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The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cangrelor | Experimental | Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. Following the discontinuation of the cangrelor infusion, 600mg of clopidogrel was administered. |
|
| clopidogrel | Active Comparator | Clopidogrel 300 mg or 600 mg administered pre or post PCI. Selection of dose and timing of dose were per investigator discretion. During the PCI a placebo infusion was given to maintain the blinding of the trial. In addition, placebo capsules were administered at the end of the infusion mimic the 600mg post infusion dose provided in the cangrelor arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cangrelor P2Y12 (platelet) inhibitor | Drug |
| ||
| Clopidogrel - 300 or 600 mg (study arm) |
| Measure | Description | Time Frame |
|---|---|---|
| The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) | Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population) | 48 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) | CEC-adjudicated results (mITT population) | 48 hours after randomization |
| Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild |
Not provided
Inclusion Criteria:
Patients may be included in the study if they meet all of the following criteria:
Male or non-pregnant female at least 18 years of age
Patients undergoing percutaneous coronary intervention (PCI):
Provide written informed consent
Exclusion Criteria:
Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anderson Area Medical Center | Anderson | South Carolina | 29621 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38551015 | Derived | Gutierrez JA, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL; CHAMPION Investigators. Efficacy and safety of cangrelor in patients with peripheral artery disease undergoing percutaneous coronary intervention - Insights from the CHAMPION program. Am Heart J Plus. 2021 Aug 25;9:100043. doi: 10.1016/j.ahjo.2021.100043. eCollection 2021 Sep. | |
| 35196863 |
Not provided
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Due to the nature of the disease, STEMI patients were permitted to be randomized upon ECG confirmation and prior to confirmation of need for PCI (prior to diagnostic angiography). Therefore in some cases, STEMI patients did not require PCI and therefore did not receive all study drug.
Date first patient enrolled: 30 Sep 2010 Date last patient completed: 14 Nov 2012
This trial enrolled the full spectrum of patients who required PCI (SA, NSTE-ACS, STEMI). Randomization occurred after confirmation of need for PCI (after diagnostic angiogram in all cases, except for STEMI patients). Patients were followed through 30-days.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cangrelor Treatment Arm | Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered. Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| Drug |
Over encapsulated tablets. |
|
| Clopidogrel 600 mg post cangrelor | Drug | over-encapsulated clopidogrel (600 mg) |
|
GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial |
| 48 hours after randomization |
| Derived |
| Peterson BE, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL. Effect of Platelet Inhibition by Cangrelor Among Obese Patients Undergoing Coronary Stenting: Insights From CHAMPION. Circ Cardiovasc Interv. 2022 Mar;15(3):e011069. doi: 10.1161/CIRCINTERVENTIONS.121.011069. Epub 2022 Feb 24. |
| 34915723 | Derived | Cavender MA, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Deliargyris EN, Prats J, Mahaffey KW, White HD, Bhatt DL; CHAMPION PHOENIX Investigators*. Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX. Circ Cardiovasc Interv. 2022 Jan;15(1):e010390. doi: 10.1161/CIRCINTERVENTIONS.120.010390. Epub 2021 Dec 17. |
| 31296081 | Derived | Olivier CB, Bhatt DL, Leonardi S, Stone GW, Gibson CM, Steg PG, Hamm CW, Wilson MD, Mangum S, Price MJ, Prats J, White HD, Lopes RD, Harrington RA, Mahaffey KW; CHAMPION PHOENIX Investigators *. Central Adjudication Identified Additional and Prognostically Important Myocardial Infarctions in Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2019 Jul;12(7):e007342. doi: 10.1161/CIRCINTERVENTIONS.118.007342. Epub 2019 Jul 12. |
| 30871355 | Derived | Abtan J, Ducrocq G, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm CW, Price MJ, Prats J, Deliargyris EN, White HD, Harrington RA, Bhatt DL. Periprocedural Outcomes According to Timing of Clopidogrel Loading Dose in Patients Who Did Not Receive P2Y12 Inhibitor Pretreatment. Circ Cardiovasc Interv. 2019 Mar;12(3):e007445. doi: 10.1161/CIRCINTERVENTIONS.118.007445. |
