Impact of Timing of PD Assessments on Measures of Platelet Reactivity in Patients Undergoing PCI Treated With Cangrelor

NCT ID: NCT04668495

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-28

Study Completion Date

2021-07-20

Brief Summary

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This study is assessing the impact of timing of PD assessments on measures of platelet reactivity in patients undergoing PCI treated with cangrelor.

Detailed Description

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Cangrelor is characterized by reversible binding to the P2Y12 receptor and is promptly inactivated through dephosphorylation by ectonucleotidase leading to its very short plasma half-life. Consequently the timing at which PD assessments are performed after blood sample collection may impact measures of platelet reactivity in patients treated with cangrelor. We therefore hypothesize that measures of platelet inhibitory effects observed in cangrelor treated patients will reduce with time following blood sampling.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cangrelor Group

This is the study cohort that the blood sample will be obtained from. There are no interventions

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years old
* CAD patients (stable CAD, NSTE-ACS, or STEMI) undergoing PCI and treated with cangrelor per standard of care.
* Treated with aspirin prior to the PCI procedure per standard of care

Exclusion Criteria

* Treatment with an oral P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) within past 10 days
* Treatment with oral anticoagulation (vitamin K antagonist, dabigatran, apixaban, rivaroxiban) within past 3 days
* Treatment with a glycoprotein IIb/IIIa inhibitor during PCI
* Fibrinolytics within 48 hours
* Known hemoglobin\<10 gm/dL
* Known platelet count \<80x106/mL
* Active bleeding or hemodynamic instability
* Known end stage renal disease on hemodialysis
* Known severe hepatic dysfunction
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominick Angiolillo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine

Locations

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University of Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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Franchi F, Rollini F, Galli M, Been L, Ghanem G, Shalhoub A, Rivas A, Zhou X, Pineda AM, Suryadevara S, Soffer D, Zenni MM, Bass TA, Angiolillo DJ. Impact of Timing of Pharmacodynamic Assessment on Platelet Reactivity in Patients Treated With Cangrelor. JACC Cardiovasc Interv. 2021 Nov 8;14(21):2410-2412. doi: 10.1016/j.jcin.2021.07.051. No abstract available.

Reference Type DERIVED
PMID: 34736741 (View on PubMed)

Other Identifiers

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Cangrelor Timing

Identifier Type: -

Identifier Source: org_study_id

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