
Ticargrelor
n=2001 Participants
90 mg/tablet, 1 tablet bid
|
|---|---|
|
Serious Adverse Events Other Than Bleeding
|
116 Participants
|
SECONDARY outcome
Timeframe: 12 monthsCombination of CV death, MI, and stroke
Outcome measures
| Measure |
Ticargrelor
n=2001 Participants
90 mg/tablet, 1 tablet bid
|
|---|---|
|
Major CV Events
|
85 Participants
|
Adverse Events
Ticargrelor
Serious events: 161 serious events
Other events: 230 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ticargrelor
n=2001 participants at risk
90 mg/tablet, 1 tablet bid
|
|---|---|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.80%
16/2001 • Number of events 16 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.60%
12/2001 • Number of events 12 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
4/2001 • Number of events 5 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.15%
3/2001 • Number of events 3 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Cardiac Failure
|
0.25%
5/2001 • Number of events 5 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.15%
3/2001 • Number of events 3 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.15%
3/2001 • Number of events 3 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Angina Pectoris
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Angina Unstable
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Arrhythmia
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Coronary Artery Thrombosis
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Palpitations
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Pericardial Effusion
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Sinus Arrest
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Cardiac disorders
Ventricular Septal Defect Acquired
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Lung Infection
|
0.20%
4/2001 • Number of events 4 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Pneumonia
|
0.15%
3/2001 • Number of events 3 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Appendicitis
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Urinary Tract Infection
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Cystitis
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Gastroenteritis
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Pneumonia Klebsiella
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Septic Shock
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.20%
4/2001 • Number of events 4 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Renal and urinary disorders
Haematuria
|
0.20%
4/2001 • Number of events 4 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Renal and urinary disorders
Haemorrhage Urinary Tract
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Renal and urinary disorders
Hypertensive Nephropathy
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Renal and urinary disorders
Proteinuria
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Renal and urinary disorders
Renal Failure
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.20%
4/2001 • Number of events 4 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.15%
3/2001 • Number of events 3 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Nervous system disorders
Cerebral Infarction
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Nervous system disorders
Hypoglycaemic Coma
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Nervous system disorders
Syncope
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
General disorders
Chest Discomfort
|
0.30%
6/2001 • Number of events 6 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
General disorders
Sudden Death
|
0.15%
3/2001 • Number of events 3 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
General disorders
Multi-Organ Failure
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.20%
4/2001 • Number of events 4 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Injury, poisoning and procedural complications
Brain Contusion
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Injury, poisoning and procedural complications
Injury
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.20%
4/2001 • Number of events 5 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Metabolism and nutrition disorders
Gout
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative Disorder
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Vascular disorders
Arteriovenous Fistula
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Vascular disorders
Hypertension
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Vascular disorders
Peripheral Venous Disease
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Vascular disorders
Subclavian Artery Stenosis
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Hepatobiliary disorders
Liver Disorder
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Psychiatric disorders
Depression
|
0.10%
2/2001 • Number of events 2 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Psychiatric disorders
Completed Suicide
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Ear and labyrinth disorders
Aural Polyp
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Ear and labyrinth disorders
Middle Ear Inflammation
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Endocrine disorders
Primary Hyperaldosteronism
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Endocrine disorders
Thyroid Mass
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Eye disorders
Blindness Unilateral
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Eye disorders
Cataract
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Reproductive system and breast disorders
Cervical Polyp
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Investigations
Blood Glucose Increased
|
0.05%
1/2001 • Number of events 1 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
Other adverse events
| Measure |
Ticargrelor
n=2001 participants at risk
90 mg/tablet, 1 tablet bid
|
|---|---|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.6%
113/2001 • Number of events 130 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.5%
130/2001 • Number of events 132 • From day of first dose to the day of last dose + 7 days, up to 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER