Not provided
Not provided
Not provided
Not provided
Insufficient evidence of the clinical effectiveness of cangrelor
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.
Not provided
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cangrelor | Experimental | placebo capsules (to match) + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion |
|
| Clopidogrel | Active Comparator | clopidogrel capsules (600 mg) + placebo bolus & infusion (to match) + placebo capsules (to match) post infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cangrelor (P2Y12 inhibitor) | Drug | IV bolus (30 mcg/kg) & infusion (4 mcg/kg/min) initiated prior to PCI, as soon as possible following randomization (after need for PCI is confirmed) but not more than 30 minutes prior to placement of arterial access. Infusion is to continue for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) | (composite incidence) | randomization through 48 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All-cause Mortality and MI | (composite incidence) | randomization through 48 hours after randomization |
| Individual Incidence of All-cause Mortality | randomization through 48 hours after randomization |
Not provided
INCLUSION CRITERIA
To be included in this study, subjects must meet the following criteria:
EXCLUSION CRITERIA
Subjects will be excluded from the study if they present with any of the following:
Subjects excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deepak L. Bhatt, MD | The Cleveland Clinic | Principal Investigator |
| Robert A. Harrington, MD | Duke University Medical Center and Duke Clinical Research Institute | Principal Investigator |
| Simona Skerjanec, PharmD | The Medicines Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107-6192 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19915221 | Result | Harrington RA, Stone GW, McNulty S, White HD, Lincoff AM, Gibson CM, Pollack CV Jr, Montalescot G, Mahaffey KW, Kleiman NS, Goodman SG, Amine M, Angiolillo DJ, Becker RC, Chew DP, French WJ, Leisch F, Parikh KH, Skerjanec S, Bhatt DL. Platelet inhibition with cangrelor in patients undergoing PCI. N Engl J Med. 2009 Dec 10;361(24):2318-29. doi: 10.1056/NEJMoa0908628. | |
| 38551015 |
Not provided
Not provided
Not provided
Patients were selected for randomization based on the need for percutaneous coronary intervention (PCI). Randomization could only occur after the need for PCI was confirmed by angiography, with the exception of ST-segment elevation myocardial infarction (STEMI) patients, who could be enrolled upon confirmation of STEMI by electrocardiogram (ECG).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cangrelor Arm | cangrelor arm: placebo capsules at PCI start + cangrelor bolus(30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion |
| FG001 | Clopidogrel Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 48 Hour Follow-up Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| clopidogrel (oral P2Y12 inhibitor) | Drug | 600 mg active clopidogrel administered as soon as possible following randomization (after need for PCI confirmed), but not more than 30 minutes prior to the placement of the arterial access. |
|
|
| Placebo bolus & placebo infusion | Drug | placebo bolus (30 mcg/kg) & placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) |
|
| Placebo capsules - end of infusion | Drug | Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing |
|
| Placebo capsules - as soon as possible after randomization | Drug | Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing |
|
| Individual Incidence of IDR | randomization through 48 hours after randomization |
| Incidence of Stroke | Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as:
| randomization through 48 hours after randomization |
| Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI | (a patient could have multiple procedural events) | during index PCI |
| Incidence of All-cause Mortality, MI or IDR | (composite incidence) | randomization through 30 days after randomization |
| Incidence of All-cause Mortality or MI | (composite incidence) | randomization through 30 days after randomization |
| Incidence of All-cause Mortality | randomization through 30 days after randomization |
| Incidence of MI | randomization through 30 days after randomization |
| Incidence of IDR | randomization through 30 days after randomization |
| Incidence of Stroke | randomization through 30 days after randomization |
| Incidence of All Cause Mortality | (excluding STEMI) | randomization through 1 year after randomization |
| Incidence of GUSTO Severe / Life-threatening Bleeding | Major bleeding (non-CABG-related) - Safety population | randomization through 48 hours after randomization |
| Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Major bleeding (non-CABG-related) - Safety population | randomization through 48 hours after randomization |
| Incidence of ACUITY Major Bleeding | Major bleeding (non-CABG-related) - Safety population | randomization through 48 hours after randomization |
| Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm) | excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm | randomization through 48 hours after randomization |
| 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 | 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. |
| 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. |
| 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. |
| 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. |
| 22305835 | Derived | White HD, Chew DP, Dauerman HL, Mahaffey KW, Gibson CM, Stone GW, Gruberg L, Harrington RA, Bhatt DL. Reduced immediate ischemic events with cangrelor in PCI: a pooled analysis of the CHAMPION trials using the universal definition of myocardial infarction. Am Heart J. 2012 Feb;163(2):182-90.e4. doi: 10.1016/j.ahj.2011.11.001. |
clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion followed by placebo capsules post infusion
| Intent-to-treat (ITT): SA/UA/NSTEMI |
|
| Intent-to-treat (ITT): STEMI |
|
