NCT04927949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

June 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 2, 2026

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

May 27, 2021

Last Update Submit

March 30, 2026

Conditions

ST-elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Grade of myocardial blush

    myocardial blush grade from 0 to 3 (normal)

    during procedure

Secondary Outcomes (5)

  • percentage of residual thrombus burden

    during procedure

  • measure of platelet reactivity

    during procedure

  • troponin

    day 1

  • infarct size and no reflow on MRI

    during hospitalization assessed up to 7 days

  • clinical outcomes

    during hospitalization assessed up to 7 days

Study Arms (3)

patients without HPR

SHAM COMPARATOR

standard primary PCI

Procedure: standard PCI

patients with HPR randomized to cangrelor

EXPERIMENTAL

Cangrelor perfusion started before PCI

Drug: cangrelor perfusion during PCI

patients with HPR randomized to standard of care

PLACEBO COMPARATOR

standard primary PCI

Procedure: standard PCI

Interventions

cangrelor perfusion during PCIDRUG

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

patients with HPR randomized to cangrelor
standard PCIPROCEDURE

primary PCI without cangrelor

patients with HPR randomized to standard of carepatients without HPR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAEN University Hospital

Caen, 14000, France

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 16, 2021

Study Start

June 8, 2021

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

April 2, 2026

Record last verified: 2023-01

Locations

FR(1)