| 30563770 | Derived | Abtan J, Ducrocq G, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm C, Price MJ, Prats J, Elkin S, Deliargyris EN, White HD, Menozzi A, Harrington RA, Bhatt DL; MPH on Behalf of the CHAMPION PHOENIX Investigators. Characteristics and outcomes of patients requiring bailout use of glycoprotein IIb/IIIa inhibitors for thrombotic complications of percutaneous coronary intervention: An analysis from the CHAMPION PHOENIX trial. Int J Cardiol. 2019 Mar 1;278:217-222. doi: 10.1016/j.ijcard.2018.11.114. Epub 2018 Nov 23. |
| 30203006 | Derived | Stone GW, Genereux P, Harrington RA, White HD, Gibson CM, Steg PG, Hamm CW, Mahaffey KW, Price MJ, Prats J, Deliargyris EN, Bhatt DL. Impact of lesion complexity on peri-procedural adverse events and the benefit of potent intravenous platelet adenosine diphosphate receptor inhibition after percutaneous coronary intervention: core laboratory analysis from 10 854 patients from the CHAMPION PHOENIX trial. Eur Heart J. 2018 Dec 7;39(46):4112-4121. doi: 10.1093/eurheartj/ehy562. |
| 29632238 | Derived | Groves EM, Bhatt DL, Steg PG, Deliargyris EN, Stone GW, Gibson CM, Hamm CW, Mahaffey KW, White HD, Angiolillo DJ, Prats J, Harrington RA, Price MJ. Incidence, Predictors, and Outcomes of Acquired Thrombocytopenia After Percutaneous Coronary Intervention: A Pooled, Patient-Level Analysis of the CHAMPION Trials (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition). Circ Cardiovasc Interv. 2018 Apr;11(4):e005635. doi: 10.1161/CIRCINTERVENTIONS.117.005635. |
| 28988157 | Derived | Vaduganathan M, Harrington RA, Stone GW, Steg G, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Deliargyris EN, Prats J, Mahaffey KW, White HD, Bhatt DL. Short- and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention: insights from four validated bleeding scales in the CHAMPION trials. EuroIntervention. 2018 Feb 2;13(15):e1841-e1849. doi: 10.4244/EIJ-D-17-00723. |
| 28801539 | Derived | Cavender MA, Bhatt DL, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Prats J, Elkin S, Deliargyris EN, Mahaffey KW, White HD, Harrington RA; CHAMPION PHOENIX Investigators*. Cangrelor in Older Patients Undergoing Percutaneous Coronary Intervention: Findings From CHAMPION PHOENIX. Circ Cardiovasc Interv. 2017 Aug;10(8):e005257. doi: 10.1161/CIRCINTERVENTIONS.117.005257. |
| 28382371 | Derived | Parker WA, Bhatt DL, Prats J, Day JRS, Steg PG, Stone GW, Hamm CW, Mahaffey KW, Price MJ, Gibson CM, White HD, Storey RF; CHAMPION PHOENIX Investigators. Characteristics of dyspnoea and associated clinical outcomes in the CHAMPION PHOENIX study. Thromb Haemost. 2017 Jun 2;117(6):1093-1100. doi: 10.1160/TH16-12-0958. Epub 2017 Apr 6. |
| 28081827 | Derived | Vaduganathan M, Harrington RA, Stone GW, Deliargyris EN, Steg PG, Gibson CM, Hamm CW, Price MJ, Menozzi A, Prats J, Elkin S, Mahaffey KW, White HD, Bhatt DL; CHAMPION Investigators. Cangrelor With and Without Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Jan 17;69(2):176-185. doi: 10.1016/j.jacc.2016.10.055. |
| 27902833 | Derived | Vaduganathan M, Harrington RA, Stone GW, Deliargyris EN, Steg PG, Gibson CM, Hamm CW, Price MJ, Menozzi A, Prats J, Elkin S, Mahaffey KW, White HD, Bhatt DL. Evaluation of Ischemic and Bleeding Risks Associated With 2 Parenteral Antiplatelet Strategies Comparing Cangrelor With Glycoprotein IIb/IIIa Inhibitors: An Exploratory Analysis From the CHAMPION Trials. JAMA Cardiol. 2017 Feb 1;2(2):127-135. doi: 10.1001/jamacardio.2016.4556. |
| 27659566 | Derived | Abtan J, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm CW, Price MJ, Abnousi F, Prats J, Deliargyris EN, White HD, Harrington RA, Bhatt DL; CHAMPION PHOENIX Investigators. Efficacy and Safety of Cangrelor in Preventing Periprocedural Complications in Patients With Stable Angina and Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: The CHAMPION PHOENIX Trial. JACC Cardiovasc Interv. 2016 Sep 26;9(18):1905-13. doi: 10.1016/j.jcin.2016.06.046. |
| 27482008 | Derived | Cavender MA, Bhatt DL, Stone GW, White HD, Steg PG, Gibson CM, Hamm CW, Price MJ, Leonardi S, Prats J, Deliargyris EN, Mahaffey KW, Harrington RA; CHAMPION PHOENIX Investigators*. Consistent Reduction in Periprocedural Myocardial Infarction With Cangrelor as Assessed by Multiple Definitions: Findings From CHAMPION PHOENIX (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition). Circulation. 2016 Sep 6;134(10):723-33. doi: 10.1161/CIRCULATIONAHA.115.020829. Epub 2016 Aug 1. |
| 27313282 | Derived | Vaduganathan M, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL. Variation in Patient Profiles and Outcomes in US and Non-US Subgroups of the Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX Trial. Circ Cardiovasc Interv. 2016 Jun;9(6):e003612. doi: 10.1161/CIRCINTERVENTIONS.116.003612. |
