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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The primary objective of this study is to gather preliminary data regarding the angiographic efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during balloon angioplasty for heart attacks.
We hypothesize that low-dose IC tenecteplase will enhance the breakdown of blood clots at the site of the culprit lesion leading to reduced damage to the heart muscle.
The primary objective of this study is to gather preliminary data regarding the angiographic efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Efficacy will be assessed by measurements of both the angiographic characteristics of the culprit lesion as well as by measurements of epicardial flow and myocardial perfusion in the territory of the infarct-related artery. This study will also evaluate the safety of administering low-dose IC tenecteplase to subjects undergoing primary PCI for STEMI treated with standard therapy (aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitors). Safety endpoints include the incidence of death, recurrent myocardial infarction (MI), abrupt vessel closure, subacute stent thrombosis, and TIMI major and minor bleeding events.
Prompt reperfusion therapy with primary PCI in patients with STEMI improves clinical outcomes through salvage of myocardial tissue. The proposed pilot trial is a randomized, placebo-controlled trial to evaluate the effectiveness and safety of adjunctive low-dose IC tenecteplase in conjunction with standard medical therapy during primary PCI for STEMI. We hypothesized that low-dose IC tenecteplase will enhance fibrinolysis at the site of the culprit lesion leading to reduced microvascular dysfunction. As reduced dose tenecteplase will be injected directly into the coronary artery increasing local concentration of the drug with minor systemic effects, an improved safety profile is also expected from this mode of administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Two (4mg) doses of tenecteplase |
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| 2 | Placebo Comparator | Two (4mL) doses of sterile saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug | Intracoronary injection of IV tenecteplase. |
| |
| Sterile Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention | Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention | Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention | |
| Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug |
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Inclusion Criteria:
Exclusion Criteria:
CLINICAL
BIOCHEMICAL
INCREASED BLEEDING RISK
MEDICATIONS
ANGIOGRAPHIC
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| Name | Affiliation | Role |
|---|---|---|
| C. Michael Gibson, MS, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Georgia Heart Center, PC | Gainesville | Florida | 30501 | United States | ||
| Emory University Hospital Midtown |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31870492 | Derived | Gibson CM, Kumar V, Gopalakrishnan L, Singh P, Guo J, Kazziha S, Devireddy C, Pinto D, Marshall JJ, Stouffer GA, Mavromatis K, Grip L, Bainey KR; TIMI & PERFUSE Study Group. Feasibility and Safety of Low-Dose Intra-Coronary Tenecteplase During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (ICE T-TIMI 49). Am J Cardiol. 2020 Feb 15;125(4):485-490. doi: 10.1016/j.amjcard.2019.11.018. Epub 2019 Nov 20. |
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The study randomized 40 primary percutaneous coronary intervention (PPCI) patients from 6 hospitals in the United States. The patients were given either a volume matched bolus of intracoronary (IC) tenecteplase (TNK) (4 mg; n=20) or IC saline placebo (4 mg; n=16) before and following PPCI. 4 subjects were randomized but did not receive 1st bolus.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | Two (4mg) doses of tenecteplase |
| FG001 | Placebo Control | Two (4mL) doses of sterile saline |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
Intracoronary injection of IV sterile saline |
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Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the territory of the culprit artery |
| Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug |
| Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) | Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery | Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug |
| Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14 | Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14 | Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug |
| Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding | Through 30days following PPCI |
| Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding | Through 30days following primary percutaneous coronary intervention |
| Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias | Through 30days following primary percutaneous coronary intervention |
| Safety Endpoint: Number of Deaths | Through 30days following primary percutaneous coronary intervention |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Emory University | Decatur | Georgia | 30033 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Crittenton Hospital Medical Center | Rochester | Michigan | 48307 | United States |
| Heart Consultants, PC | Freemont | Nebraska | 68025 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Two (4mg) doses of tenecteplase |
| BG001 | Placebo Control | Two (4mL) doses of sterile saline |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention | Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1. Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. | Posted | Median | Inter-Quartile Range | Percent diameter stenosis | Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention |
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| Secondary | Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention | Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1. Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. | Posted | Number | participants | Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention |
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| Secondary | Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug | Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the territory of the culprit artery | Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1. Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. | Posted | Number | participants | Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug |
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| Secondary | Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) | Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery | Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients | Posted | Median | Inter-Quartile Range | Corrected TIMI Frame Count (cTFC) | Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug |
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| Secondary | Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14 | Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14 | Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients | Posted | Number | participants | Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug |
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| Secondary | Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) | Posted | Number | participants | Through 30days following PPCI |
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| Secondary | Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) | Posted | Number | participants | Through 30days following primary percutaneous coronary intervention |
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| Secondary | Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) | Posted | Number | participants | Through 30days following primary percutaneous coronary intervention |
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| Secondary | Safety Endpoint: Number of Deaths | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) | Posted | Number | participants | Through 30days following primary percutaneous coronary intervention |
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30-days following primary percutaneous coronary intervention
Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | Two (4mg) doses of tenecteplase | 2 | 20 | 14 | 20 | ||
| EG001 | Placebo Control | Two (4mL) doses of sterile saline | 1 | 16 | 11 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erosive Gastritis | Gastrointestinal disorders | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Dressler's syndrome | Cardiac disorders | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Death | General disorders | Cause of death unknown. Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Pre-existing anemia. Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Ventricular Tachycardia | Cardiac disorders | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Pancreatitis | Gastrointestinal disorders | Pre-existing chronic pancreatitis. Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Incision site pain | Injury, poisoning and procedural complications | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Clostridium difficile infection | Infections and infestations | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Right hand and finger numbness | Injury, poisoning and procedural complications | Primary percutaneous coronary intervention was performed via radial approach. Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Right groin cellulitis | Injury, poisoning and procedural complications | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Urinary tract infection | Infections and infestations | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Pre-existing asthma. Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Allergic reaction to Bactrim | Immune system disorders | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Allergic reaction to Lisinopril | Immune system disorders | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Bleeding | Injury, poisoning and procedural complications | Bleeding at the site of insertion of catheter. Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Hypotension | Cardiac disorders | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Chest pain | Cardiac disorders | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| Back pain | General disorders | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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| High grade Atrio-Ventricular Block | Cardiac disorders | Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo). |
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This pilot study was not adequately powered to exclude a modest increase in bleeding events. Study drug could not be administered to 4 patients and 7 patients were excluded for not meeting the inclusion criteria of TIMI Flow Grade 0/1 at enrollment.
Principal Investigator shall furnish Sponsor with copy of any proposed publication for review/comment prior to submission for publication, at least thirty (30) days prior to submission for manuscripts and at least fifteen (15) days prior to submission for abstracts. Institution agrees to delete information identified by Sponsor as Confidential Information prior to submission for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| C. Michael Gibson, MS, MD | Brigham & Women's Hospital | 617-632-7753 | mgibson@perfuse.org |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| 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 |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| >=65 years |
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| Male |
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