Impact of Timing of PD Assessments on Measures of Platelet Reactivity in Patients Undergoing PCI Treated With Cangrelor
Impact of Timing of Pharmacodynamic Assessments on Measures of Platelet Reactivity in Patients Undergoing Percutaneous Coronary Intervention Treated With Cangrelor
1 other identifier
observational
17
1 country
1
Brief Summary
This study is assessing the impact of timing of PD assessments on measures of platelet reactivity in patients undergoing PCI treated with cangrelor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2020
CompletedFirst Posted
Study publicly available on registry
December 16, 2020
CompletedStudy Start
First participant enrolled
January 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2021
CompletedSeptember 14, 2021
September 1, 2021
2 months
December 9, 2020
September 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in platelet reactivity
measure of change platelet reactivity at time points
wiithin 30 min, 1 hour, 2 hours, and 4 hours of blood sampling
Study Arms (1)
Cangrelor Group
This is the study cohort that the blood sample will be obtained from. There are no interventions
Eligibility Criteria
Patients who are undergoing percutaneous coronary intervention (PCI) and have been treated with cangrelor per standard of care.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Chiesi Farmaceutici S.p.A.collaborator
Study Sites (1)
University of Florida
Jacksonville, Florida, 32209, United States
Related Publications (1)
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.
PMID: 34736741DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominick Angiolillo, MD, PhD
Professor of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2020
First Posted
December 16, 2020
Study Start
January 28, 2021
Primary Completion
April 4, 2021
Study Completion
July 20, 2021
Last Updated
September 14, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share