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| Name | Class |
|---|---|
| Terumo Medical Corporation | INDUSTRY |
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This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor -a potent and immediate P2Y12 inhibitor- to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.
Despite the use of potent P2Y12 inhibitor such as ticagrelor, half of the patients presented high platelet reactivity (HPR) at the time of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). HPR has been associated with impaired myocardial reperfusion. Myocardial reperfusion, assessed using myocardial blush grade, is a strong prognostic factor associated with infarct size and mortality. Antiplatelet therapy intensification using a potent and immediate P2Y12 inhibitor such as Cangrelor according a point-of-care platelet function test has not been studied in the acute phase of STEMI.
This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients without HPR | Sham Comparator | standard primary PCI |
|
| patients with HPR randomized to cangrelor | Experimental | Cangrelor perfusion started before PCI |
|
| patients with HPR randomized to standard of care | Placebo Comparator | standard primary PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cangrelor perfusion during PCI | Drug | Cangrelor perfusion (started before PCI) with intravenous bolus of 30 microgram/kg, followed by a perfusion of 4 microgram/kg/min during 2 hours or until the end of the PCI if longer |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of myocardial blush | myocardial blush grade from 0 to 3 (normal) | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of residual thrombus burden | intrastent residual thrombus burden assessed by optical coherence tomography | during procedure |
| measure of platelet reactivity | Platelet reactivity using VerifyNow after PCI for patients with basal platelet reaction unit>208 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAEN University Hospital | Caen | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | V Roule, R Stettler, K Blanchart, M Bignon, A Lemaitre, C Peron, P Guedeney, M Zeitouni, L Schwob, R Sabatier, G Montalescot, J J Parienti, F Beygui, Cangrelor use in ticagrelor-loaded ST-elevation myocardial infarction patients with high residual platelet reactivity: a randomized controlled trial, European Heart Journal, Volume 45, Issue Supplement_1, October 2024, ehae666.1637, https://doi.org/10.1093/eurheartj/ehae666.1637 |
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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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| standard PCI | Procedure | primary PCI without cangrelor |
|
| during procedure |
| troponin | peak value | day 1 |
| infarct size and no reflow on MRI | during hospitalization assessed up to 7 days |
| clinical outcomes | death, new myocardial infarction, stent thrombosis, new revascularization, stroke, major bleeding | during hospitalization assessed up to 7 days |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |