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)

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01294462
• Collaborator: (none)
• Enrollment: 801
• Locations: 94
• Arms: 2
• Duration (Months): 17
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI).

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; Percutaneous Coronary Intervention	Drug: Ticagrelor; Drug: Clopidogrel; Drug: Acetylsalicylic acid ASA	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 801 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Double-dummy, Parallel Group, International (Asian), Multicenter, Phase 3 Study to Assess Safety and Efficacy of AZD6140 on Top of Low Dose Acetyl Salicylic Acid (ASA) Versus Clopidogrel on Top of Low Dose ASA in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes(ACS) for Whom PCI is Planned
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Ticagrelor (AZD6140)	Drug: Ticagrelor; 90 mg, oral dose twice daily; Other Names: AZD6140 ; Drug: Acetylsalicylic acid ASA; Low Dose ASA
Active Comparator: 2 Clopidogrel	Drug: Clopidogrel; 75 mg, oral dose once daily; Other Names: Plavix ; Drug: Acetylsalicylic acid ASA; Low Dose ASA

Outcome Measures

Primary Outcome Measures

1. Major Bleeding [Ongoing up to12 months]

   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.

2. Major Adverse Cardiac Events (MACE) [Ongoing up to 12 months]

   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.

Secondary Outcome Measures

1. Major and Minor Bleeding [Ongoing up to12 months]

   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.

2. Composite of All-cause Mortality, MI or Stroke [Ongoing up to 12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Provision of signed informed consent

• Index event of non-ST or ST segment elevation ACS

Exclusion Criteria:

