Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia

NCT ID: NCT06223607

Last Updated: 2024-01-25

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

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-22

Study Completion Date

2024-08-22

Brief Summary

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The use of clopidogrel as part of DAPT will be associated with lower bleeding rates compared to ticagrelor in patients with chronic thrombocytopenia requiring Percutaneous intervention (PCI )with Drug Eluting Stent (DES) or Bare Metal Stint(BMS).

Detailed Description

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Patients with thrombocytopenia are at an increased risk of both bleeding and ischemic events following PCI; however, there is a paucity of data on how to optimally manage these risks. Data indicates that ticagrelor is associated with reduced ischemic outcomes with an accompanying increased risk of bleed in the broader population. This study will assess P2Y12 agent selection in patients with chronic thrombocytopenia to determine if one better balances risks of ischemic and bleeding events following coronary intervention

Conditions

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Baseline Thrombocytopenia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years
* PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021)
* Thrombocytopenia defined as platelet count \<100 x103 /µL on at least one occasion prior to PCI
* At least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor

Exclusion Criteria

* Death within 48 hours post-PCI
* DAPT prior to cardiac catheterization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica Rago Crotty, Pharm D

Role: PRINCIPAL_INVESTIGATOR

Methodist Midlothian Medical Center

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bethany Brauer

Role: CONTACT

214-947-4681 ext. 74681

Colette Ngo Ndjom

Role: CONTACT

214-947-1289 ext. 71289

Facility Contacts

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Colette Ngo Ndjom

Role: primary

214-947-4681 ext. 71289

Bethany Brauer

Role: backup

214-947-4681 ext. 74681

Other Identifiers

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036.PHA.2022.D

Identifier Type: -

Identifier Source: org_study_id

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