A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome (GEMINI ACS 1)

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ClinicalTrials.gov Identifier: NCT02293395

Recruitment Status : Completed

First Posted : November 18, 2014

Results First Posted : November 13, 2017

Last Update Posted : December 26, 2017

Sponsor:

Collaborators:

Bayer

Duke Clinical Research Institute

Harvard Medical School

Information provided by (Responsible Party):

Janssen Research & Development, LLC

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Acute Coronary Syndrome
Interventions	Drug: Acetylsalicylic acid Drug: Rivaroxaban Drug: Clopidogrel Drug: Ticagrelor
Enrollment	3037

Participant Flow

Recruitment Details
Pre-assignment Details	A total of 3,145 participants were screened for eligibility, of these 108 participants were screening failures and the remaining 3,037 participants were randomized.


Arm/Group Title	Rivaroxaban 2.5 mg Twice Daily (BID)	Acetylsalicylic Acid 100 mg Once Daily (OD)
Arm/Group Description	Participants received oral dose of ...	Participants received oral dose of ...
Arm/Group Description	Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
Period Title: Overall Study
Started	1519	1518
Treated	1510	1506
Completed	1510	1511
Not Completed	9	7
Reason Not Completed
Lost to Follow-up	1	0
Withdrawal by Subject	8	7

Baseline Characteristics

Arm/Group Title		Rivaroxaban 2.5 mg Twice Daily (BID)	Acetylsalicylic Acid 100 mg Once Daily (OD)	Total
Arm/Group Description		Participants received oral dose of ...	Participants received oral dose of ...	Total of all reporting groups
Arm/Group Description		Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Total of all reporting groups
Overall Number of Baseline Participants		1519	1518	3037
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	1519 participants	1518 participants	3037 participants
		62.7 (9.14)	62.9 (8.82)	62.8 (8.98)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1519 participants	1518 participants	3037 participants
	Female	385 25.3%	377 24.8%	762 25.1%
	Male	1134 74.7%	1141 75.2%	2275 74.9%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1519 participants	1518 participants	3037 participants
	White	1417 93.3%	1407 92.7%	2824 93.0%
	Black	24 1.6%	16 1.1%	40 1.3%
	Asian	54 3.6%	63 4.2%	117 3.9%
	Others	24 1.6%	32 2.1%	56 1.8%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	1519 participants	1518 participants	3037 participants
ARGENTINA		66	65	131
AUSTRALIA		18	17	35
BELGIUM		49	40	89
BRAZIL		77	85	162
BULGARIA		83	78	161
CANADA		37	47	84
CZECH REPUBLIC		34	37	71
DENMARK		1	2	3
FRANCE		28	29	57
HUNGARY		101	100	201
ITALY		75	59	134
JAPAN		26	33	59
NETHERLANDS		69	65	134
POLAND		158	175	333
RUSSIA		237	244	481
SPAIN		62	60	122
SWEDEN		42	37	79
TURKEY		102	98	200
UKRAINE		137	129	266
UNITED STATES		93	88	181
Korea, Republic Of		24	30	54

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events
Description	Non CABG-related TIMI clinically significant bleeding events are sum o...
Description	Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of >=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - <5 g/dl (or drop in hematocrit of 9 - <15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.
Time Frame	From start of study treatment until follow-up (up to 390 days)

Outcome Measure Data

Analysis Population Description

Population analyzed included all randomized participants who had received at least one dose of study agent and had events that occurred between randomization and the last dose of the study agent plus 2 days or untreated participants who had events that occurred between randomization to 2 days thereafter.


Arm/Group Title	Rivaroxaban 2.5 mg Twice Daily (BID)	Acetylsalicylic Acid 100 mg Once Daily (OD)
Arm/Group Description:	Participants received oral dose of ...	Participants received oral dose of ...
Arm/Group Description:	Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
Overall Number of Participants Analyzed	1519	1518
Measure Type: Number Unit of Measure: participants
	80	74

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rivaroxaban 2.5 mg Twice Daily (BID), Acetylsalicylic Acid 100 mg Once Daily (OD)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.584
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95% 0.8 to 1.5
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Up to 390 days
Adverse Event Reporting Description	Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.

