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| Name | Class |
|---|---|
| SCRI Development Innovations, LLC | OTHER |
Not provided
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The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of death, PCI-related myocardial infarction, urgent target vessel revascularization or in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Tirofiban (Aggrastat) | Experimental | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). |
|
| Eptifibatide (Integrilin) | Active Comparator | Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first. Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). |
|
| Long Tirofiban (Aggrastat) | Experimental | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Tirofiban | Drug | 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria. | 48 hours or hospital discharge, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), or urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven V Manoukian, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osceola Regional Medical Center | Kissimmee | Florida | 34741 | United States | ||
| Northside Hospital |
Decision to proceed to PCI, access site for PCI (transradial or transfemoral) and intended oral P2Y12 antagonist agent used post-randomization were all pre-specified prior to randomization to treatment groups.
Date first patient enrolled: 12 June 2012 ; Last patient completed 8 August 2018
The study enrolled both stable and UA/NSTEMI patients scheduled to undergo PCI in one or more native coronary target lesions.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Short Tirofiban (Aggrastat) | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2018 | Mar 25, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Eptifibatide | Drug | 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first. |
|
|
| Long Tirofiban | Drug | 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI. |
|
|
| 48 hours or hospital discharge, whichever came first |
| Individual Components of Death, Urgent Target Revascularization or Major Bleeding | Individual components of death (any-cause), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 major bleeding criteria. | 48 hours or hospital discharge, whichever came first |
| Individual Components of Periprocedural Myonecrosis | Individual components of periprocedural myonecrosis (PPM) (defined as ≥ 3 times, ≥ 10 times, ≥ 20 times or ≥ 50 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value) | 48 hours or hospital discharge, whichever came first |
| The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 10 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria. | 48 hours or hospital discharge, whichever came first |
| St. Petersburg |
| Florida |
| 33709 |
| United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| North Georgia Heart Center | Gainesville | Georgia | 30501 | United States |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | United States |
| Archbold Medical Center | Thomasville | Georgia | 31792 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Centennial Heart | Nashville | Tennessee | 37203 | United States |
| Chippenham Hospital | Richmond | Virginia | 23225 | United States |
| FG001 | Eptifibatide (Integrilin) | Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first. Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first. |
| FG002 | Long Tirofiban (Aggrastat) | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI. |
| COMPLETED |
|
| NOT COMPLETED |
|
Modified intention-to-treat (mITT) - all randomized patients who underwent PCI and received study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Short Tirofiban (Aggrastat) | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI. |
| BG001 | Eptifibatide (Integrilin) | Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first. Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first. |
| BG002 | Long Tirofiban (Aggrastat) | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI. |
| BG003 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria. | As per the protocol, a patient must have a pre-PCI troponin measurement and at least one troponin measurement within 48 hours following PCI or hospital discharge, whichever comes first, otherwise they were excluded from the primary composite endpoint. | Posted | Count of Participants | Participants | 48 hours or hospital discharge, whichever came first |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), or urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) | As per the protocol, a patient must have a pre-PCI troponin measurement and at least one troponin measurement within 48 hours following PCI or hospital discharge, whichever comes first, otherwise they were excluded from the primary composite endpoint. | Posted | Count of Participants | Participants | 48 hours or hospital discharge, whichever came first |
| ||||||||||||||||||||||||||||||||||
| Secondary | Individual Components of Death, Urgent Target Revascularization or Major Bleeding | Individual components of death (any-cause), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 major bleeding criteria. | mITT | Posted | Count of Participants | Participants | 48 hours or hospital discharge, whichever came first |
| ||||||||||||||||||||||||||||||||||
| Secondary | Individual Components of Periprocedural Myonecrosis | Individual components of periprocedural myonecrosis (PPM) (defined as ≥ 3 times, ≥ 10 times, ≥ 20 times or ≥ 50 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value) | As per the protocol, a patient must have a pre-PCI troponin measurement and at least one troponin measurement within 48 hours following PCI or hospital discharge, whichever comes first, otherwise they were excluded from the individual PPM endpoints. | Posted | Count of Participants | Participants | 48 hours or hospital discharge, whichever came first |
| ||||||||||||||||||||||||||||||||||
| Secondary | The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 10 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria. | Posted | Count of Participants | Participants | 48 hours or hospital discharge, whichever came first |
|
48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
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 | Short Tirofiban (Aggrastat) | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI. | 0 | 209 | 8 | 209 | 45 | 209 |
| EG001 | Eptifibatide (Integrilin) | Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first. Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first. | 1 | 202 | 11 | 202 | 55 | 202 |
| EG002 | Long Tirofiban (Aggrastat) | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI. | 0 | 124 | 7 | 124 | 50 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery Dissection | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Post-Procedural Myocardial Infarction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Hypertensive Crisis | Vascular disorders | Systematic Assessment |
| ||
| Vessel Perforation | Vascular disorders | Systematic Assessment |
| ||
| Gastrointestinal Angiodysplasia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Inflammation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Vision Blurred | Eye disorders | Systematic Assessment |
| ||
| Contrast Media Allergy | Immune system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Thrombosis in Device | Product Issues | Systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Testicular Haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter Site Haematoma | General disorders | Systematic Assessment |
| ||
| Application Site Haemorrhage | General disorders | Systematic Assessment |
| ||
| Infusion Site Haematoma | General disorders | Systematic Assessment |
| ||
| Non-Cardiac Chest Pain | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Vessel Puncture Site Haematoma | General disorders | Systematic Assessment |
| ||
| Vessel Puncture Site Haemorrhage | General disorders | Systematic Assessment |
| ||
| Troponin Increased | Investigations | Systematic Assessment |
| ||
| Haematocrit Decreased | Investigations | Systematic Assessment |
| ||
| Troponin T Increased | Investigations | Systematic Assessment |
| ||
| Blood Creatinine Increased | Investigations | Systematic Assessment |
| ||
| Blood Glucose Decreased | Investigations | Systematic Assessment |
| ||
| Occult Blood Positive | Investigations | Systematic Assessment |
| ||
| Troponin I Increased | Investigations | Systematic Assessment |
| ||
| Angina Pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery Dissection | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Intracardiac Thrombus | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Post Procedural Myocardial Infarction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision Site Haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision Site Haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound Secretion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Graft Haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Mental Status Change Postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Vascular Dissection | Vascular disorders | Systematic Assessment |
| ||
| Embolism | Vascular disorders | Systematic Assessment |
| ||
| Hypertensive Crisis | Vascular disorders | Systematic Assessment |
| ||
| Vessel Perforation | Vascular disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Angiodysplasia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Inflammation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epitaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Groin Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Patellofemoral Pain Syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephropathy | Renal and urinary disorders | Systematic Assessment |
| ||
| Eye Pain | Eye disorders | Systematic Assessment |
| ||
| Ocular Hyperaemia | Eye disorders | Systematic Assessment |
| ||
| Vision Blurred | Eye disorders | Systematic Assessment |
| ||
| Dizziness | Eye disorders | Systematic Assessment |
| ||
| Neurological Decompensation | Nervous system disorders | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Contrast Media Allergy | Immune system disorders | Systematic Assessment |
| ||
| Thrombosis in Device | Product Issues | Systematic Assessment |
| ||
| Testicular Haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Petechiae | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Randomization into the long tirofiban arm was initiated after 159 patients were already enrolled into either the short tirofiban or long eptifibatide arms.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyle Brown | Medicure | 204-594-3411 | kbrown@medicure.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2019 | Mar 25, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| D000789 | Angina, Unstable |
| 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 |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| D000077542 | Eptifibatide |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Long Tirofiban (Aggrastat) | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI. |
|
|
| OG002 | Long Tirofiban (Aggrastat) | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI. |
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| OG002 | Long Tirofiban (Aggrastat) | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI. |
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| OG002 | Long Tirofiban (Aggrastat) | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI. |
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