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Trial record 28 of 508 for:    ASPIRIN AND P2

OFDI-Quantified Intracoronary Thrombus, Antiplatelet Pretreatment Effect and Myocardial Reperfusion (ODIPP)

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ClinicalTrials.gov Identifier: NCT03342521
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

The management of ST-elevation myocardial infarction in the acute phase requires an optimal antiaggregation combining aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor). Primary percutaneous coronary intervention must be performed within 2 hours of first medical contact. However, even with the new P2Y12 inhibitors, effective platelet inhibition which is required to inhibit the progression of intracoronary thrombus, is present only in half of the patients at 2 hours.

Optical coherence tomography (OCT) is the reference method for visualizing and quantifying intracoronary thrombus. The post-stenting intracoronary residual mass evaluated in OCT was associated with altered myocardial reperfusion indices, which were themselves associated with the prognosis of the patient. However, the determinants of this post-stenting residual mass -mostly thrombotic- remain unknown.

Measurement of platelet reactivity (expressed as P2Y12 Reaction Unit and Aspirin Reaction Unit) by simple turbidimetric tests (VerifyNow) is available in the cathlab. Enhanced platelet reactivity is reported in patients with acute coronary syndrome and represents a high-risk situation for recurrent coronary events in this setting.

The study aims to:

  1. to evaluate the relationship between the post-stenting residual intracoronary mass evaluated in OCT and the platelet response at the time of the PCI evaluated by Verify Now
  2. to confirm the impact of the residual mass measured by OCT on the EKG and angiographic myocardial reperfusion indices
  3. identify patients with high thrombotic risk who may require more intensive antithrombotic therapy
  4. identify simple biological markers associated with the residual mass measured by OCT

Condition or disease Intervention/treatment
Myocardial Infarction Thrombosis, Coronary Diagnostic Test: optical coherence tomography and VerifyNow

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optical Frequency Domain Imaging-Quantified Intracoronary Thrombus Mass During Primary Percutaneous Coronary Intervention, Its Relationship With Antiplatelet Pretreatment Effect And Its Impact On Myocardial Reperfusion
Actual Study Start Date : October 13, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: optical coherence tomography and VerifyNow
    optical coherence tomography Imaging P2Y12 and Aspirin reaction units quantification by the VerifyNow


Primary Outcome Measures :
  1. the volume of residual intrastent mass measured by OCT [ Time Frame: day 0 ]
    volume of the residual mass in mm3

  2. the platelet reactivity assessed by VerifyNow [ Time Frame: day 0 ]
    P2Y12 and aspirin reaction units, assessed by VerifyNow


Secondary Outcome Measures :
  1. regression of EKG ST-segment elevation [ Time Frame: day 0 ]
    regression of ST-segment elevation >50% after angioplasty

  2. Corrected Timi Frame count [ Time Frame: day 0 ]
    TIMI frame count (number) assessed after angioplasty

  3. Myocardial blush grade [ Time Frame: day 0 ]
    Blush grade (from 0= no blush; 1=minimal; 2=moderate to 3= normal blush) assessed on angiography after angioplasty

  4. angiographic pre-stenting thrombus grade [ Time Frame: day 0 ]
    angiographic thrombus grade score (from 0=no thrombus to 5=occlusive thrombus)

  5. troponin [ Time Frame: day 0 ]
    biological marker (µg/L)

  6. fibrinogen [ Time Frame: day 0 ]
    biological marker (in g/L)

  7. albumin [ Time Frame: day 0 ]
    biological marker (in g/L)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients admitted in our hospital for primary PCI for ST-elevation myocardial infarction treated with successful stenting who had OCT and VerifyNow in the acute phase
Criteria

Inclusion Criteria:

  • primary PCI with successful stenting for ST-elevation myocardial infarction
  • pretreated with ticagrelor, aspirin and enoxaparin
  • OCT and verifyNow performed in the acute phase

Exclusion Criteria:

  • stent thrombosis
  • known coagulation disorder
  • clinical instability
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342521


Locations
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France
CAEN University Hospital
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Principal Investigator: vincent ROULE, MD University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03342521     History of Changes
Other Study ID Numbers: 17-107
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
myocardial infarction
optical coherence tomography
intracoronary thrombus
VerifyNow
Additional relevant MeSH terms:
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Myocardial Infarction
Thrombosis
Coronary Thrombosis
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Coronary Disease