Arm/Group Title	Rivaroxaban 2.5 mg Twice Daily (BID)	Acetylsalicylic Acid 100 mg Once Daily (OD)
Arm/Group Description	Participants received oral dose of ...	Participants received oral dose of ...
Arm/Group Description	Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
All-Cause Mortality
	Rivaroxaban 2.5 mg Twice Daily (BID)	Acetylsalicylic Acid 100 mg Once Daily (OD)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Rivaroxaban 2.5 mg Twice Daily (BID)	Acetylsalicylic Acid 100 mg Once Daily (OD)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	125/1510 (8.28%)	138/1506 (9.16%)
Blood and lymphatic system disorders
Anaemia ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Cardiac disorders
Acute Left Ventricular Failure ^* 1	3/1510 (0.20%)	0/1506 (0.00%)
Acute Myocardial Infarction ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Angina Pectoris ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Angina Unstable ^* 1	5/1510 (0.33%)	5/1506 (0.33%)
Aortic Valve Stenosis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Atrial Fibrillation ^* 1	3/1510 (0.20%)	7/1506 (0.46%)
Atrial Flutter ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Atrioventricular Block Second Degree ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Bradycardia ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Cardiac Failure ^* 1	9/1510 (0.60%)	7/1506 (0.46%)
Cardiac Failure Acute ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Cardiac Failure Chronic ^* 1	3/1510 (0.20%)	0/1506 (0.00%)
Cardiac Failure Congestive ^* 1	2/1510 (0.13%)	1/1506 (0.07%)
Cardiac Ventricular Thrombosis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Cardiovascular Insufficiency ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Coronary Artery Disease ^* 1	2/1510 (0.13%)	0/1506 (0.00%)
Coronary Artery Stenosis ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Intracardiac Thrombus ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Mitral Valve Incompetence ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Myocardial Fibrosis ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Myocardial Ischaemia ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Myocardial Rupture ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Pericarditis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Pleuropericarditis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Postinfarction Angina ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Sinus Arrest ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Ventricular Extrasystoles ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Ear and labyrinth disorders
Vertigo ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Vertigo Positional ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Eye disorders
Cataract ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Gastrointestinal disorders
Abdominal Pain ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Chronic Gastritis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Colitis Ulcerative ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Diverticulum Intestinal ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Erosive Oesophagitis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Gastritis ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Gastroduodenitis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Intestinal Obstruction ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Pancreatic Necrosis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Pancreatitis Acute ^* 1	1/1510 (0.07%)	2/1506 (0.13%)
Pancreatitis Chronic ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
General disorders
Chest Pain ^* 1	2/1510 (0.13%)	2/1506 (0.13%)
Death ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Implant Site Ulcer ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Multiple Organ Dysfunction Syndrome ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Non-Cardiac Chest Pain ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Stent-Graft Endoleak ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Vascular Stent Restenosis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Vascular Stent Stenosis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Hepatobiliary disorders
Cholangitis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Cholecystitis ^* 1	2/1510 (0.13%)	1/1506 (0.07%)
Cholecystitis Acute ^* 1	3/1510 (0.20%)	5/1506 (0.33%)
Cholelithiasis ^* 1	3/1510 (0.20%)	1/1506 (0.07%)
Drug-Induced Liver Injury ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Infections and infestations
Appendicitis ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Bronchitis ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Diverticulitis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Gangrene ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Gastrointestinal Infection ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
H1n1 Influenza ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Herpes Zoster ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Infectious Pleural Effusion ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Infective Exacerbation of Chronic Obstructive Airways Disease ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Influenza ^* 1	2/1510 (0.13%)	0/1506 (0.00%)
Orchitis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Periodontitis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Pneumonia ^* 1	7/1510 (0.46%)	5/1506 (0.33%)
Postoperative Wound Infection ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Pyelonephritis Chronic ^* 1	2/1510 (0.13%)	1/1506 (0.07%)
Respiratory Tract Infection ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Spinal Cord Infection ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Urinary Tract Infection ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Injury, poisoning and procedural complications
Alcohol Poisoning ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Concussion ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Coronary Artery Restenosis ^* 1	1/1510 (0.07%)	3/1506 (0.20%)
Hand Fracture ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Heat Illness ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Hip Fracture ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Humerus Fracture ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Joint Dislocation ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Laceration ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Ligament Sprain ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Lower Limb Fracture ^* 1	1/1510 (0.07%)	2/1506 (0.13%)
Lumbar Vertebral Fracture ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Radius Fracture ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Spinal Fracture ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Ulna Fracture ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Vascular Access Site Pain ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Vascular Graft Occlusion ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Vascular Pseudoaneurysm ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Investigations
Cardiac Stress Test Abnormal ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Haemoglobin Decreased ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Hepatic Enzyme Increased ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Liver Function Test Increased ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Mediastinoscopy ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Weight Decreased ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Metabolism and nutrition disorders
Diabetes Mellitus ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Hyperglycaemia ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Hypoglycaemia ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Musculoskeletal and connective tissue disorders
Costochondritis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Intervertebral Disc Disorder ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Intervertebral Disc Protrusion ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Ligamentitis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Musculoskeletal Discomfort ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Osteoarthritis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Rapidly Progressive Osteoarthritis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Rhabdomyolysis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Rheumatoid Arthritis ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Tenosynovitis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Cervix Carcinoma Recurrent ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Colon Cancer Recurrent ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Gastric Cancer ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Gastrointestinal Carcinoma ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Hepatocellular Carcinoma ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Laryngeal Cancer ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Lung Neoplasm Malignant ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Pancreatic Carcinoma ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Prostate Cancer ^* 1	2/1510 (0.13%)	1/1506 (0.07%)
Rectal Adenocarcinoma ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Renal Neoplasm ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Salivary Gland Cancer Recurrent ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Squamous Cell Carcinoma ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Uterine Cancer ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Uterine Leiomyoma ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Vascular Neoplasm ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Nervous system disorders
Carotid Artery Stenosis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Facial Paralysis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Intracranial Aneurysm ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Presyncope ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Seizure ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Syncope ^* 1	2/1510 (0.13%)	3/1506 (0.20%)
Vertebral Artery Stenosis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Psychiatric disorders
Alcohol Withdrawal Syndrome ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Depression ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Panic Attack ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Renal and urinary disorders
Acute Kidney Injury ^* 1	1/1510 (0.07%)	2/1506 (0.13%)
Nephrolithiasis ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Nephropathy Toxic ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Renal Artery Stenosis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Renal Colic ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Ureterolithiasis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Urinary Retention ^* 1	2/1510 (0.13%)	0/1506 (0.00%)
Urinary Tract Obstruction ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema ^* 1	0/1510 (0.00%)	2/1506 (0.13%)
Acute Respiratory Failure ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Asthma ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Chronic Obstructive Pulmonary Disease ^* 1	1/1510 (0.07%)	3/1506 (0.20%)
Cough ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Dyspnoea ^* 1	4/1510 (0.26%)	4/1506 (0.27%)
Pleurisy ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Pulmonary Embolism ^* 1	0/1510 (0.00%)	4/1506 (0.27%)
Pulmonary Mass ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Pulmonary Oedema ^* 1	3/1510 (0.20%)	3/1506 (0.20%)
Respiratory Failure ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Surgical and medical procedures
Inguinal Hernia Repair ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Lung Neoplasm Surgery ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Lymphadenectomy ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Vascular disorders
Aortic Aneurysm ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Arteriosclerosis ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Brachiocephalic Arteriosclerosis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Hypertension ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Hypertensive Crisis ^* 1	5/1510 (0.33%)	2/1506 (0.13%)
Hypotension ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Peripheral Arterial Occlusive Disease ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Peripheral Artery Aneurysm ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Peripheral Artery Occlusion ^* 1	0/1510 (0.00%)	1/1506 (0.07%)
Peripheral Artery Stenosis ^* 1	1/1510 (0.07%)	1/1506 (0.07%)
Subclavian Artery Stenosis ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
Vascular Occlusion ^* 1	1/1510 (0.07%)	0/1506 (0.00%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA Version 19.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Rivaroxaban 2.5 mg Twice Daily (BID)	Acetylsalicylic Acid 100 mg Once Daily (OD)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	81/1510 (5.36%)	84/1506 (5.58%)
General disorders
Chest Pain ^* 1	11/1510 (0.73%)	19/1506 (1.26%)
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	16/1510 (1.06%)	14/1506 (0.93%)
Dyspnoea ^* 1	33/1510 (2.19%)	39/1506 (2.59%)
Vascular disorders
Hypertension ^* 1	23/1510 (1.52%)	22/1506 (1.46%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA Version 19.0

