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

Primary Purpose

ST-elevation Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
cangrelor perfusion during PCI
standard PCI
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CAEN University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Placebo Comparator

Arm Label

patients without HPR

patients with HPR randomized to cangrelor

patients with HPR randomized to standard of care

Arm Description

standard primary PCI

Cangrelor perfusion started before PCI

standard primary PCI

Outcomes

Primary Outcome Measures

Grade of myocardial blush
myocardial blush grade from 0 to 3 (normal)

Secondary Outcome Measures

percentage of residual thrombus burden
intrastent residual thrombus burden assessed by optical coherence tomography
measure of platelet reactivity
Platelet reactivity using VerifyNow after PCI for patients with basal platelet reaction unit>208
troponin
peak value
infarct size and no reflow on MRI
clinical outcomes
death, new myocardial infarction, stent thrombosis, new revascularization, stroke, major bleeding

Full Information

First Posted
May 27, 2021
Last Updated
September 13, 2023
Sponsor
University Hospital, Caen
Collaborators
Terumo Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04927949
Brief Title
Evaluation of Myocardial Reperfusion After Primary PCI in Patients With High Platelet Reactivity Treated by Cangrelor or Not
Acronym
ERMIT
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Terumo Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients without HPR
Arm Type
Sham Comparator
Arm Description
standard primary PCI
Arm Title
patients with HPR randomized to cangrelor
Arm Type
Experimental
Arm Description
Cangrelor perfusion started before PCI
Arm Title
patients with HPR randomized to standard of care
Arm Type
Placebo Comparator
Arm Description
standard primary PCI
Intervention Type
Drug
Intervention Name(s)
cangrelor perfusion during PCI
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
standard PCI
Intervention Description
primary PCI without cangrelor
Primary Outcome Measure Information:
Title
Grade of myocardial blush
Description
myocardial blush grade from 0 to 3 (normal)
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
percentage of residual thrombus burden
Description
intrastent residual thrombus burden assessed by optical coherence tomography
Time Frame
during procedure
Title
measure of platelet reactivity
Description
Platelet reactivity using VerifyNow after PCI for patients with basal platelet reaction unit>208
Time Frame
during procedure
Title
troponin
Description
peak value
Time Frame
day 1
Title
infarct size and no reflow on MRI
Time Frame
during hospitalization assessed up to 7 days
Title
clinical outcomes
Description
death, new myocardial infarction, stent thrombosis, new revascularization, stroke, major bleeding
Time Frame
during hospitalization assessed up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CAEN University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

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

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