• Index event is an acute complication of percutaneous coronary intervention

• Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment

• Oral anticoagulation therapy that cannot be stopped

• The conditions associated with increased risk of bradycardiac events

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Ichinomiya-shi	Aichi	Japan
2	Research Site	Nagoya-shi	Aichi	Japan
3	Research Site	Okazaki-shi	Aichi	Japan
4	Research Site	Toyohashi-shi	Aichi	Japan
5	Research Site	Toyota-shi	Aichi	Japan
6	Research Site	Akita-shi	Akita	Japan
7	Research Site	Ichihara-shi	Chiba	Japan
8	Research Site	Kamogawa-shi	Chiba	Japan
9	Research Site	Kisarazu-shi	Chiba	Japan
10	Research Site	Matsuyama	Ehime	Japan
11	Research Site	Fukui-shi	Fukui	Japan
12	Research Site	Fukuoka-shi	Fukuoka	Japan
13	Research Site	Kasuya-gun	Fukuoka	Japan
14	Research Site	Kurume	Fukuoka	Japan
15	Research Site	Gifu-shi	Gifu	Japan
16	Research Site	Isesaki	Gunma	Japan
17	Research Site	Maebashi	Gunma	Japan
18	Research Site	Takasaki-shi	Gunma	Japan
19	Research Site	Kure	Hiroshima	Japan
20	Research Site	Sapporo-shi	Hokkaido	Japan
21	Research Site	Sapporo	Hokkaido	Japan
22	Research Site	Akashi-shi	Hyogo	Japan
23	Research Site	Amagasaki-shi	Hyogo	Japan
24	Research Site	Kawanishi-shi	Hyogo	Japan
25	Research Site	Kobe-shi	Hyogo	Japan
26	Research Site	Kobe	Hyogo	Japan
27	Research Site	Nishinomiya	Hyogo	Japan
28	Research Site	Takarazuka-shi	Hyogo	Japan
29	Research Site	Higashiibaragi-gun	Ibaragi	Japan
30	Research Site	Sashima-gun	Ibaragi	Japan
31	Research Site	Hakusan-shi	Ishikawa	Japan
32	Research Site	Kanazawa-shi	Ishikawa	Japan
33	Research Site	Kanazawa	Ishikawa	Japan
34	Research Site	Sakaide-shi	Kagawa	Japan
35	Research Site	Atsugi-shi	Kanagawa	Japan
36	Research Site	Isehara	Kanagawa	Japan
37	Research Site	Kamakura-shi	Kanagawa	Japan
38	Research Site	Kawasaki-shi	Kanagawa	Japan
39	Research Site	Sagamihara-shi	Kanagawa	Japan
40	Research Site	Yamato-shi	Kanagawa	Japan
41	Research Site	Yokohama-shi	Kanagawa	Japan
42	Research Site	Nankoku-shi	Kochi	Japan
43	Research Site	Kumamoto-shi	Kumamoto	Japan
44	Research Site	Yatsushiro-city	Kumamoto	Japan
45	Research Site	Kyoto-shi	Kyoto	Japan
46	Research Site	Sendai-shi	Miyagi	Japan
47	Research Site	Azumino-shi	Nagano	Japan
48	Research Site	Ueda-shi	Nagano	Japan
49	Research Site	Nagasaki-shi	Nagasaki	Japan
50	Research Site	Kurashiki	Okayama	Japan
51	Research Site	Okayama-shi	Okayama	Japan
52	Research Site	Hirakata	Osaka	Japan
53	Research Site	Kawachinagano-shi	Osaka	Japan
54	Research Site	Osaka-shi	Osaka	Japan
55	Research Site	Sakai-shi	Osaka	Japan
56	Research Site	Saga-shi	Saga	Japan
57	Research Site	Ageo-shi	Saitama	Japan
58	Research Site	Hidaka	Saitama	Japan
59	Research Site	Sayama-shi	Saitama	Japan
60	Research Site	Kusatsu-shi	Shiga	Japan
61	Research Site	Moriyama	Shiga	Japan
62	Research Site	Matsue	Shimane	Japan
63	Research Site	Hamamatsu-shi	Shizuoka	Japan
64	Research Site	Izunokuni	Shizuoka	Japan
65	Research Site	Shimada-shi	Shizuoka	Japan
66	Research Site	Sunto-gun	Shizuoka	Japan
67	Research Site	Komatsushima-shi	Tokushima	Japan
68	Research Site	Tokushima-shi	Tokushima	Japan
69	Research Site	Adachi-ku	Tokyo	Japan
70	Research Site	Bunkyo-ku	Tokyo	Japan
71	Research Site	Bunkyo	Tokyo	Japan
72	Research Site	Chiyoda-ku	Tokyo	Japan
73	Research Site	Itabashi-ku	Tokyo	Japan
74	Research Site	Meguro	Tokyo	Japan
75	Research Site	Ome-shi	Tokyo	Japan
76	Research Site	Shinagawa-ku	Tokyo	Japan
77	Research Site	Shinjuku	Tokyo	Japan
78	Research Site	Suginami-ku	Tokyo	Japan
79	Research Site	Tanabe-shi	Wakayama	Japan
80	Research Site	Chuo-shi	Yamanashi	Japan
81	Research Site	Fukuoka		Japan
82	Research Site	Gifu		Japan
83	Research Site	Kumamoto		Japan
84	Research Site	Oita		Japan
85	Research Site	Saga		Japan
86	Research Site	Wakayama		Japan
87	Research Site	Cheonan	Chungcheongnam-do	Korea, Republic of
88	Research Site	Daejeon		Korea, Republic of
89	Research Site	Incheon		Korea, Republic of
90	Research Site	Seoul		Korea, Republic of
91	Research Site	Niao-song-shiang	Kaohsiung	Taiwan
92	Research Site	Kweishan Shiang	Taoyuan Hsien	Taiwan
93	Research Site	Taichung		Taiwan
94	Research Site	Taipei		Taiwan

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Judith Hsia, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• CSR-D5130C00027.pdf

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01294462
• Other Study ID Numbers: D5130C00027
• First Posted: Feb 11, 2011
• Last Update Posted: Jun 27, 2014
• Last Verified: May 1, 2014

• Keywords provided by AstraZeneca: acute coronary syndrome; coronary disease; coronary artery disease
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome; Aspirin; Clopidogrel; Ticagrelor

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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)".

