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RecruitingNCT06223607Updated Jun 10, 2026

Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia

An observational study in Baseline Thrombocytopenia, sponsored by Methodist Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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

02

Conditions studied

  • Baseline Thrombocytopenia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

Exclusion Criteria:

  • Death within 48 hours post-PCI
  • DAPT prior to cardiac catheterization
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Incidence of bleeding

    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.

    Time frame: 1 year

Secondary outcomes

  1. Incidence of ischemic events

    number of ischemic events

    Time frame: 1 year

  2. All-cause mortality

    all-cause mortality in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.

    Time frame: 1 year

  3. Duration of DAPT

    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.

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Methodist Dallas Medical Center
    Dallas, Texas 75203, United States
    • Colette Ngo Ndjom · Contact · mhsirb@mhd.com · 214-947-4681
    • Bethany Brauer · Contact · mhsirb@mhd.com · 214-947-4681
    • Jessica Rago Crotty, Pharm D · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT06223607
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Jan 25, 2024
Start date
Aug 22, 2022
Primary completion
Dec 28, 2026 (estimated)
Completion
Dec 22, 2027 (estimated)
Last update
Jun 10, 2026

Study contacts

Bethany Brauer
Contact
mhsirb@mhd.com
214-947-4681 ext. 74681
Colette Ngo Ndjom
Contact
mhsirb@mhd.com
214-947-1289 ext. 71289
Jessica Rago Crotty, Pharm D
principal investigator · Methodist Midlothian Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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