Evaluation of Myocardial Reperfusion After Primary PCI in Patients With High Platelet Reactivity Treated by Cangrelor or Not

Phase 4

Completed

• Conditions: ST-elevation Myocardial Infarction
• Interventions: Drug: cangrelor perfusion during PCI; Procedure: standard PCI

• Registration Number: NCT04927949
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Study First Submitted: 2021-05-27
• Study Start: 2021-06-08
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Status Verified: 2023-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with HPR randomized to cangrelor	cangrelor perfusion during PCI	Cangrelor perfusion started before PCI
patients without HPR	standard PCI	standard primary PCI
patients with HPR randomized to standard of care	standard PCI	standard primary PCI

Primary Outcome Measures

Name	Time	Method
Grade of myocardial blush	during procedure	myocardial blush grade from 0 to 3 (normal)

Secondary Outcome Measures

Name	Time	Method
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
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
troponin	day 1	peak value

Trial Locations

Locations (1)

CAEN University Hospital; 🇫🇷 Caen, France