Arm/Group Title	Ticagrelor (AZD6140)	Clopidogrel
Arm/Group Description	Ticagrelor (AZD6140) 90 mg bid	Clopidogrel 75mg od
Period Title: Overall Study
STARTED	401	400
Received Randomized Treatment	387	380
COMPLETED	335	337
NOT COMPLETED	66	63

Baseline Characteristics

Arm/Group Title	Ticagrelor (AZD6140)	Clopidogrel	Total
Arm/Group Description	Ticagrelor (AZD6140) 90 mg bid	Clopidogrel 75mg od	Total of all reporting groups
Overall Participants	400	400	800
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67 (12)	66 (11)	67 (11)
Sex: Female, Male (Count of Participants)
Female	95 23.8%	93 23.3%	188 23.5%
Male	305 76.3%	307 76.8%	612 76.5%
Race/Ethnicity, Customized (Number) [Number]
Chinese	16 4%	19 4.8%	35 4.4%
Japanese	361 90.3%	360 90%	721 90.1%
Korean	23 5.8%	21 5.3%	44 5.5%

Outcome Measures

1. Primary Outcome

Title	Major Bleeding
Description	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.
Time Frame	Ongoing up to12 months

Outcome Measure Data

Analysis Population Description

Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data

Arm/Group Title	Ticagrelor (AZD6140)	Clopidogrel
Arm/Group Description	Ticagrelor (AZD6140) 90mg bid	Clopidogrel 75mg od
Measure Participants	387	380
Number [Percent probability]	11.2	8.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor (AZD6140), Clopidogrel
	Comments	No formal statistical comparison.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.54
	Confidence Interval	(2-Sided) 95%; 0.94 to 2.53
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ticagrelor/Placebo

2. Primary Outcome

Title	Major Adverse Cardiac Events (MACE)
Description	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.
Time Frame	Ongoing up to 12 months

Outcome Measure Data

Analysis Population Description

Full Analysis set which includes all randomized patients with available post-randomization efficacy data

Arm/Group Title	Ticagrelor (AZD6140)	Clopidogrel
Arm/Group Description	Ticagrelor (AZD6140) 90mg bid	Clopidogrel 75mg od
Measure Participants	400	400
Number [Percent probability]	10.2	8.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor (AZD6140), Clopidogrel
	Comments	No formal statistical comparison based on hypothesis test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.47
	Confidence Interval	(2-Sided) 95%; 0.88 to 2.44
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ticagrelor/Placebo

3. Secondary Outcome

Title	Major and Minor Bleeding
Description	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.
Time Frame	Ongoing up to12 months

Outcome Measure Data

Analysis Population Description

Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data

Arm/Group Title	Ticagrelor (AZD6140)	Clopidogrel
Arm/Group Description	Ticagrelor (AZD6140) 90mg bid	Clopidogrel 75mg od
Measure Participants	387	380
Number [Percent probability]	26.8	16.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor (AZD6140), Clopidogrel
	Comments	No formal statistical comparison.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.72
	Confidence Interval	(2-Sided) 95%; 1.23 to 2.40
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ticagrelor/Placebo

4. Secondary Outcome

Title	Composite of All-cause Mortality, MI or Stroke
Description	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.
Time Frame	Ongoing up to 12 months

Outcome Measure Data

Analysis Population Description

Full Analysis set which includes all randomized patients with available post-randomization efficacy data

Arm/Group Title	Ticagrelor (AZD6140)	Clopidogrel
Arm/Group Description	Ticagrelor (AZD6140) 90mg bid	Clopidogrel 75mg od
Measure Participants	400	400
Number [Percent probability]	10.5	8.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ticagrelor (AZD6140), Clopidogrel
	Comments	No formal statistical comparison based on hypothesis test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.51
	Confidence Interval	(2-Sided) 95%; 0.91 to 2.50
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ticagrelor/Placebo

Adverse Events

Time Frame	Approximately 6 months to 1 year.
Arm/Group Title	Ticagrelor (AZD6140)		Clopidogrel
Arm/Group Description	Ticagrelor (AZD6140) 90mg bid		Clopidogrel 75mg od
All Cause Mortality
	Ticagrelor (AZD6140)		Clopidogrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ticagrelor (AZD6140)		Clopidogrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	92/387 (23.8%)		112/380 (29.5%)
Blood and lymphatic system disorders
Disseminated intravascular coagulation	0/387 (0%)		1/380 (0.3%)
Thrombocytopenia	0/387 (0%)		1/380 (0.3%)
Cardiac disorders
Coronary artery stenosis	36/387 (9.3%)		47/380 (12.4%)
Angina pectoris	5/387 (1.3%)		9/380 (2.4%)
Angina unstable	4/387 (1%)		5/380 (1.3%)
Myocardial ischaemia	2/387 (0.5%)		3/380 (0.8%)
Acute myocardial infarction	4/387 (1%)		2/380 (0.5%)
Ventricular fibrillation	3/387 (0.8%)		1/380 (0.3%)
Cardiac failure	1/387 (0.3%)		3/380 (0.8%)
Cardiac failure congestive	1/387 (0.3%)		2/380 (0.5%)
Atrial fibrillation	1/387 (0.3%)		1/380 (0.3%)
Myocardial infarction	1/387 (0.3%)		1/380 (0.3%)
Cardiac failure chronic	1/387 (0.3%)		0/380 (0%)
Pericardial effusion	1/387 (0.3%)		0/380 (0%)
supraventricular tachycardia	1/387 (0.3%)		0/380 (0%)
Postinfarction angina	1/387 (0.3%)		0/380 (0%)
Pulseless electrical activity	1/387 (0.3%)		0/380 (0%)
Prinzmetal angina	0/387 (0%)		2/380 (0.5%)
Cardiac tamponade	0/387 (0%)		1/380 (0.3%)
Myocarditis	0/387 (0%)		1/380 (0.3%)
Pericarditis	0/387 (0%)		1/380 (0.3%)
Sinus arrest	0/387 (0%)		1/380 (0.3%)
Coronary artery dissection	0/387 (0%)		1/380 (0.3%)
coronary artery perforation	0/387 (0%)		1/380 (0.3%)
Congenital, familial and genetic disorders
Anomalous arrangement of pancreaticobiliary duct	0/387 (0%)		1/380 (0.3%)
Ear and labyrinth disorders
Vertigo	1/387 (0.3%)		0/380 (0%)
Sudden hearing loss	1/387 (0.3%)		0/380 (0%)
Eye disorders
Cataract	0/387 (0%)		1/380 (0.3%)
Gastrointestinal disorders
Colonic polyp	1/387 (0.3%)		1/380 (0.3%)
Loose tooth	1/387 (0.3%)		0/380 (0%)
Diarrhoea	0/387 (0%)		1/380 (0.3%)
Enterocolitis	0/387 (0%)		1/380 (0.3%)
Radicular cyst	0/387 (0%)		1/380 (0.3%)
Vomiting	0/387 (0%)		1/380 (0.3%)
Mechanical ileus	1/387 (0.3%)		0/380 (0%)
General disorders
Thrombosis in device	2/387 (0.5%)		4/380 (1.1%)
Device occlusion	1/387 (0.3%)		1/380 (0.3%)
Chest pain	1/387 (0.3%)		0/380 (0%)
Non-cardiac chest pain	1/387 (0.3%)		0/380 (0%)
Hepatobiliary disorders
Cholecystitis acute	1/387 (0.3%)		1/380 (0.3%)
Hepatic function abnormal	0/387 (0%)		1/380 (0.3%)
Cholecystitis	0/387 (0%)		1/380 (0.3%)
Infections and infestations
Pneumonia	1/387 (0.3%)		2/380 (0.5%)
Upper respiratory tract infection	1/387 (0.3%)		2/380 (0.5%)
Herpes Zoster	1/387 (0.3%)		2/380 (0.5%)
Pyelonephritis	1/387 (0.3%)		1/380 (0.3%)
Bacteraemia	1/387 (0.3%)		0/380 (0%)
Urinary tract infection	1/387 (0.3%)		0/380 (0%)
Groin abscess	1/387 (0.3%)		0/380 (0%)
Pneumonia cryptococcal	1/387 (0.3%)		0/380 (0%)
Appendicitis	0/387 (0%)		1/380 (0.3%)
Hepatitis C	0/387 (0%)		1/380 (0.3%)
Otitis media acute	0/387 (0%)		1/380 (0.3%)