Limitations and Caveats

Study population was homogenous with limited participation of non-Caucasian participants. Randomization was not performed for use of P2Y12 inhibitor; strata comparisons between bleeding and efficacy endpoints are confounded and were not planned.

More Information

Certain Agreements

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

There IS 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.

A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Associate Director
Organization:	Janssen Research & Development, LLC
EMail:	ClinicalTrialDisclosure@its.jnj.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2019 Sep 18. doi: 10.1007/s11239-019-01940-8. [Epub ahead of print]

Povsic TJ, Ohman EM, Roe MT, White J, Rockhold FW, Montalescot G, Cornel JH, Nicolau JC, Steg PG, James S, Bode C, Welsh RC, Plotnikov AN, Mundl H, Gibson CM. P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes. JAMA Cardiol. 2019 Jul 1;4(7):680-684. doi: 10.1001/jamacardio.2019.1510.

Ohman EM, Roe MT, Steg PG, James SK, Povsic TJ, White J, Rockhold F, Plotnikov A, Mundl H, Strony J, Sun X, Husted S, Tendera M, Montalescot G, Bahit MC, Ardissino D, Bueno H, Claeys MJ, Nicolau JC, Cornel JH, Goto S, Kiss RG, Güray Ü, Park DW, Bode C, Welsh RC, Gibson CM. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017 May 6;389(10081):1799-1808. doi: 10.1016/S0140-6736(17)30751-1. Epub 2017 Mar 18.

Povsic TJ, Roe MT, Ohman EM, Steg PG, James S, Plotnikov A, Mundl H, Welsh R, Bode C, Gibson CM. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study. Am Heart J. 2016 Apr;174:120-8. doi: 10.1016/j.ahj.2016.01.004. Epub 2016 Jan 18.

Layout table for additonal information

Responsible Party:	Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT02293395 History of Changes
Other Study ID Numbers:	CR106261 RIVAROXACS2002 ( Other Identifier: Janssen Research & Development, LLC ) 2014-004266-26 ( EudraCT Number )
First Submitted:	November 13, 2014
First Posted:	November 18, 2014
Results First Submitted:	October 11, 2017
Results First Posted:	November 13, 2017
Last Update Posted:	December 26, 2017

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