| 26762525 | Derived | O'Donoghue ML, Bhatt DL, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Prats J, Liu T, Deliargyris EN, Mahaffey KW, White HD, Harrington RA; CHAMPION PHOENIX Investigators. Efficacy and Safety of Cangrelor in Women Versus Men During Percutaneous Coronary Intervention: Insights From the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) Trial. Circulation. 2016 Jan 19;133(3):248-55. doi: 10.1161/CIRCULATIONAHA.115.017300. |
| 26400827 | Derived | Gutierrez JA, Harrington RA, Blankenship JC, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Genereux P, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL; CHAMPION PHOENIX Investigators. The effect of cangrelor and access site on ischaemic and bleeding events: insights from CHAMPION PHOENIX. Eur Heart J. 2016 Apr 7;37(14):1122-30. doi: 10.1093/eurheartj/ehv498. Epub 2015 Sep 23. |
| 24184169 | Derived | Genereux P, Stone GW, Harrington RA, Gibson CM, Steg PG, Brener SJ, Angiolillo DJ, Price MJ, Prats J, LaSalle L, Liu T, Todd M, Skerjanec S, Hamm CW, Mahaffey KW, White HD, Bhatt DL; CHAMPION PHOENIX Investigators. Impact of intraprocedural stent thrombosis during percutaneous coronary intervention: insights from the CHAMPION PHOENIX Trial (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). J Am Coll Cardiol. 2014 Feb 25;63(7):619-629. doi: 10.1016/j.jacc.2013.10.022. Epub 2013 Oct 30. |
| 23473369 | Derived | Bhatt DL, Stone GW, Mahaffey KW, Gibson CM, Steg PG, Hamm CW, Price MJ, Leonardi S, Gallup D, Bramucci E, Radke PW, Widimsky P, Tousek F, Tauth J, Spriggs D, McLaurin BT, Angiolillo DJ, Genereux P, Liu T, Prats J, Todd M, Skerjanec S, White HD, Harrington RA; CHAMPION PHOENIX Investigators. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med. 2013 Apr 4;368(14):1303-13. doi: 10.1056/NEJMoa1300815. Epub 2013 Mar 10. |
| 22607853 | Derived | Leonardi S, Mahaffey KW, White HD, Gibson CM, Stone GW, Steg GW, Hamm CW, Price MJ, Todd M, Dietrich M, Gallup D, Liu T, Skerjanec S, Harrington RA, Bhatt DL. Rationale and design of the Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON PHOENIX trial. Am Heart J. 2012 May;163(5):768-776.e2. doi: 10.1016/j.ahj.2012.02.018. |
| FG001 | Clopidogrel Treatment Arm | Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator. Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose. |
| COMPLETED |
|
| NOT COMPLETED |
|
ITT population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cangrelor Treatment Arm | Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered. Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose. |
| BG001 | Clopidogrel Treatment Arm | Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator. Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) | Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population) | Posted | Number | participants | 48 hours after randomization |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) | CEC-adjudicated results (mITT population) | Posted | Number | participants | 48 hours after randomization |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild | GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial | Posted | Number | participants | 48 hours after randomization |
|
|
AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Not provided
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 | Cangrelor Treatment Arm | 122 | 5,529 | 0 | 5,529 | |||
| EG001 | Clopidogrel Treatment Arm | 105 | 5,527 | 0 | 5,527 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
| |||
| Hypersplenism | Blood and lymphatic system disorders |
| |||
| Pancytopenia | Blood and lymphatic system disorders |
| |||
| acute coronary syndrome | Cardiac disorders |
| |||
| acute myocardial infarction | Cardiac disorders |
| |||
| angina pectoris | Cardiac disorders |
| |||
| angina unstable | Cardiac disorders |
| |||
| Arteriospasm coronary | Cardiac disorders |
| |||
| atrial fibrillation | Cardiac disorders |
| |||
| atrioventricular block complete | Cardiac disorders |
| |||
| bradycardia | Cardiac disorders |
| |||
| cardiac arrest | Cardiac disorders |
| |||
| cardiac failure | Cardiac disorders |
| |||
| cardiac failure acute | Cardiac disorders |
| |||
| cardiac failure congestive | Cardiac disorders |
| |||
| cardiac tamponade | Cardiac disorders |
| |||
| cardio-respiratory arrest | Cardiac disorders |
| |||
| cardiogenic shock | Cardiac disorders |
| |||
| coronary artery disease | Cardiac disorders |
| |||
| coronary artery dissection | Cardiac disorders |
| |||
| coronary artery occlusion | Cardiac disorders |
| |||
| coronary artery performation | Cardiac disorders |
| |||
| Interventricluar septum rupture | Cardiac disorders |
| |||
| myocardial infarction | Cardiac disorders |
| |||
| mycardial rupture | Cardiac disorders |