Cellulitis	1/387 (0.3%)		0/380 (0%)
Injury, poisoning and procedural complications
In-stent coronary artery restenosis	11/387 (2.8%)		10/380 (2.6%)
Coronary artery restenosis	6/387 (1.6%)		8/380 (2.1%)
Spinal compression fracture	2/387 (0.5%)		1/380 (0.3%)
In-stent arterial restenosis	2/387 (0.5%)		1/380 (0.3%)
patella fracture	1/387 (0.3%)		0/380 (0%)
Tibia fracture	1/387 (0.3%)		0/380 (0%)
Post procedural myocardial infarction	1/387 (0.3%)		0/380 (0%)
Fat embolism	0/387 (0%)		1/380 (0.3%)
Incisional hernia	0/387 (0%)		1/380 (0.3%)
Radius fracture	0/387 (0%)		1/380 (0.3%)
Metabolism and nutrition disorders
Hypovolaemia	1/387 (0.3%)		0/380 (0%)
Decreased appetite	1/387 (0.3%)		0/380 (0%)
Hypoglycaemia	0/387 (0%)		2/380 (0.5%)
Gout	0/387 (0%)		1/380 (0.3%)
Acidosis	1/387 (0.3%)		0/380 (0%)
Diabetes mellitus inadequate control	1/387 (0.3%)		0/380 (0%)
Hyperkalaemia	1/387 (0.3%)		0/380 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/387 (0.3%)		0/380 (0%)
Lumber spinal stenosis	1/387 (0.3%)		0/380 (0%)
Spinal column stenosis	0/387 (0%)		1/380 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	1/387 (0.3%)		1/380 (0.3%)
Neuroma	1/387 (0.3%)		0/380 (0%)
Bladder cancer	0/387 (0%)		2/380 (0.5%)
Gastric cancer	0/387 (0%)		1/380 (0.3%)
Metastases to lymph nodes	0/387 (0%)		1/380 (0.3%)
Colon adenoma	0/387 (0%)		1/380 (0.3%)
Breast cancer female	0/387 (0%)		1/380 (0.3%)
Nervous system disorders
Cerebral infarction	4/387 (1%)		2/380 (0.5%)
Hypoaesthesia	0/387 (0%)		1/380 (0.3%)
Loss of consciousness	1/387 (0.3%)		0/380 (0%)
Spondylitic myelopathy	1/387 (0.3%)		0/380 (0%)
Transient ischaemic attack	1/387 (0.3%)		0/380 (0%)
Intercostal neuralgia	1/387 (0.3%)		0/380 (0%)
Cerebrovascular accident	0/387 (0%)		1/380 (0.3%)
Embolic stroke	0/387 (0%)		1/380 (0.3%)
Headache	0/387 (0%)		1/380 (0.3%)
Parkinson's disease	0/387 (0%)		1/380 (0.3%)
Brain stem stroke	0/387 (0%)		1/380 (0.3%)
Metabolic encephalopathy	1/387 (0.3%)		0/380 (0%)
Psychiatric disorders
Anxiety	1/387 (0.3%)		0/380 (0%)
Anxiety disorder	0/387 (0%)		1/380 (0.3%)
Renal and urinary disorders
Nephrolithiasis	1/387 (0.3%)		0/380 (0%)
Ureteric stenosis	1/387 (0.3%)		0/380 (0%)
Renal failure chronic	0/387 (0%)		2/380 (0.5%)
Renal artery stenosis	0/387 (0%)		1/380 (0.3%)
Renal failure acute	0/387 (0%)		1/380 (0.3%)
Reproductive system and breast disorders
Prostatitis	1/387 (0.3%)		0/380 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/387 (0.3%)		0/380 (0%)
Hyperventilation	1/387 (0.3%)		0/380 (0%)
Pulmonary oedema	1/387 (0.3%)		0/380 (0%)
Sleep apnoea syndrome	0/387 (0%)		4/380 (1.1%)
Pneumonia aspiration	0/387 (0%)		2/380 (0.5%)
Interstitial lung disease	0/387 (0%)		1/380 (0.3%)
Chronic obstructive pulmonary disease	1/387 (0.3%)		1/380 (0.3%)
Skin and subcutaneous tissue disorders
Skin mass	1/387 (0.3%)		0/380 (0%)
Vascular disorders
Arteriovenous fistula	1/387 (0.3%)		0/380 (0%)
Aortic dissection	0/387 (0%)		1/380 (0.3%)
Thrombosis	0/387 (0%)		1/380 (0.3%)
Femoral artery occlusion	0/387 (0%)		1/380 (0.3%)
