Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia

January 16, 2024 updated by: Methodist Health System
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).

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bethany Brauer
  • Phone Number: 74681 214-947-4681
  • Email: mhsirb@mhd.com

Study Contact Backup

  • Name: Colette Ngo Ndjom
  • Phone Number: 71289 214-947-1289
  • Email: mhsirb@mhd.com

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Methodist Dallas Medical Center
        • Contact:
          • Bethany Brauer
          • Phone Number: 74681 214-947-4681
          • Email: mhsirb@mhd.com
        • Contact:
          • Colette Ngo Ndjom
          • Phone Number: 71289 214-947-4681
          • Email: mhsirb@mhd.com
        • Principal Investigator:
          • Jessica Rago Crotty, Pharm D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population of 18 years of age ,PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021) ,Thrombocytopenia on at least one occasion prior to PCI and at least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of bleeding
Time Frame: 1 year
To evaluate the difference in bleeding rates in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ischemic events
Time Frame: 1 year
number of ischemic events
1 year
All-cause mortality
Time Frame: 1 year
all-cause mortality in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.
1 year
Duration of DAPT
Time Frame: 1 year
To evaluate the difference in rate of ischemic events and all-cause mortality in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Jessica Rago Crotty, Pharm D, Methodist Midlothian Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2022

Primary Completion (Estimated)

August 22, 2024

Study Completion (Estimated)

August 22, 2024

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 036.PHA.2022.D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Baseline Thrombocytopenia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe