Clinical trial NCT04927949: Evaluation of Myocardial Reperfusion After Primary PCI in Patients With High Platelet Reactivity Treated by Cangrelor or Not
Official title: Evaluation of Myocardial Reperfusion and Residual Thrombotic Burden After Primary PCI for STEMI in Patients With High on Ticagrelor Platelet Reactivity Treated by IV Cangrelor Versus Ticagrelor Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ST-elevation Myocardial Infarction
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Terumo Medical Corporation
First posted: 2021-06-16
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Grade of myocardial blush
timeFrame: during procedure
Secondary outcomes:
measure: percentage of residual thrombus burden
timeFrame: during procedure
measure: measure of platelet reactivity
timeFrame: during procedure
measure: troponin
timeFrame: day 1
measure: infarct size and no reflow on MRI
timeFrame: during hospitalization assessed up to 7 days
measure: clinical outcomes
timeFrame: during hospitalization assessed up to 7 days
Other outcomes:
Locations:
city: Caen
country: France
facility: CAEN University Hospital
Study officials:
References: