ST-elevation Myocardial Infarction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGcangrelor perfusion during PCI
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
PROCEDUREstandard PCI
primary PCI without cangrelor
Sponsors
University Hospital, Caen
Terumo Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient admitted for STEMI within 24 hours from symptom onset * pretreated with ticagrelor, aspirin and enoxaparin (according local protocol) * successfully treated by primary PCI of a native coronary culprit lesion * anatomy accessible to optical coherence tomography (OCT or OFDI)
Exclusion criteria
* cardiogenic shock * stent restenosis or thrombosis * use of glycoprotein IIb/IIIa inhibitors before or during PCI * known coagulation disease * high bleeding risk (thrombocytopenia \<100,000/dL, surgery \<30 days, active bleeding) * uncontrolled arterial hypertension (\>180/110 mmHg) * history of stroke (ischemic or hemorrhagic) or transient ischemic attack * known severe renal insufficiency (eGFR \<30 ml/min) * oral anticoagulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade of myocardial blush | during procedure | myocardial blush grade from 0 to 3 (normal) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of residual thrombus burden | during procedure | intrastent residual thrombus burden assessed by optical coherence tomography |
| measure of platelet reactivity | during procedure | Platelet reactivity using VerifyNow after PCI for patients with basal platelet reaction unit\>208 |
| troponin | day 1 | peak value |
| infarct size and no reflow on MRI | during hospitalization assessed up to 7 days | — |
| clinical outcomes | during hospitalization assessed up to 7 days | death, new myocardial infarction, stent thrombosis, new revascularization, stroke, major bleeding |
Countries
France
Outcome results
None listed