Trial Outcomes & Findings for Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) (NCT NCT01294462)
NCT ID: NCT01294462
Last Updated: 2014-06-27
Results Overview
Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
801 participants
Primary outcome timeframe
Ongoing up to12 months
Results posted on
2014-06-27
Participant Flow
In total, 817 patients were enrolled from 3 countries (Japan, South Korea and Taiwan). Of the randomised patients, most patients were Japanese (723 \[90.3%\]). The first patient was enrolled on 28 February 2010 and the last patient completed the study on 31 July 2012.
In total, 801 patients (401 in the ticagrelor \[AZD6140 90 mg bd\] group and 400 patients in the clopidogrel \[clopidogrel 75 mg od\] group) were randomised to treatment. The reasons for not being randomised were "Incorrect enrolment before randomisation" and "Patient decision (withdrawal of consent)".
Participant milestones
| Measure |
Ticagrelor (AZD6140)
Ticagrelor (AZD6140) 90 mg bid
|
Clopidogrel
Clopidogrel 75mg od
|
|---|---|---|
|
Overall Study
STARTED
|
401
|
400
|
|
Overall Study
Received Randomized Treatment
|
387
|
380
|
|
Overall Study
COMPLETED
|
335
|
337
|
|
Overall Study
NOT COMPLETED
|
66
|
63
|
Reasons for withdrawal
| Measure |
Ticagrelor (AZD6140)
Ticagrelor (AZD6140) 90 mg bid
|
Clopidogrel
Clopidogrel 75mg od
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
65
|
63
|
Baseline Characteristics
Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
Baseline characteristics by cohort
| Measure |
Ticagrelor (AZD6140)
n=400 Participants
Ticagrelor (AZD6140) 90 mg bid
|
Clopidogrel
n=400 Participants
Clopidogrel 75mg od
|
Total
n=800 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 Years
STANDARD_DEVIATION 12 • n=5 Participants
|
66 Years
STANDARD_DEVIATION 11 • n=7 Participants
|
67 Years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
305 Participants
n=5 Participants
|
307 Participants
n=7 Participants
|
612 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
361 Participants
n=5 Participants
|
360 Participants
n=7 Participants
|
721 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Ongoing up to12 monthsPopulation: Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data
Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Outcome measures
| Measure |
Ticagrelor (AZD6140)
n=387 Participants
Ticagrelor (AZD6140) 90mg bid
|
Clopidogrel
n=380 Participants
Clopidogrel 75mg od
|
|---|---|---|
|
Major Bleeding
|
11.2 Percent probability
|
8.4 Percent probability
|
PRIMARY outcome
Timeframe: Ongoing up to 12 monthsPopulation: Full Analysis set which includes all randomized patients with available post-randomization efficacy data
Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Outcome measures
| Measure |
Ticagrelor (AZD6140)
n=400 Participants
Ticagrelor (AZD6140) 90mg bid
|
Clopidogrel
n=400 Participants
Clopidogrel 75mg od
|
|---|---|---|
|
Major Adverse Cardiac Events (MACE)
|
10.2 Percent probability
|
8.1 Percent probability
|
SECONDARY outcome
Timeframe: Ongoing up to12 monthsPopulation: Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data
Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Outcome measures
| Measure |
Ticagrelor (AZD6140)
n=387 Participants
Ticagrelor (AZD6140) 90mg bid
|
Clopidogrel
n=380 Participants
Clopidogrel 75mg od
|
|---|---|---|
|
Major and Minor Bleeding
|
26.8 Percent probability
|
16.2 Percent probability
|
SECONDARY outcome
Timeframe: Ongoing up to 12 monthsPopulation: Full Analysis set which includes all randomized patients with available post-randomization efficacy data
Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Outcome measures
| Measure |
Ticagrelor (AZD6140)
n=400 Participants
Ticagrelor (AZD6140) 90mg bid
|
Clopidogrel
n=400 Participants
Clopidogrel 75mg od
|
|---|---|---|
|
Composite of All-cause Mortality, MI or Stroke
|
10.5 Percent probability
|
8.1 Percent probability
|
Adverse Events
Ticagrelor (AZD6140)
Serious events: 92 serious events
Other events: 327 other events
Deaths: 0 deaths
Clopidogrel
Serious events: 112 serious events
Other events: 337 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ticagrelor (AZD6140)
n=387 participants at risk
Ticagrelor (AZD6140) 90mg bid
|
Clopidogrel
n=380 participants at risk
Clopidogrel 75mg od
|
|---|---|---|
|
Cardiac disorders
Coronary artery stenosis
|
9.3%
36/387 • Approximately 6 months to 1 year.
|
12.4%
47/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Angina pectoris
|
1.3%
5/387 • Approximately 6 months to 1 year.
|
2.4%
9/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Angina unstable
|
1.0%
4/387 • Approximately 6 months to 1 year.
|
1.3%
5/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.52%
2/387 • Approximately 6 months to 1 year.
|
0.79%
3/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
4/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.78%
3/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Cardiac failure
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.79%
3/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Myocardial infarction
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Pericardial effusion
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
supraventricular tachycardia
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Postinfarction angina
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
coronary artery perforation
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
2.8%
11/387 • Approximately 6 months to 1 year.
|
2.6%
10/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
1.6%
6/387 • Approximately 6 months to 1 year.
|
2.1%
8/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.52%
2/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.52%
2/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
patella fracture
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Cerebral infarction
|
1.0%
4/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Loss of consciousness
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Headache
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Pneumonia
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Herpes Zoster
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Pyelonephritis
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Bacteraemia
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Urinary tract infection
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Groin abscess
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Cellulitis
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
General disorders
Thrombosis in device
|
0.52%
2/387 • Approximately 6 months to 1 year.
|
1.1%
4/380 • Approximately 6 months to 1 year.
|
|
General disorders
Device occlusion
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
General disorders
Chest pain
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
General disorders
Non-cardiac chest pain
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
1.1%
4/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Loose tooth
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Radicular cyst
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.53%
2/380 • Approximately 6 months to 1 year.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Lumber spinal stenosis
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Vascular disorders
Arteriovenous fistula
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Vascular disorders
Aortic stenosis
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Psychiatric disorders
Anxiety
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Congenital, familial and genetic disorders
Anomalous arrangement of pancreaticobiliary duct
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Eye disorders
Cataract
|
0.00%
0/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.26%
1/387 • Approximately 6 months to 1 year.
|
0.00%
0/380 • Approximately 6 months to 1 year.
|
Other adverse events
| Measure |
Ticagrelor (AZD6140)
n=387 participants at risk
Ticagrelor (AZD6140) 90mg bid
|
Clopidogrel
n=380 participants at risk
Clopidogrel 75mg od
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
15.2%
59/387 • Approximately 6 months to 1 year.
|
14.5%
55/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
26/387 • Approximately 6 months to 1 year.
|
6.1%
23/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
21/387 • Approximately 6 months to 1 year.
|
7.1%
27/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Nausea
|
5.4%
21/387 • Approximately 6 months to 1 year.
|
6.8%
26/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.3%
9/387 • Approximately 6 months to 1 year.
|
2.4%
9/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
10/387 • Approximately 6 months to 1 year.
|
0.79%
3/380 • Approximately 6 months to 1 year.
|
|
Gastrointestinal disorders
Dental Caries
|
0.78%
3/387 • Approximately 6 months to 1 year.
|
2.1%
8/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Myocardial infarcion
|
9.0%
35/387 • Approximately 6 months to 1 year.
|
6.1%
23/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Angina pectoris
|
4.1%
16/387 • Approximately 6 months to 1 year.
|
5.8%
22/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Coronary artery stenosis
|
3.6%
14/387 • Approximately 6 months to 1 year.
|
4.5%
17/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Bradycardia
|
2.8%
11/387 • Approximately 6 months to 1 year.
|
2.1%
8/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Cardiac failure
|
2.1%
8/387 • Approximately 6 months to 1 year.
|
2.1%
8/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.1%
8/387 • Approximately 6 months to 1 year.
|
2.1%
8/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.8%
7/387 • Approximately 6 months to 1 year.
|
1.6%
6/380 • Approximately 6 months to 1 year.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
5/387 • Approximately 6 months to 1 year.
|
2.6%
10/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Nasopharyngitis
|
14.2%
55/387 • Approximately 6 months to 1 year.
|
15.5%
59/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
10/387 • Approximately 6 months to 1 year.
|
1.3%
5/380 • Approximately 6 months to 1 year.
|
|
Infections and infestations
Pneumonia
|
2.1%
8/387 • Approximately 6 months to 1 year.
|
0.79%
3/380 • Approximately 6 months to 1 year.
|
|
General disorders
Pyrexia
|
14.5%
56/387 • Approximately 6 months to 1 year.
|
13.4%
51/380 • Approximately 6 months to 1 year.
|
|
General disorders
Non-cardiac chest pain
|
2.1%
8/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
General disorders
Oedema peripheral
|
2.1%
8/387 • Approximately 6 months to 1 year.
|
3.2%
12/380 • Approximately 6 months to 1 year.
|
|
General disorders
Puncture site pain
|
1.6%
6/387 • Approximately 6 months to 1 year.
|
1.8%
7/380 • Approximately 6 months to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
44/387 • Approximately 6 months to 1 year.
|
12.1%
46/380 • Approximately 6 months to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
15/387 • Approximately 6 months to 1 year.
|
2.6%
10/380 • Approximately 6 months to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
11/387 • Approximately 6 months to 1 year.
|
1.6%
6/380 • Approximately 6 months to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
10/387 • Approximately 6 months to 1 year.
|
2.9%
11/380 • Approximately 6 months to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.6%
10/387 • Approximately 6 months to 1 year.
|
2.6%
10/380 • Approximately 6 months to 1 year.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.1%
16/387 • Approximately 6 months to 1 year.
|
2.4%
9/380 • Approximately 6 months to 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
13/387 • Approximately 6 months to 1 year.
|
5.3%
20/380 • Approximately 6 months to 1 year.
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.1%
8/387 • Approximately 6 months to 1 year.
|
2.1%
8/380 • Approximately 6 months to 1 year.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.8%
7/387 • Approximately 6 months to 1 year.
|
1.3%
5/380 • Approximately 6 months to 1 year.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.6%
6/387 • Approximately 6 months to 1 year.
|
2.1%
8/380 • Approximately 6 months to 1 year.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
7/387 • Approximately 6 months to 1 year.
|
2.9%
11/380 • Approximately 6 months to 1 year.
|
|
Psychiatric disorders
Insomnia
|
15.0%
58/387 • Approximately 6 months to 1 year.
|
12.9%
49/380 • Approximately 6 months to 1 year.
|
|
Psychiatric disorders
Restlessness
|
3.6%
14/387 • Approximately 6 months to 1 year.
|
0.79%
3/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Headache
|
8.5%
33/387 • Approximately 6 months to 1 year.
|
15.0%
57/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Dizziness
|
5.7%
22/387 • Approximately 6 months to 1 year.
|
4.7%
18/380 • Approximately 6 months to 1 year.
|
|
Nervous system disorders
Hypoaesthesia
|
1.8%
7/387 • Approximately 6 months to 1 year.
|
3.2%
12/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
3.4%
13/387 • Approximately 6 months to 1 year.
|
3.2%
12/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
10/387 • Approximately 6 months to 1 year.
|
2.1%
8/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.8%
7/387 • Approximately 6 months to 1 year.
|
0.26%
1/380 • Approximately 6 months to 1 year.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
1.6%
6/387 • Approximately 6 months to 1 year.
|
2.4%
9/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
23/387 • Approximately 6 months to 1 year.
|
5.8%
22/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
22/387 • Approximately 6 months to 1 year.
|
2.4%
9/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.1%
8/387 • Approximately 6 months to 1 year.
|
1.1%
4/380 • Approximately 6 months to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.0%
4/387 • Approximately 6 months to 1 year.
|
2.1%
8/380 • Approximately 6 months to 1 year.
|
|
Vascular disorders
Hypertension
|
5.9%
23/387 • Approximately 6 months to 1 year.
|
7.1%
27/380 • Approximately 6 months to 1 year.
|
|
Vascular disorders
Hypotension
|
2.3%
9/387 • Approximately 6 months to 1 year.
|
1.6%
6/380 • Approximately 6 months to 1 year.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.1%
12/387 • Approximately 6 months to 1 year.
|
1.6%
6/380 • Approximately 6 months to 1 year.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.6%
10/387 • Approximately 6 months to 1 year.
|
1.3%
5/380 • Approximately 6 months to 1 year.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.6%
10/387 • Approximately 6 months to 1 year.
|
2.4%
9/380 • Approximately 6 months to 1 year.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
9/387 • Approximately 6 months to 1 year.
|
2.4%
9/380 • Approximately 6 months to 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place