Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).
This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptifibatide | Experimental | Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin. |
|
| Placebo | Placebo Comparator | Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptifibatide (Integrilin) | Drug | intravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG [coronary artery bypass graft]); second bolus of 180 mcg/kg administered 10 minutes after first bolus. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. | 96 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the Composite of Death/MI. | 30 days after randomization |
Not provided
Inclusion Criteria:
Willing and able to give informed consent and comply with study procedures and follow-up through 1 year.
Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours.
Able to be randomized into the trial within 12 hours of having symptoms of acute coronary syndrome.
Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes and have at least 2 of the following:
Or have all 3 of the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35224730 | Derived | Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4. | |
| 31976867 | Derived | Furtado RHM, Nicolau JC, Guo J, Im K, White JA, Sabatine MS, Newby LK, Giugliano RP. Morphine and Cardiovascular Outcomes Among Patients With Non-ST-Segment Elevation Acute Coronary Syndromes Undergoing Coronary Angiography. J Am Coll Cardiol. 2020 Jan 28;75(3):289-300. doi: 10.1016/j.jacc.2019.11.035. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients in both treatment groups who were undergoing PCI could receive unblinded eptifibatide provisionally immediately before or during percutaneous coronary intervention (PCI) at the discretion of the investigator.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Eptifibatide | Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin. |
| FG001 | Placebo | Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Drug | intravenous; delivery to match eptifibatide to maintain blind |
|
| 28089149 | Derived | Farhan S, Clare RM, Jarai R, Giugliano RP, Lokhnygina Y, Harrington RA, Kristin Newby L, Huber K. Fasting glucose, NT-proBNP, treatment with eptifibatide, and outcomes in non-ST-segment elevation acute coronary syndromes: An analysis from EARLY ACS. Int J Cardiol. 2017 Apr 1;232:264-270. doi: 10.1016/j.ijcard.2017.01.007. Epub 2017 Jan 4. |
| 26957532 | Derived | Kragholm K, Goldstein SA, Yang Q, Lopes RD, Schulte PJ, Bernacki GM, White HD, Mahaffey KW, Giugliano RP, Armstrong PW, Harrington RA, Tricoci P, Van de Werf F, Alexander JH, Alexander KP, Newby LK. Trends in Enrollment, Clinical Characteristics, Treatment, and Outcomes According to Age in Non-ST-Segment-Elevation Acute Coronary Syndromes Clinical Trials. Circulation. 2016 Apr 19;133(16):1560-73. doi: 10.1161/CIRCULATIONAHA.115.017299. Epub 2016 Mar 8. |
| 24607027 | Derived | Kunadian V, Giugliano RP, Newby LK, Zorkun C, Guo J, Bagai A, Montalescot G, Braunwald E, Califf RM, Van de Werf F, Armstrong PW, Harrington R, Gibson CM. Angiographic outcomes with early eptifibatide therapy in non-ST-segment elevation acute coronary syndrome (from the EARLY ACS Trial). Am J Cardiol. 2014 Apr 15;113(8):1297-305. doi: 10.1016/j.amjcard.2014.01.404. Epub 2014 Jan 31. |
| 24562802 | Derived | De Ferrari GM, Fox KA, White JA, Giugliano RP, Tricoci P, Reynolds HR, Hochman JS, Gibson CM, Theroux P, Harrington RA, Van de Werf F, White HD, Califf RM, Newby LK. Outcomes among non-ST-segment elevation acute coronary syndromes patients with no angiographically obstructive coronary artery disease: observations from 37,101 patients. Eur Heart J Acute Cardiovasc Care. 2014 Mar;3(1):37-45. doi: 10.1177/2048872613489315. Epub 2013 May 9. |
| 24093853 | Derived | Kaul P, Tanguay JF, Newby LK, Hochman JS, Westerhout CM, Califf RM, Tricoci P, Gibson CM, Giugliano RP, Harrington RA, Van de Werf F, Armstrong PW. Association between bleeding and mortality among women and men with high-risk acute coronary syndromes: insights from the Early versus Delayed, Provisional Eptifibatide in Acute Coronary Syndromes (EARLY ACS) trial. Am Heart J. 2013 Oct;166(4):723-8. doi: 10.1016/j.ahj.2013.07.014. Epub 2013 Sep 5. |
| 24016495 | Derived | Bagai A, White JA, Lokhnygina Y, Giugliano RP, Van de Werf F, Montalescot G, Armstrong PW, Tricoci P, Gibson CM, Califf RM, Harrington RA, Newby LK. Routine early eptifibatide versus delayed provisional use at percutaneous coronary intervention in high-risk non-ST-segment elevation acute coronary syndromes patients: an analysis from the Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome trial. Am Heart J. 2013 Sep;166(3):466-73. doi: 10.1016/j.ahj.2013.05.019. Epub 2013 Jul 25. |
| 23537976 | Derived | Klutstein MW, Westerhout CM, Armstrong PW, Giugliano RP, Lewis BS, Gibson CM, Lutchmedial S, Widimsky P, Steg PG, Dalby A, Zeymer U, Van de Werf F, Harrington RA, Newby LK, Rao SV. Radial versus femoral access, bleeding and ischemic events in patients with non-ST-segment elevation acute coronary syndrome managed with an invasive strategy. Am Heart J. 2013 Apr;165(4):583-590.e1. doi: 10.1016/j.ahj.2013.01.009. Epub 2013 Feb 22. |
| 23416014 | Derived | Ezekowitz JA, Bakal JA, Westerhout CM, Giugliano RP, White H, Keltai M, Prabhakaran D, Tricoci P, Van de Werf F, Califf RM, Newby LK, Armstrong PW. The relationship between meteorological conditions and index acute coronary events in a global clinical trial. Int J Cardiol. 2013 Oct 3;168(3):2315-21. doi: 10.1016/j.ijcard.2013.01.061. Epub 2013 Feb 14. |
| 22995880 | Derived | Pride YB, Mohanavelu S, Zorkun C, Kunadian V, Giugliano RP, Newby LK, Braunwald E, Califf RM, Harrington RA, Gibson CM; EARLY ACS Investigators. Association between angiographic complications and clinical outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention: an EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome) angiographic substudy. JACC Cardiovasc Interv. 2012 Sep;5(9):927-35. doi: 10.1016/j.jcin.2012.05.007. |
| 22645292 | Derived | Piccini JP, White JA, Mehta RH, Lokhnygina Y, Al-Khatib SM, Tricoci P, Pollack CV Jr, Montalescot G, Van de Werf F, Gibson CM, Giugliano RP, Califf RM, Harrington RA, Newby LK. Sustained ventricular tachycardia and ventricular fibrillation complicating non-ST-segment-elevation acute coronary syndromes. Circulation. 2012 Jul 3;126(1):41-9. doi: 10.1161/CIRCULATIONAHA.111.071860. Epub 2012 May 29. |
| 22373905 | Derived | Roe MT, White JA, Kaul P, Tricoci P, Lokhnygina Y, Miller CD, van't Hof AW, Montalescot G, James SK, Saucedo J, Ohman EM, Pollack CV Jr, Hochman JS, Armstrong PW, Giugliano RP, Harrington RA, Van de Werf F, Califf RM, Newby LK. Regional patterns of use of a medical management strategy for patients with non-ST-segment elevation acute coronary syndromes: insights from the EARLY ACS Trial. Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):205-13. doi: 10.1161/CIRCOUTCOMES.111.962332. Epub 2012 Feb 28. |
| 21300952 | Derived | Wang TY, White JA, Tricoci P, Giugliano RP, Zeymer U, Harrington RA, Montalescot G, James SK, Van de Werf F, Armstrong PW, Braunwald E, Califf RM, Newby LK. Upstream clopidogrel use and the efficacy and safety of early eptifibatide treatment in patients with acute coronary syndrome: an analysis from the Early Glycoprotein IIb/IIIa Inhibition in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome (EARLY ACS) trial. Circulation. 2011 Feb 22;123(7):722-30. doi: 10.1161/CIRCULATIONAHA.110.958041. Epub 2011 Feb 7. |
| 19332455 | Derived | Giugliano RP, White JA, Bode C, Armstrong PW, Montalescot G, Lewis BS, van 't Hof A, Berdan LG, Lee KL, Strony JT, Hildemann S, Veltri E, Van de Werf F, Braunwald E, Harrington RA, Califf RM, Newby LK; EARLY ACS Investigators. Early versus delayed, provisional eptifibatide in acute coronary syndromes. N Engl J Med. 2009 May 21;360(21):2176-90. doi: 10.1056/NEJMoa0901316. Epub 2009 Mar 30. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eptifibatide | Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin. |
| BG001 | Placebo | Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin. |
| 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 the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. | Intent to treat population | Posted | Number | percentage of participants | 96 hours after randomization |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of the Composite of Death/MI. | Intent to treat population | Posted | Number | percentage of participants | 30 days after randomization |
|
|
Through hospital discharge or 120 hours after randomization, whichever occurred first.
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 | Eptifibatide | Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin. | 66 | 4,686 | 0 | 4,686 | ||
| EG001 | Placebo | Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin. | 60 | 4,643 | 0 | 4,643 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| MICROCYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| MIDDLE EAR INFLAMMATION | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ADRENOCORTICAL INSUFFICIENCY ACUTE | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
| |
| OPHTHALMOPLEGIA | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| RETINAL ARTERY OCCLUSION | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| DIVERTICULUM INTESTINAL | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| GASTRIC PERFORATION | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| OESOPHAGEAL ULCER | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| IMPLANT SITE EFFUSION | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ABDOMINAL SEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| HEPATITIS A | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| LOBAR PNEUMONIA | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| PERIRECTAL ABSCESS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| MEDICATION ERROR | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO DECREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| GASTROINTESTINAL TRACT ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PARKINSONISM | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| VASCULAR ENCEPHALOPATHY | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| HALLUCINATION | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| IGA NEPHROPATHY | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| NEPHRITIS INTERSTITIAL | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| NEPHROPATHY TOXIC | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| NEPHROSCLEROSIS | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| RENAL FAILURE CHRONIC | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| RENAL INFARCT | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ANOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PLEURAL FISTULA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PULMONARY CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| AORTIC DISSECTION | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PERIPHERAL EMBOLISM | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| D000787 | Angina Pectoris |
| D007511 | Ischemia |
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077542 | Eptifibatide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
|