Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-8395 | Other Identifier | Product Identification Number | |
| RED-CABG | Other Identifier | Protocol Abbreviation |
Not provided
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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
Not provided
Not provided
Not provided
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The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG surgery.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acadesine | Active Comparator | Acadesine intravenous (IV) infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB) |
|
| Placebo | Placebo Comparator | Normal saline, IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acadesine | Drug | Acadesine 42 mg/kg diluted in normal saline to a total of 500 mL, delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 0.1 mg/kg/min (translating into 1.2 mL/min for a 500 mL solution). In addition, a 5 µg/mL cardioplegia solution of acadesine will be administered, and acadesine will be added to the priming solution (5 µg/mL) in the heart lung machine during CPB. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output. | Up to Post-Operative Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) | Incidence of cardiovascular death, non-fatal stroke, and need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: Cardiovascular death: Death due to cardiovascular causes, Non-fatal Stroke: occurrence of a stroke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output. |
Not provided
Inclusion Criteria:
A high risk participant undergoing non emergency CABG surgery requiring CPB and cardioplegia.
Age: >=50 years
At least one of the following risk factors:
Significant coronary artery stenosis
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25218533 | Derived | Weisel RD, Nussmeier N, Newman MF, Pearl RG, Wechsler AS, Ambrosio G, Pitt B, Clare RM, Pieper KS, Mongero L, Reece TL, Yau TM, Fremes S, Menasche P, Lira A, Harrington RA, Ferguson TB; RED-CABG Executive and Steering Committees. Predictors of contemporary coronary artery bypass grafting outcomes. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2720-6.e1-2. doi: 10.1016/j.jtcvs.2014.08.018. Epub 2014 Aug 14. | |
| 22782417 |
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Acadesine | Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB) |
| FG001 | Placebo (Normal Saline) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Normal Saline | Drug | Normal saline, 500 mL delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 1.2 mL/min for a 500 mL solution. In addition, standard cardioplegia solution with added normal saline will be administered, and placebo (normal saline) will also be added to the heart lung machine priming solution. |
|
| Up to Post-Operative Day 28 |
| Derived |
| Newman MF, Ferguson TB, White JA, Ambrosio G, Koglin J, Nussmeier NA, Pearl RG, Pitt B, Wechsler AS, Weisel RD, Reece TL, Lira A, Harrington RA; RED-CABG Steering Committee and Investigators. Effect of adenosine-regulating agent acadesine on morbidity and mortality associated with coronary artery bypass grafting: the RED-CABG randomized controlled trial. JAMA. 2012 Jul 11;308(2):157-64. doi: 10.1001/jama.2012.7633. |
Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acadesine | Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB) |
| BG001 | Placebo (Normal Saline) | Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output. | The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite. | Posted | Number | Percentage of Participants | Up to Post-Operative Day 28 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) | Incidence of cardiovascular death, non-fatal stroke, and need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: Cardiovascular death: Death due to cardiovascular causes, Non-fatal Stroke: occurrence of a stroke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output. | The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite. | Posted | Number | Percentage of Participants | Up to Post-Operative Day 28 |
|
Up to Post-Operative Day 28
The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acadesine | Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB) | 327 | 1,442 | 1,154 | 1,442 | ||
| EG001 | Placebo (Normal Saline) | Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB | 329 | 1,457 | 1,189 | 1,457 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Heparin-Induced Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial Rupture | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac Tamponade | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac Valve Disease | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiopulmonary Failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Electromechanical Dissociation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nodal Rhythm | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Right Ventricular Failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sick Sinus Syndrome | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Supraventricular Extrasystoles | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ventricle Rupture | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ventricular Arrhythmia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Inappropriate Antidiuretic Hormone Secretion | Endocrine disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diabetic Retinopathy | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal Adhesions | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrointestional Necrosis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ileus Paralytic | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Mallory-Weiss Syndrome | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Malaena | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oesophageal Spasm | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oesophageal Varices Haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Catheter Site Haemorrhage | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Device Occlusion | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Organ Failure | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sudden Cardiac Death | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hydrocholecystis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anaphylactoid Reaction | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bacterial Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cellulitus | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cholecystitis Infective | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Clostridial Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Drug Related Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Escherichia Bacteraemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Haematoma Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Incision Site Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Mediastinal Abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Mediastinitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pyelonepritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pyothorax | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Staphylococcal Mediastinitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Wound Infection Pseudomonas | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Wound Infection Staphylococcal | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Collapse of Lung | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Drug Toxicity | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Graft Haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Incision Site Haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Operative Haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Postoperative Renal Failure | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Postoperative Respiratory Distress | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Postoperative Thoracic Procedure Complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Postpericardiotomy Syndrome | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Renal Injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Shunt Thrombosis | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Traumatic Lung Injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Vascular Graft Occlusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Vascular Graft Complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Vasoplegia Syndrome | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Weaning Failure | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Wound Complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac Output Decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Electrocardiogram Change | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Pulse Absent | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Metabolic Disorder | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fracture Delayed Union | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Anoxic Encephalopathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cerebrovascular Incident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Depressed Level of Consciousness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoxic Encephalopathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Metabolic Encephalopathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Presynope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Affective Disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hallucination, Visual | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Transient Psychosis | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute Prerenal Failure | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal Tubular Necrosis | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute Repiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural Fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary Haematoma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory Alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Tracheal Stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diabetic Ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Linear IGA Disease | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Subcutaneous Emphysema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Aortic Bypass | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Incisional Drainage | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Mechanical Ventilation | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Thoracic Cavity Drainage | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Air Embolism | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Aortic Rupture | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arterial Thrombosis Limb | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arteriovenous Fistula | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Exsanguination | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemodynamic Instability | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Jugular Vein Thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Labile Blood Pressure | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lymphatic Fistula | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Peripheral Embolism | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Peripheral Vascular Disorder | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Shock Haemorrhagic | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thrombophlebitis Superficial | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Venous Thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| White Clot Syndrome | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Generalized Oedema | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
The investigator agrees not to publish or publicly present any interim results
of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media that report any study results).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D018487 | Ventricular Dysfunction, Left |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D018754 | Ventricular Dysfunction |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C011651 | acadesine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Non-Fatal Stroke |
|
| Need for Mechanical Support for SLVD |
|
|
|