Peripheral arterial occlusive disease	0/387 (0%)		1/380 (0.3%)
Aortic stenosis	1/387 (0.3%)		0/380 (0%)
Other (Not Including Serious) Adverse Events
	Ticagrelor (AZD6140)		Clopidogrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	327/387 (84.5%)		337/380 (88.7%)
Blood and lymphatic system disorders
Anaemia	9/387 (2.3%)		9/380 (2.4%)
Cardiac disorders
Myocardial infarcion	35/387 (9%)		23/380 (6.1%)
Angina pectoris	16/387 (4.1%)		22/380 (5.8%)
Coronary artery stenosis	14/387 (3.6%)		17/380 (4.5%)
Bradycardia	11/387 (2.8%)		8/380 (2.1%)
Cardiac failure	8/387 (2.1%)		8/380 (2.1%)
Ventricular tachycardia	8/387 (2.1%)		8/380 (2.1%)
Ventricular extrasystoles	7/387 (1.8%)		6/380 (1.6%)
Atrial fibrillation	5/387 (1.3%)		10/380 (2.6%)
Gastrointestinal disorders
Constipation	59/387 (15.2%)		55/380 (14.5%)
Diarrhoea	26/387 (6.7%)		23/380 (6.1%)
Vomiting	21/387 (5.4%)		27/380 (7.1%)
Nausea	21/387 (5.4%)		26/380 (6.8%)
Abdominal discomfort	9/387 (2.3%)		9/380 (2.4%)
Abdominal pain upper	10/387 (2.6%)		3/380 (0.8%)
Dental Caries	3/387 (0.8%)		8/380 (2.1%)
General disorders
Pyrexia	56/387 (14.5%)		51/380 (13.4%)
Non-cardiac chest pain	8/387 (2.1%)		1/380 (0.3%)
Oedema peripheral	8/387 (2.1%)		12/380 (3.2%)
Puncture site pain	6/387 (1.6%)		7/380 (1.8%)
Hepatobiliary disorders
Hepatic function abnormal	10/387 (2.6%)		9/380 (2.4%)
Infections and infestations
Nasopharyngitis	55/387 (14.2%)		59/380 (15.5%)
Urinary tract infection	10/387 (2.6%)		5/380 (1.3%)
Pneumonia	8/387 (2.1%)		3/380 (0.8%)
Injury, poisoning and procedural complications
In-stent coronary artery restenosis	13/387 (3.4%)		12/380 (3.2%)
Contusion	10/387 (2.6%)		8/380 (2.1%)
Procedural pain	7/387 (1.8%)		1/380 (0.3%)
Coronary artery restenosis	6/387 (1.6%)		9/380 (2.4%)
Metabolism and nutrition disorders
Hyperuricaemia	12/387 (3.1%)		6/380 (1.6%)
Diabetes mellitus	10/387 (2.6%)		5/380 (1.3%)
Musculoskeletal and connective tissue disorders
Back pain	44/387 (11.4%)		46/380 (12.1%)
Pain in extremity	15/387 (3.9%)		10/380 (2.6%)
Myalgia	11/387 (2.8%)		6/380 (1.6%)
Arthralgia	10/387 (2.6%)		11/380 (2.9%)
Musculoskeletal pain	10/387 (2.6%)		10/380 (2.6%)
Nervous system disorders
Headache	33/387 (8.5%)		57/380 (15%)
Dizziness	22/387 (5.7%)		18/380 (4.7%)
Hypoaesthesia	7/387 (1.8%)		12/380 (3.2%)
Psychiatric disorders
Insomnia	58/387 (15%)		49/380 (12.9%)
Restlessness	14/387 (3.6%)		3/380 (0.8%)
Respiratory, thoracic and mediastinal disorders
Cough	23/387 (5.9%)		22/380 (5.8%)
Dyspnoea	22/387 (5.7%)		9/380 (2.4%)
Upper respiratory tract inflammation	8/387 (2.1%)		4/380 (1.1%)
Sleep apnoea syndrome	4/387 (1%)		8/380 (2.1%)
Skin and subcutaneous tissue disorders
Eczema	16/387 (4.1%)		9/380 (2.4%)
Rash	13/387 (3.4%)		20/380 (5.3%)
Blister	8/387 (2.1%)		8/380 (2.1%)
Dermatitis contact	7/387 (1.8%)		5/380 (1.3%)
Erythema	6/387 (1.6%)		8/380 (2.1%)
Pruritus	7/387 (1.8%)		11/380 (2.9%)
Vascular disorders
Hypertension	23/387 (5.9%)		27/380 (7.1%)
Hypotension	9/387 (2.3%)		6/380 (1.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.