| Modified ITT (mITT): SA/UA/NSTEMI |
|
| Modified ITT (mITT): STEMI |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| 30-day Follow-up Period |
|
| 1 Year Follow-up Period |
|
Intent-to-treat (ITT) population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cangrelor Arm | cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion |
| BG001 | Clopidogrel Arm | clopidogrel arm: clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion |
| 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 |
| ||||||||||||||||
| 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 | Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) | (composite incidence) | mITT (excluding STEMI) | Posted | Number | participants | randomization through 48 hours after randomization |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of All-cause Mortality and MI | (composite incidence) | mITT (excluding STEMI) | Posted | Number | participants | randomization through 48 hours after randomization |
|
| ||||||||||||||||||||||||||||||
| Secondary | Individual Incidence of All-cause Mortality | mITT (excluding STEMI) | Posted | Number | participants | randomization through 48 hours after randomization |
|
| |||||||||||||||||||||||||||||||
| Secondary | Individual Incidence of IDR | mITT (excluding STEMI) | Posted | Number | participants | randomization through 48 hours after randomization |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Stroke | Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as:
| mITT (excluding STEMI) | Posted | Number | participants | randomization through 48 hours after randomization |
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI | (a patient could have multiple procedural events) | mITT (excluding STEMI) and based on available data | Posted | Number | participants | during index PCI |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of All-cause Mortality, MI or IDR | (composite incidence) | mITT (excluding STEMI), based on 30-day completers | Posted | Number | participants | randomization through 30 days after randomization |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of All-cause Mortality or MI | (composite incidence) | mITT (excluding STEMI), based on 30-day completers | Posted | Number | participants | randomization through 30 days after randomization |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of All-cause Mortality | mITT (excluding STEMI), based on 30-day completers | Posted | Number | participants | randomization through 30 days after randomization |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of MI | mITT (excluding STEMI), based on 30-day completers | Posted | Number | participants | randomization through 30 days after randomization |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of IDR | mITT (excluding STEMI), based on 30-day completers | Posted | Number | participants | randomization through 30 days after randomization |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Stroke | mITT (excluding STEMI), based on available data | Posted | Number | participants | randomization through 30 days after randomization |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of All Cause Mortality | (excluding STEMI) | mITT (excluding STEMI), based on 1 year completers | Posted | Number | participants | randomization through 1 year after randomization |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of GUSTO Severe / Life-threatening Bleeding | Major bleeding (non-CABG-related) - Safety population | Safety Population (inclusive of STEMI patients) | Posted | Number | participants | randomization through 48 hours after randomization |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Major bleeding (non-CABG-related) - Safety population | Safety Population (inclusive of STEMI patients) | Posted | Number | participants | randomization through 48 hours after randomization |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of ACUITY Major Bleeding | Major bleeding (non-CABG-related) - Safety population | Safety Population (inclusive of STEMI patients) | Posted | Number | participants | randomization through 48 hours after randomization |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm) | excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm | Safety Population (inclusive of STEMI patients) | Posted | Number | participants | randomization through 48 hours after randomization |
|
|
Not provided
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 Arm | cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion | 125 | 4,374 | 1,149 | 4,374 | ||
| EG001 | Clopidogrel Arm | clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion | 127 | 4,365 | 1,159 | 4,365 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaemia | Blood and lymphatic system disorders |
| |||
| haemolytic anaemia | Blood and lymphatic system disorders |
| |||
| haemorrhagic anaemia | Blood and lymphatic system disorders |
| |||
| leukocytosis | Blood and lymphatic system disorders |
| |||
| thrombocytopenia | Blood and lymphatic system disorders |
| |||
| acute myocardial infarction | Cardiac disorders |
| |||
| angina pectoris | Cardiac disorders |
| |||
| arrhythmia | Cardiac disorders |
| |||
| arrhythmia supraventricular | Cardiac disorders |
| |||
| arteriospasm coronary | Cardiac disorders |
| |||
| atrial fibrillation | Cardiac disorders |
| |||
| atrial flutter | Cardiac disorders |
| |||
| atrial tachycardia | Cardiac disorders |
| |||
| atrioventricular block | Cardiac disorders |
| |||
| atrioventricular block third degree | 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 |
| |||
| cardiogenic shock | Cardiac disorders |
| |||
| coronary artery dissection | Cardiac disorders |
| |||
| coronary artery occlusion | Cardiac disorders |
| |||
| coronary artery perforation | Cardiac disorders |
| |||
| coronary artery thrombosis | Cardiac disorders |
| |||
| in-stent arterial restenosis | Cardiac disorders |
| |||
| myocardial infarction | Cardiac disorders |
| |||
| nodal rhythm | Cardiac disorders |
