Testing Platelet Reactivity In Patients Undergoing Electi... | NCT00910299

ID	Type	Description	Link
H7T-MC-TACW	Other Identifier	Eli Lilly and Company

Name	Class
Daiichi Sankyo Co., Ltd.	INDUSTRY

Label	Type	Description	Intervention Names
Prasugrel	Experimental		Drug: Prasugrel
Clopidogrel	Active Comparator		Drug: Clopidogrel

Name	Type	Description	Arm Group Labels	Other Names
Prasugrel	Drug	One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.	Prasugrel

Measure	Description	Time Frame
Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)	The endpoint in this measure is a combination of cardiovascular death or MI.	Baseline through 6 months

Measure	Description	Time Frame
Number of Participants With Stent Thrombosis (ST)	Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Clearwater	Florida	33756

PubMed Identifier	Type	Citation	Retractions
22520250	Derived	Trenk D, Stone GW, Gawaz M, Kastrati A, Angiolillo DJ, Muller U, Richardt G, Jakubowski JA, Neumann FJ. A randomized trial of prasugrel versus clopidogrel in patients with high platelet reactivity on clopidogrel after elective percutaneous coronary intervention with implantation of drug-eluting stents: results of the TRIGGER-PCI (Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel) study. J Am Coll Cardiol. 2012 Jun 12;59(24):2159-64. doi: 10.1016/j.jacc.2012.02.026. Epub 2012 Apr 18.

ID	Title	Description
FG000	Prasugrel	One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
FG001	Clopidogrel	75 mg oral daily maintenance dose up to 6 months.

ID	Title	Description
BG000	Prasugrel	One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
BG001	Clopidogrel	75 mg oral daily maintenance dose up to 6 months.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000212 BG001211 BG002423

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0006 events6 affected210 at risk EG0012 events2 affected210 at risk
Angina unstable	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Arrhythmia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Bradycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Cardiac failure	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0012 events2 affected210 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Pericardial effusion	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Deafness	Ear and labyrinth disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Gastritis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected210 at risk
Melaena	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected210 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Catheter site haemorrhage	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0015 events5 affected210 at risk
Arthritis infective	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Bronchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events1 affected210 at risk
Diverticulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Erysipelas	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Sepsis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Viral infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events2 affected210 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected210 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Blood creatinine increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Troponin increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected210 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Burkitt's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Oropharyngeal cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Neuralgia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Syncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Depression	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events1 affected210 at risk
Panic attack	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Renal impairment	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected210 at risk EG0010 events0 affected210 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Aortic aneurysm	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events2 affected210 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Hypertensive crisis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected210 at risk EG0012 events2 affected210 at risk
Intermittent claudication	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected210 at risk EG0010 events0 affected210 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0006 events6 affected210 at risk EG0012 events2 affected210 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0011 events1 affected210 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0013 events3 affected210 at risk
Bradycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Bundle branch block left	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Coronary artery disease	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events2 affected210 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0010 events0 affected210 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0012 events2 affected210 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Conjunctivitis	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Glaucoma	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events1 affected210 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected210 at risk EG0016 events6 affected210 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Gastritis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0012 events1 affected210 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Gingivitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected210 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0013 events3 affected210 at risk
Periodontitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0011 events1 affected210 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events2 affected210 at risk
Oedema due to cardiac disease	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Oedema peripheral	General disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected210 at risk EG0012 events2 affected210 at risk
Vessel puncture site haematoma	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Seasonal allergy	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Acute tonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Bronchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0004 events3 affected210 at risk EG0012 events2 affected210 at risk
Cystitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0011 events1 affected210 at risk
Diverticulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Erysipelas	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0010 events0 affected210 at risk
Furuncle	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected210 at risk EG0010 events0 affected210 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0013 events3 affected210 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00018 events15 affected210 at risk EG0018 events8 affected210 at risk
Onychomycosis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Oral herpes	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Otitis externa	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected210 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0007 events7 affected210 at risk EG0012 events2 affected210 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Joint capsule rupture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected210 at risk EG0010 events0 affected210 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected210 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected210 at risk EG0014 events4 affected210 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0010 events0 affected210 at risk
Arteriogram coronary	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Blood creatine increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events2 affected210 at risk
Blood creatine phosphokinase mb increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
White blood cell count increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0013 events3 affected210 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0010 events0 affected210 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected210 at risk
Hypokalaemic syndrome	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected210 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events2 affected210 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0011 events1 affected210 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Jaw cyst	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0010 events0 affected210 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Rheumatic fever	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Dizziness	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected210 at risk
Dizziness postural	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Dysgeusia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Sciatica	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Syncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Insomnia	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Nightmare	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Panic attack	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Sleep disorder	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected210 at risk EG0010 events0 affected210 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00021 events20 affected210 at risk EG00110 events8 affected210 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected210 at risk EG0013 events3 affected210 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0006 events6 affected210 at risk EG0011 events1 affected210 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events2 affected210 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected210 at risk EG0011 events1 affected210 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0013 events3 affected210 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Limb operation	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Nasal septal operation	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected210 at risk EG0010 events0 affected210 at risk
Renal revascularisation surgery	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Smoking cessation therapy	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected210 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Haematoma	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Hot flush	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected210 at risk EG0012 events2 affected210 at risk
Hypotension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Thrombophlebitis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk
Varicose vein	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected210 at risk

ID	Term
D003324	Coronary Artery Disease
D006331	Heart Diseases

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013988	Ticlopidine
D058924	Thienopyridines
D011725	Pyridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Prasugrel	One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months			40	210	110	210
EG001	Clopidogrel	75 mg oral daily maintenance dose up to 6 months.			38	210	72	210