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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
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)
Hide 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
Arm/Group Title Rivaroxaban 2.5 mg Twice Daily (BID) Acetylsalicylic Acid 100 mg Once Daily (OD) Total
Hide 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
Hide 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
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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Show Statistical Analysis 1 Hide 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]
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)
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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.
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):
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