| |||
| pericardial effusion | Cardiac disorders |
| |||
| sick sinus syndrome | Cardiac disorders |
| |||
| sinus arrest | Cardiac disorders |
| |||
| supraventricular tachycardia | Cardiac disorders |
| |||
| ventricular arrhythmia | Cardiac disorders |
| |||
| ventricular asystole | Cardiac disorders |
| |||
| ventricular fibrillation | Cardiac disorders |
| |||
| ventricular tachycardia | Cardiac disorders |
| |||
| retinal artery occlusion | Eye disorders |
| |||
| abdominal pain upper | Gastrointestinal disorders |
| |||
| haematemesis | Gastrointestinal disorders |
| |||
| retroperitoneal haemorrhage | Gastrointestinal disorders |
| |||
| vomiting | Gastrointestinal disorders |
| |||
| cardiac death | General disorders |
| |||
| chest discomfort | General disorders |
| |||
| chest pain | General disorders |
| |||
| non-cardiac chest pain | General disorders |
| |||
| puncture site haemorrhage | General disorders |
| |||
| pyrexia | General disorders |
| |||
| sudden cardiac death | General disorders |
| |||
| sudden death | General disorders |
| |||
| vessel puncture site haematoma | General disorders |
| |||
| cholecystitis acute | Hepatobiliary disorders |
| |||
| gallbladder disorder | Hepatobiliary disorders |
| |||
| bronchitis | Infections and infestations |
| |||
| bronchitis viral | Infections and infestations |
| |||
| cellulitis | Infections and infestations |
| |||
| haematoma infection | Infections and infestations |
| |||
| pneumonia | Infections and infestations |
| |||
| sepsis | Infections and infestations |
| |||
| urinary tract infection | Infections and infestations |
| |||
| fibula fracture | Injury, poisoning and procedural complications |
| |||
| thrombosis in device | Injury, poisoning and procedural complications |
| |||
| vascular procedure complication | Injury, poisoning and procedural complications |
| |||
| aspartate aminotransferase increased | Investigations |
| |||
| cardiac enzymes increased | Investigations |
| |||
| liver function test abnormal | Investigations |
| |||
| gout | Metabolism and nutrition disorders |
| |||
| hypoglycaemia | Metabolism and nutrition disorders |
| |||
| back pain | Musculoskeletal and connective tissue disorders |
| |||
| musculoskeletal pain | Musculoskeletal and connective tissue disorders |
| |||
| cerebral haemorrhage | Nervous system disorders |
| |||
| diabetic neuropathy | Nervous system disorders |
| |||
| presyncope | Nervous system disorders |
| |||
| syncope | Nervous system disorders |
| |||
| alcohol withdrawal syndrome | Psychiatric disorders |
| |||
| depression | Psychiatric disorders |
| |||
| mental status changes | Psychiatric disorders |
| |||
| renal artery stenosis | Renal and urinary disorders |
| |||
| renal failure | Renal and urinary disorders |
| |||
| renal failure acute | Renal and urinary disorders |
| |||
| renal failure chronic | Renal and urinary disorders |
| |||
| acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders |
| |||
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
| |||
| dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| pulmonary congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
| |||
| pulmonary oedema | Respiratory, thoracic and mediastinal disorders |
| |||
| respiratory distress | Respiratory, thoracic and mediastinal disorders |
| |||
| respiratory failure | Respiratory, thoracic and mediastinal disorders |
| |||
| angioneurotic oedema | Skin and subcutaneous tissue disorders |
| |||
| stent removal | Surgical and medical procedures |
| |||
| arterial thrombosis limb | Vascular disorders |
| |||
| artery dissection | Vascular disorders |
| |||
| embolism | Vascular disorders |
| |||
| femoral artery dissection | Vascular disorders |
| |||
| femoral artery occlusion | Vascular disorders |
| |||
| haemodynamic instability | Vascular disorders |
| |||
| hypertension | Vascular disorders |
| |||
| hypertensive emergency | Vascular disorders |
| |||
| hypotension | Vascular disorders |
| |||
| orthostatic hypotension | Vascular disorders |
| |||
| peripheral ischaemia | Vascular disorders |
| |||
| reperfusion injury | Vascular disorders |
| |||
| shock haemorrhagic | Vascular disorders |
| |||
| thrombosis | Vascular disorders |
| |||
| vascular pseudoaneurysm | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chest pain | General disorders |
| |||
| back pain | Musculoskeletal and connective tissue disorders |
| |||
| nausea | Gastrointestinal disorders |
| |||
| hypotension | Vascular disorders |
| |||
| headache | Nervous system disorders |
| |||
| vomiting | Gastrointestinal disorders |
| |||
| puncture site pain | General disorders |
| |||
| pyrexia | General disorders |
| |||
| dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| ventricular tachycardia | Cardiac disorders |
| |||
| hypertension | Vascular disorders |
| |||
| chest discomfort | General disorders |
| |||
| bradycardia | Cardiac disorders |
| |||
| atrial fibrillation | Cardiac disorders |
| |||
| angina pectoris | Cardiac disorders |
| |||
| pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| syncope vasovagal | Nervous system disorders |
| |||
| musculoskeletal pain | Musculoskeletal and connective tissue disorders |
| |||
| dizziness | Nervous system disorders |
| |||
| anxiety | Psychiatric disorders |
| |||
| dyspepsia | Gastrointestinal disorders |
|
Discontinued per prespecified stopping rules after the 70% interim analyses was conducted indicating the trial was not likely to meet the goal of demonstrating superiority to clopidogrel administered as usual care. No safety issues were identified.
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 40 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 | The Medicines Company | +19732906088 | meredith.todd@themedco.com |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C117446 | cangrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| 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
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