| |||
| nodal arrhythmia | Cardiac disorders |
| |||
| percarditis | Cardiac disorders |
| |||
| sick sinus syndrome | Cardiac disorders |
| |||
| sinus arrest | Cardiac disorders |
| |||
| ventricular rupture | Cardiac disorders |
| |||
| ventricular asystole | Cardiac disorders |
| |||
| ventricular fibrillation | Cardiac disorders |
| |||
| ventricluar tachycardia | Cardiac disorders |
| |||
| gastroesophageal reflux disease | Gastrointestinal disorders |
| |||
| chest discomfort | General disorders |
| |||
| chest pain | General disorders |
| |||
| non-cardiac chest pain | General disorders |
| |||
| pyrexia | General disorders |
| |||
| thrombosis in device | General disorders |
| |||
| hepatic cirrhosis | Hepatobiliary disorders |
| |||
| anaphylactic reaction | Immune system disorders |
| |||
| anaphylactic shock | Immune system disorders |
| |||
| hypersensitivity | Immune system disorders |
| |||
| bronchitis | Infections and infestations |
| |||
| pneumonia | Infections and infestations |
| |||
| septic shock | Infections and infestations |
| |||
| small intestine gangrene | Infections and infestations |
| |||
| urinary tract infection | Infections and infestations |
| |||
| cardiac procedure complication | Injury, poisoning and procedural complications |
| |||
| fall | Injury, poisoning and procedural complications |
| |||
| head injury | Injury, poisoning and procedural complications |
| |||
| medication error | Injury, poisoning and procedural complications |
| |||
| postoperative ileus | Injury, poisoning and procedural complications |
| |||
| subdural haematoma | Injury, poisoning and procedural complications |
| |||
| vascular pseudoaneurysm | Injury, poisoning and procedural complications |
| |||
| blood creatinine increased | Investigations |
| |||
| electrocardiogram ST segment elevation | Investigations |
| |||
| troponin increased | Investigations |
| |||
| diabetes mellitus | Metabolism and nutrition disorders |
| |||
| fluid overload | Metabolism and nutrition disorders |
| |||
| compartment syndrome | Musculoskeletal and connective tissue disorders |
| |||
| neck pain | Musculoskeletal and connective tissue disorders |
| |||
| cerebrovascular accident | Nervous system disorders |
| |||
| embolic cerebral infarction | Nervous system disorders |
| |||
| ischaemic stroke | Nervous system disorders |
| |||
| lethargy | Nervous system disorders |
| |||
| migraine | Nervous system disorders |
| |||
| presyncope | Nervous system disorders |
| |||
| transient ischaemic attack | Nervous system disorders |
| |||
| delirium | Psychiatric disorders |
| |||
| mental status changes | Psychiatric disorders |
| |||
| nephrolithiasis | Renal and urinary disorders |
| |||
| nephropathy toxic | Renal and urinary disorders |
| |||
| renal failure | Renal and urinary disorders |
| |||
| renal failure acute | Renal and urinary disorders |
| |||
| renal impairment | Renal and urinary disorders |
| |||
| aspiration | Respiratory, thoracic and mediastinal disorders |
| |||
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
| |||
| dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| dyspnoea exertional | Respiratory, thoracic and mediastinal disorders |
| |||
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
| |||
| pulmonary oedema | Respiratory, thoracic and mediastinal disorders |
| |||
| respiratory failure | Respiratory, thoracic and mediastinal disorders |
| |||
| aortic dissection | Vascular disorders |
| |||
| arterial rupture | Vascular disorders |
| |||
| circulatory collapse | Vascular disorders |
| |||
| deep vein thrombosis | Vascular disorders |
| |||
| hypertension | Vascular disorders |
| |||
| hypotension | Vascular disorders |
|
Not provided
In general, PI communications regarding trial results are prohibited until after the communication and publication of the multi-center results by Sponsor, but no more than 12 months after conclusion of the trial at all sites.
PI must submit results communications to sponsor for review at least 45 days prior to submission for publication and Sponsor may embargo such communications for a period that is less than or equal to 135 days solely to seek appropriate patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith Todd - Sr. Director Program Management | The Medicines Company | +1.973.290.6088 | meredith.todd@themedco.com |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010976 | Platelet Count |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D010979 | Platelet Function Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Austria |
|
| Brazil |
|
| Bulgaria |
|
| Czech Republic |
|
| Georgia |
|
| Germany |
|
| Italy |
|
| New Zealand |
|
| Poland |
|
| Russian Federation |
|
| Thailand |
|
|
|