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This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in patients with ST-elevation myocardial infarction randomized to receive cangrelor during their percutaneous coronary intervention and compares them to patients randomized to not receive cangrelor.
Cangrelor is a direct-acting and reversible intravenously administered platelet inhibitor approved as an adjunct to percutaneous intervention (PCI) for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis. As it has a quick onset of action (2 minutes) compared to traditional oral platelet inhibitors, cangrelor is emerging as an important new option for use in patients undergoing percutaneous intervention who have not been treated with oral platelet inhibitors.
Furthermore, multiple studies have demonstrated that patients with ST-elevation myocardial infarction (STEMI) who undergo emergent PCI do not have optimal platelet inhibition even after administration of a loading dose of traditional oral platelet inhibitors. However, the clinical significance of complete platelet inhibition around the time of PCI is not fully understood.
The primary objective is to characterize the utility of immediate platelet inhibition with intravenous cangrelor in patients presenting with an acute STEMI by assessing the extent of infarct size (either enzymatically or by imaging). If the findings are favorable, this may suggest that immediate platelet inhibition is an important part of care in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cangrelor | Experimental | Approximately 30 patients in this arm will receive standard STEMI care but will also receive standard dosing of cangrelor at the time of their PCI. |
|
| No cangrelor | No Intervention | Approximately 30 patients in this arm will receive standard STEMI but will not receive cangrelor at the time of their PCI. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cangrelor | Drug | Cangrelor 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion prior to PCI will be given. It will be continued for ≥ 2 hours or for the duration of the procedure, whichever is longer. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Myocardial Infarction Size | Cardiac MRI is obtained at 48 hours and 3 months to compare differences in infarct size. The outcome is assessed as the difference in infarct size between 48 hours and 3 months in each group. | 48 hours and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Reactivity | Platelet reactivity testing will be performed 10 minutes after infusion has started. | 10 minutes |
| Peripheral Blood Count Quantification | Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khaled Ziada, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26201463 | Background | Keating GM. Cangrelor: A Review in Percutaneous Coronary Intervention. Drugs. 2015 Aug;75(12):1425-34. doi: 10.1007/s40265-015-0445-3. | |
| 26672598 | Background | Johnson TW, Mumford AD, Scott LJ, Mundell S, Butler M, Strange JW, Rogers CA, Reeves BC, Baumbach A. A Study of Platelet Inhibition, Using a 'Point of Care' Platelet Function Test, following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction [PINPOINT-PPCI]. PLoS One. 2015 Dec 16;10(12):e0144984. doi: 10.1371/journal.pone.0144984. eCollection 2015. |
| Label | URL |
|---|---|
| Related Info | View source |
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Patients were randomized upon recruitment to the standard of care alone or standard of care in addition to cangrelor
Patients were recruited in the cardiac catheterization laboratory.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cangrelor | Patients received standard of care in addition to cangrelor with a dose of 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion, started prior to PPCI, and continued for 2 hours or for the duration of the procedure, whichever is longer. |
| FG001 | No Cangrelor | This arm received standard of care alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cangrelor | The final subject count in this arm is 13. |
| BG001 | No Cangrelor | The final subject number in this arm is 9. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Myocardial Infarction Size | Cardiac MRI is obtained at 48 hours and 3 months to compare differences in infarct size. The outcome is assessed as the difference in infarct size between 48 hours and 3 months in each group. | standard of care alone vs. Standard of care in addition to cangrelor | Posted | Mean | Standard Error | percent of left ventricular mass | 48 hours and 3 months |
|
48 hours
bleeding
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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 | Cangrelor | The final subject count in this arm is 13. | 0 |
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The study was terminated because of slow recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Khaled M. Ziada | University of Kentucky | 8593236036 | khaled.ziada@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2017 | May 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C117446 | cangrelor |
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|
| 6 hours |
| Interferon (IFN)-α2 | ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL. | 6 hours |
| IFN-γ | ELISA assay. | 6 hours |
| Macrophage-derived Chemokine | ELISA assay macrophage-derived chemokine | 6 hours |
| 23500251 | Background | Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013 Apr 16;61(15):1601-6. doi: 10.1016/j.jacc.2013.01.024. Epub 2013 Mar 22. |
| 19264241 | Background | Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030. |
| 22447888 | Background | Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, Ochala A, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM; INFUSE-AMI Investigators. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA. 2012 May 2;307(17):1817-26. doi: 10.1001/jama.2012.421. Epub 2012 Mar 25. |
| 33258102 | Derived | Abo-Aly M, George B, Shokri E, Chelvarajan L, El-Helw M, Smyth SS, Abdel-Latif A, Ziada K. Cangrelor in addition to standard therapy reduces cardiac damage and inflammatory markers in patients with ST-segment elevation myocardial infarction. J Thromb Thrombolysis. 2021 Oct;52(3):934-940. doi: 10.1007/s11239-020-02345-8. Epub 2020 Nov 30. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Diabetes | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Peripehral vascular disease | Count of Participants | Participants |
|
| No prior platelet therapy | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Platelet Reactivity | Platelet reactivity testing will be performed 10 minutes after infusion has started. | standard of care alone vs. Standard of care in addition to cangrelor | Posted | Mean | Standard Error | seconds | 10 minutes |
|
|
|
| Secondary | Peripheral Blood Count Quantification | Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes. | standard of care alone vs. Standard of care in addition to cangrelor | Posted | Mean | Standard Error | cells per microliter | 6 hours |
|
|
|
| Secondary | Interferon (IFN)-α2 | ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL. | Plasma level | Posted | Mean | Standard Error | pg/mL | 6 hours |
|
|
|
| Secondary | IFN-γ | ELISA assay. | Plasma levels | Posted | Mean | Standard Error | pg/mL | 6 hours |
|
|
|
| Secondary | Macrophage-derived Chemokine | ELISA assay macrophage-derived chemokine | plasma levels | Posted | Mean | Standard Error | pg/mL | 6 hours |
|
|
|
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | No Cangrelor | The final subject number in this arm is 9. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |